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Glaucoma Drainage

Devices
A Practical Illustrated Guide
Monica Gandhi
Shibal Bhartiya 
Editors

123
Glaucoma Drainage Devices
Monica Gandhi  •  Shibal Bhartiya
Editors

Glaucoma Drainage
Devices
A Practical Illustrated Guide
Editors
Monica Gandhi Shibal Bhartiya
Dr. Shroff’s Charity Eye Hospital Fortis Memorial Research Institute
New Delhi Gurgaon
India India

ISBN 978-981-13-5772-5    ISBN 978-981-13-5773-2 (eBook)


https://doi.org/10.1007/978-981-13-5773-2

© Springer Nature Singapore Pte Ltd. 2019


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Preface

Glaucoma Drainage Devices: A Practical Illustrated Guide is the collabora-


tive effort of some of the best clinician scientists and surgeons across the
globe. We have tried our best to keep this book free of unnecessary text, con-
centrating more on what is relevant clinically, emphasizing on the surgical
technique. You will find the book full of algorithms and flowcharts and lots of
images for illustration of surgical steps. Each of the chapters is accompanied
by videos that demonstrate the surgical techniques and tips and tricks that
improve surgical outcomes. There are enough videos by some of the most
skilled surgeons in the world, detailing modifications of surgical techniques
which you can try in your surgical practice and choose one that suits you best.
You will, therefore, find the Glaucoma Drainage Devices: A Practical
Illustrated Guide to be a handy reference for when you are in the glaucoma
clinic, deliberating what would be the best choice for your patient, surgically.
You will find that the book and the accompanying videos are your best friends
when you are learning how to implant a glaucoma drainage device or to refine
your technique. So whether you are a glaucoma surgeon in training or a
trained glaucoma practitioner, we are sure this book will prove to be invalu-
able in your operating room.
We hope you enjoy reading the book to be a learning experience, editing it
has definitely changed the way we look at glaucoma drainage devices in our
clinical practice.
With best wishes,

New Delhi, India Monica Gandhi


Gurgaon, India  Shibal Bhartiya

v
Contents

1 The Glaucoma Treatment Paradigm: An Overview ��������������������   1


Shibal Bhartiya, Parul Ichhpujani, and Monica Gandhi
2 Indications of Glaucoma Drainage Implant����������������������������������   7
Julie Pegu, Amit Purang, and Monica Gandhi
3 The Glaucoma Drainage Devices: Types and Models������������������  13
Bhumika Sharma, Monica Gandhi, and Usha Yadava
4 Preparing the Patient for the Glaucoma Drainage
Device Surgery���������������������������������������������������������������������������������  19
Parul Ichhpujani
5 The Ideal Glaucoma Drainage Device:
Which One to Choose?��������������������������������������������������������������������  25
Purvi Bhagat
6 Surgical Technique of Implantation: AGV,
Limbal Variant ��������������������������������������������������������������������������������  33
Shibal Bhartiya and Monica Gandhi
7 Pars Plana Ahmed Glaucoma Valve: Surgical Technique������������  39
Gowri J. Murthy, Praveen R. Murthy, and Shaifali Chahar
8 Surgical Technique for Baerveldt Glaucoma Devices������������������  47
Gurjeet Jutley and Laura Crawley
9 Molteno Implants: Surgical Technique������������������������������������������  57
Parth R. Shah, Ashish Agar, and Colin I. Clement
10 AADI Technique������������������������������������������������������������������������������  67
Suresh Kumar and Sahil Thakur
11 Glaucoma Drainage Devices in Special Cases ������������������������������  73
Sirisha Senthil
12 Combined Surgeries: Glaucoma Drainage Devices
and Cataract ������������������������������������������������������������������������������������  79
Sagarika Patyal, Santosh Kumar, and Suneeta Dubey

vii
viii Contents

13 Glaucoma Drainage Devices (Ahmed Glaucoma Valve)


in Penetrating Keratoplasty-­Associated Glaucoma����������������������  85
Madhu Bhadauria
14 Combined Surgeries: Glaucoma Drainage Devices
with Boston KPro ����������������������������������������������������������������������������  93
Suneeta Dubey, Nidhi Gupta, Madhu Bhoot,
and Shalini Singh
15 Glaucoma Drainage Devices in Children�������������������������������������� 101
Oscar Daniel Albis-Donado and Alejandra Hernandez-Oteyza
16 Modifications of Surgical Techniques in Glaucoma
Drainage Devices������������������������������������������������������������������������������ 109
Kleyton Barella and Vital Paulino Costa
17 Glaucoma Drainage Devices: Complications
and Their Management ������������������������������������������������������������������ 117
Bhumika Sharma, Monica Gandhi, Suneeta Dubey,
and Usha Yadava
18 Postoperative Care and Follow-Up of the Patient
with Glaucoma Drainage Devices�������������������������������������������������� 127
Sushmita Kaushik and Gunjan Joshi
19 Histological Considerations of Glaucoma
Drainage Devices������������������������������������������������������������������������������ 135
Nadia Ríos-Acosta and Sonia Corredor-Casas
20 Economic Considerations of Glaucoma
Drainage Devices������������������������������������������������������������������������������ 143
Maneesh Singh and Arijit Mitra
21 Quality of Life Following Glaucoma
Drainage Device Surgery���������������������������������������������������������������� 149
Bernardo de Padua Soares Bezerra, Syril Dorairaj,
and Fabio Nishimura Kanadani
22 Important Clinical Trials in Glaucoma
Drainage Devices������������������������������������������������������������������������������ 155
Monica Gandhi, Anupma Lal, and Shibal Bhartiya
23 Newer Devices for Aqueous Drainage�������������������������������������������� 163
Reena Choudhry, Isha Vatsal, and Foram Desai
About the Editors

Monica  Gandhi  is currently working as Associate Medical Director and


Senior Consultant in Glaucoma and Anterior Segment Services at Dr. Shroff’s
Charity Eye Hospital, New Delhi, India. She is an alumnus of Maulana Azad
Medical College and Guru Nanak Eye Centre, under the University of Delhi.
A former glaucoma fellow at the Glaucoma Imaging Centre under Prof. NN
Sood, she has several publications and book chapters on glaucoma to her
credit. Besides her keen interest in clinical and surgical training for fellows,
she is also committed to mentoring fellows and trainees in their research
work.

Shibal Bhartiya  is currently working as a senior consultant glaucoma sur-


geon at Fortis Memorial Research Institute, Gurgaon, and Fortis Flt. Lt. Rajan
Dhall Hospital, New Delhi, India. She has a special interest in glaucoma
diagnosis and management and ocular surface diseases. She was a senior
clinical research fellow in the glaucoma services of the Department of
Clinical Neurosciences, University of Geneva, Switzerland. Prior to that, she
did her glaucoma training as senior research associate in the cornea and glau-
coma services at Dr. R P Centre for Ophthalmic Sciences, AIIMS, New Delhi.
She has published extensively on glaucoma, contributing numerous arti-
cles and book chapters alike. She has coedited the prestigious ISGS Textbook
of Glaucoma Surgery, Manual of Glaucoma, and Practical Perimetry; has
coauthored Living with Glaucoma; and is the managing editor of the Video
Atlas of Glaucoma Surgery.
An avid educator and researcher, she has been responsible for the design
and execution of many clinical trials involving both clinical and basic
research. She serves as a reviewer for many ophthalmology journals and is
the executive editor of the Journal of Current Glaucoma Practice, the official
journal of the International Society of Glaucoma Surgery. She is also the edi-
tor in chief of Clinical and Experimental Vision and Eye Research.

ix
The Glaucoma Treatment
Paradigm: An Overview 1
Shibal Bhartiya, Parul Ichhpujani,
and Monica Gandhi

1.1 Introduction is unlikely to affect the patient’s quality of life. Risk


stratification helps to guide target IOP (Table 1.1).
The only evidence-based, accepted, and the most The burdens and risks of therapy should be bal-
practiced therapeutic modality for management anced against the risk of disease progression [1].
of glaucoma patients is reducing intraocular pres- Therefore, important determinants when pre-
sure. Topical ocular hypotensive medications, as scribing include choosing drugs with maximal
well as laser and incisional glaucoma filtering efficacy, compliance, safety, persistence, and
surgeries, all aim to decrease the IOP, thereby affordability (Table 1.2).
preventing visual field damage by decreasing the Regular follow-up is necessary to detect pro-
rate of retinal ganglion cells death. gression and reassess target IOP, which might
This chapter aims to provide an objective require escalation or downregulation of therapy.
overview of current glaucoma practice in order to The follow-up duration depends on the stage of
help decision-making for clinicians. the disease, stability, and access to healthcare [2].

1.2 Medical Management 1.2.2 How to Augment Therapy


of Glaucoma
In case, monotherapy is unable to meet the tar-
1.2.1 How to Initiate Therapy get IOP, and the first drug has been proven to be
efficacious, a second drug may be added to the
The primary aim of medical treatment is to obtain treatment protocol. Advantages of fixed combi-
the target IOP, which is defined as the IOP range at nation preparations include ease of use, improved
which the clinician judges that progressive disease patient adherence, less preservative toxicity, and
better tolerability.
S. Bhartiya (*) Maximal Medical Therapy (MMT): Maximal
Department of Ophthalmology, Fortis Memorial medical therapy can be defined as the minimum
Research Institute, Gurgaon, India number and concentration of drugs (within the
P. Ichhpujani (*) combination of different classes of medications)
Department of Ophthalmology, Government Medical that provides maximum lowering of IOP.  It has
College and Hospital, Chandigarh, India
to take into account factors including efficacy,
M. Gandhi (*) compliance, tolerability, and affordability of
Department of Ophthalmology, Dr Shroff’s Charity
­glaucoma treatment, customized to the needs of
Eye Hospital, New Delhi, India
the individual patient.
© Springer Nature Singapore Pte Ltd. 2019 1
M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_1
2 S. Bhartiya et al.

Table 1.1  Risk categories to guide treatment targets for POAG (Adapted from Asia-Pacific Glaucoma Guidelines, 2nd
edition, 2008)
Risk category Description Treatment targets
High Moderate to advanced GON with VFD ≥40% IOP reduction or
Higher IOP 1–2 SD below population
Rapid progression mean (9–12 mmHg)
Bilateral visual field defects
Pigmentary or pseudoexfoliative glaucoma
Split fixation
Glaucoma-related visual disability
Younger age
Moderate Mild GON with early VFD >30% IOP reduction or
Mild-moderate GON with low IOP population mean
Younger age
Glaucoma Fellow eye of established GON: (excluding secondary unilateral Monitor closely for
suspect with glaucoma) change or treat depending
moderate OHTN with multiple risk factors: thin CCT, high IOP, suspicious discs on risk and patient
risk GLC gene mutations associated with severe POAG preferences
Recurrent disc hemorrhages Treat if risk(s) increase(s)
Pseudoexfoliation with ≥20% IOP reduction
Younger age or 1 SD above population
mean
Glaucoma OHTN Monitor
suspect with Older age
low risk Pigment dispersion with normal IOP
Disc suspect
Positive family history of glaucoma
Less important:
 Steroid responder
 Myopia
 β-peripapillary atrophy
 Diabetes mellitus
 Uveitis
 Systemic hypertension
GON glaucomatous optic neuropathy, VFD visual field defects, IOP intraocular pressure, OHTN ocular hypertension,
SD standard deviation

Table 1.2  Broad classification of common ocular hypotensive agents


IOP-lowering
agent class Important drugs Dosage Side effects Contraindications
Prostaglandin Latanoprost A day, at Red eyes, dry eyes Trimester 3 pregnancy
analogues Travoprost bedtime Iris pigmentation (uterine contractility)
Bimatoprost Eyelid skin darkening Herpes infections of the eye
Tafluprost Longer, thicker lashes Uveitis
β-blockers Timolol (0.25 or Once or Bradycardia Heart block
0.5%) twice a Bronchospasm Asthma/COPD
Betaxolol (0.25 or day Syncope, impotence Caution in heart failure
0.5%) Lipid disturbances Betaxolol is cardioselective
Allergy and has fewer pulmonary
complications
α2-agonists Brimonidine (0.15 or Twice a Allergy, tachyphylaxis Avoid brimonidine in
0.2%), apraclonidine day Hypotension children <10 years of age
Carbonic Brinzolamide Twice or Blurred vision Sulfonamide allergy
anhydrase Dorzolamide thrice a Stinging, of dry eye
inhibitors day Sulfonamides: Stevens-­Johnson
syndrome, blood dyscrasias
Allergy
Cholinergics Pilocarpine (1, 2 or Two to Headache, cataract, epiphora,
4%) four times change in vision, increased
a day salivation, abdominal cramps
1  The Glaucoma Treatment Paradigm: An Overview 3

There are many promising options for glau- 1.3.2 Trabecular Meshwork
coma medical therapy in development such as
netarsudil (a Rho kinase inhibitor), latanopros- (a) Laser Trabeculoplasty: The exact mechanism
tene bunod (a nitric oxide donor and prostaglan- by which trabeculoplasty works is not pre-
din analog), trabodenoson (an adenosine receptor cisely known, but studies have shown that the
agonist), and bamosiran (a small interfering laser energy applied to the trabecular mesh-
RNA) [3]. work initiates structural and/or physiologic
changes that promote aqueous outflow. Types
of trabeculoplasty available include:
1.3 Lasers in Glaucoma • Argon laser trabeculoplasty (ALT)
• Selective laser trabeculoplasty (SLT) [5]
A detailed description of all the laser procedures • Pattern laser trabeculoplasty (PLT)
is beyond the scope of this section; the indica- • Micropulse diode laser trabeculoplasty
tions of each of the procedures and the target tis- (MDLT)
sue are mentioned below [4]. Indications
• Alternative to topical glaucoma medica-
tions as a first-line treatment for open-­
1.3.1 Iris angle glaucoma (OAG)
• OAG (Primary or secondary) patients
(a) Laser Peripheral Iridotomy (LPI): LPI is the uncontrolled on topical medications
preferred procedure for treating angle-­closure • OAG patients noncompliant with
glaucoma caused by relative or absolute medications
pupillary block. LPI eliminates pupillary
block by allowing the aqueous to pass directly
from the posterior chamber into the anterior 1.3.3 Ciliary Body
chamber, bypassing the pupil.
Indications Cyclophotocoagulation
• Acute angle-closure glaucoma (a) Transscleral diode cyclophotocoagulation
• Primary angle-closure glaucoma (TSCPC): TSCPC reduces aqueous
• Aphakic or pseudophakic pupillary block humor production by coagulating proteins
• Occludable angle with acute angle-closure of the pigmented cells. Laser closes
glaucoma in the fellow eye nearby capillaries and ablates the ciliary
• Luxated or subluxated crystalline lens epithelium without destroying the ciliary
• Anterior chamber intraocular lens body itself. This slows the aqueous humor
• Pupillary block from silicone oil after production [6].
vitrectomy Indications
(b) 
Peripheral Iridoplasty: Selected narrow • Refractory patients in whom multiple
angles may be widened by peripheral irido- glaucoma surgeries have failed
plasty, particularly if the narrowing is not due • Patients deemed to be at high risk for
to pupillary block. In iridoplasty, the laser complications after a filtering surgery
causes thermal contraction of stromal colla- • Patients with low visual potential for
gen, which is primarily responsible for the whom an invasive procedure is not
immediate anatomical change. reasonable
Indications (b) Endoscopic cyclophotocoagulation (ECP):
• Plateau iris Endoscopic cyclophotocoagulation (ECP;
• Adjunct for cases that retain appositional Endo Optiks, Little Silver, New Jersey,
closure of the angle after LPI USA) employs a fiber optic cable to
• Cases where an LPI cannot be initially deliver pulsed, continuous-wave diode
created laser energy to the ciliary processes under
4 S. Bhartiya et al.

direct endoscopic visualization using a long-­


term adequate IOP control. It should be
video monitor [7]. minimally cataractogenic, allow rapid visual
Indications recovery, and have the potential to be combined
• Patients with refractory glaucomas, with phacoemulsification without one procedure
often having failed maximum tolerated potentially affecting the outcome of the other.
medical therapy and prior glaucoma Unfortunately, the quest for an ideal glaucoma
surgery procedure is still far from over.
• Refractory glaucoma with relatively Available surgical options include:
good visual potential
• Refractory glaucoma patients who are
on anticoagulation medications or are 1.4.1 Trabeculectomy and
monocular Variations
ECP Plus: ECP via pars plana approach com-
bined with pars plana vitrectomy is an option for Trabeculectomy is the most widely performed
end-stage glaucoma patients in whom multiple glaucoma filtration surgery, where a fistula is
glaucoma surgeries and possibly multiple tube formed through the sclera to subconjunctival
shunts have failed. Due to the distinct angle of space to create a filtering “bleb” [8].
approach, it cannot be performed in phakic eyes. Indications
(a) This is indicated for patients with failed
maximal tolerated antiglaucoma medica-
1.4 Glaucoma Surgery tions or failed laser surgery with any of
the following:
Traditionally, surgery was reserved for patients if • Progressive glaucomatous optic nerve
progression was noted despite maximum medi- head cupping
cal therapy. Other factors like socioeconomic • Glaucomatous visual field progression
considerations, age, bilateral advanced disease, • Anticipated optic nerve head damage
and general health of the patient may warrant a and/or visual field damage as a result of
primary surgery. The decision to operate must excessive IOP
be customized to the individual patient, after a • Intolerable adverse effects from multi-
detailed discussion of risks, benefit, available ple topical antiglaucoma medications
alternatives, and patient preference. • Lack of compliance with anticipated or
Conventional glaucoma surgeries are typi- documented progressive glaucoma
cally reserved for those with moderate to damage
advanced glaucoma due to the invasiveness (b) Variations of trabeculectomy include:
of the procedure and possible complications. • Trabeculectomy with MMC
The newer micro invasive glaucoma surgery • Trabeculectomy with biodegradable
(MIGS) procedures are creating new options collagen matrix (Ologen)
for those with early and moderate glaucoma • Trabeculectomy with Ex-Press shunt
since they have a better safety profile with • Trabeculectomy with adjustable/releas-
fewer complications and a more rapid recovery able sutures
time. They have been shown to be effective in
decreasing IOP as well as a patient’s need for
medications, which becomes relevant because 1.4.2 Glaucoma Drainage Devices
of the low compliance rate reported for medica-
tion adherence. Glaucoma drainage implants are devices, which
An ideal glaucoma procedure is the one that allow aqueous outflow by creating a communi-
is easy to perform, reproducible, with a low cation between the anterior chamber and sub-­
incidence of early postoperative hypotony, and Tenon’s space [9].
1  The Glaucoma Treatment Paradigm: An Overview 5

Indications (a) Deep sclerectomy


(a) These have been used for refractory glau- (b) Viscocanalostomy
comas or those unlikely to respond to the (c) Canaloplasty
conventional filtration surgery, such as:
• Open angle glaucoma with failed
trabeculectomy 1.4.4 M
 inimally Invasive Glaucoma
• Refractory congenital glaucoma Surgeries
• Neovascular glaucoma
• Traumatic glaucoma These procedures may serve as an excellent sur-
• Uveitic glaucoma gical option for patients who require postopera-
• Penetrating keratoplasty with glaucoma tive IOPs in the mid-to-high teens. They may be
• Retinal detachment surgery with offered to patients with primary open-­angle, pig-
glaucoma mentary, and pseudoexfoliative glaucoma. They
• Iridocorneal endothelial syndrome may also be used in patients who have previously
• Sturge-Weber syndrome undergone filtering surgery [11]. These include:
(b) Lately, these are considered as a primary (a) Trabectome
surgical choice over a filtering surgery. (b) Cypass
The implants can be classified as valved (c) Istent
and non-valved. (d) Hydrus
Valved implants (e) Suprachoroidal shunt
• Ahmed glaucoma valve (AGV) (f) Xen gel implant
• Optimed (g) Gonioscopy-assisted transluminal
• Krupin disc trabeculotomy
• Krupin band (h) Excimer laser trabeculotomy
• Joseph Hitchings
Non-valved Implants
• Baerveldt glaucoma implant (BGI) 1.5 Conclusion
• Molteno shunt
• AADI The aim of glaucoma therapy is to preserve vision
• Schoket band and preserve blindness at a cost which is accept-
able to the patient. Therefore, every effort must
be made to treat the patient, and not the intraocu-
1.4.3 Non-penetrating Glaucoma lar pressure. A corollary to this is the need for an
Surgeries individualized therapeutic index, tailored for that
patient only: potential benefit of intervention for
Non-­ penetrating surgeries are based on the that patient, versus the possibility of causing harm.
premise that aqueous egress occurs at the level Patients with early disease, or ocular hyper-
of Schlemm’s canal and its efferents and that the tension, may be offered selective laser trabeculo-
selective removal of the external part of the tra- plasty, as well as the newer conjunctiva sparing
becular meshwork is mainly involved in aqueous surgeries, before embarking on conventional
outflow resistance (inner wall of Schlemm’s canal medical management. Patients presenting with
and the adjacent trabecular meshwork) while advanced, especially bilateral, disease who are at
leaving intact the innermost trabecular meshwork risk of progressing to sight loss despite treatment
layers. Thus the outflow facility is increased should be offered the option of primary surgery.
while retaining a degree of residual outflow resis- There is no “one size fits all” algorithm for
tance by leaving a membrane between the ante- management of glaucoma, and so, the treatment
rior chamber and the scleral dissection [10]. The protocol for each patient must be tailored to their
procedures are: individual needs.
6 S. Bhartiya et al.

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glaucoma. The diode laser ciliary body study group.
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7. Murthy GJ, Murthy PR, Murthy KR, Kulkarni VV,
F. Achievements and limits of current medical therapy
Murthy KR.  A study of the efficacy of endoscopic
of glaucoma. Dev Ophthalmol. 2017;59:1–14.
cyclophotocoagulation for the treatment of refractory
2. Conlon R, Saheb H, Ahmed II.  Glaucoma treat-
glaucomas. Indian J Ophthalmol. 2009;57:127–32.
ment trends: a review. Can J Ophthalmol.
8. Moisseiev E, Zunz E, Tzur R, Kurtz S, Shemesh
2017;52(1):114–24.
G.  Standard trabeculectomy and ex-press miniature
3. Schehlein EM, Novack GD, Robin AL. New classes
glaucoma shunt: a comparative study and literature
of glaucoma medications. Curr Opin Ophthalmol.
review. J Glaucoma. 2015;24(6):410–6.
2017;28(2):161–8.
9. Gedde SJ, Panarelli JF, Banitt MR, Lee
4. Ekici F, Waisbourd M, Katz LJ. Current and future of
RK. Evidenced-based comparison of aqueous shunts.
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Curr Opin Ophthalmol. 2013;24(2):87–95.
Ophthalmol J. 2016;10:56–67.
10. Abdelrahman AM.  Noninvasive glaucoma proce-

5. Zhou Y, Aref AA. A review of selective laser trabecu-
dures: current options and future innovations. Middle
loplasty: recent findings and current perspectives.
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Ophthalmol Ther. 2017;6(1):19–32.
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2017;2017:3182935.
Indications of Glaucoma Drainage
Implant 2
Julie Pegu, Amit Purang, and Monica Gandhi

2.1 Introduction 2.1.1 Traumatic Glaucoma

Tube implants have been in vogue for over three GDIs are indicated in post-trauma eyes with a
decades. Its inception has brought a paradigm conjunctival or scleral injury that precludes con-
shift in the management of secondary glaucomas, ventional filtration surgery. In cases of blunt ocu-
where the only option earlier was cyclodestruc- lar injury with disturbance of lens and the vitreous
tive procedure. From the time of its innovation, body, GDIs are indicated, and the tube is directed
however, it was restricted primarily to patients in a position away from the affected site to pre-
who were at a high risk of failure from conven- vent its blockage by the disturbed vitreous.
tional glaucoma filtration surgery. But the indica-
tions at present encompass a wide variety of
secondary and primary glaucomas. Glaucoma 2.1.2 Inflammatory Glaucoma
drainage implants (GDIs), both valved and non-­
valved, are available. This chapter focuses on the The likelihood of trabeculectomy failing is high if
possible indications of GDIs in the current glau- there is an ongoing inflammation in the eye despite
coma management. treatment, such as in uveitic glaucoma (Fig. 2.1)
GDI surgery is usually indicated in the follow- and neovascular glaucoma (Fig.  2.2). GDIs are
ing settings (Table 2.1): indicated in these cases to control the IOP.

Table 2.1  Common indications of GDI as a primary


1. Patients with failed trabeculectomy/multiple procedure
failed glaucoma surgeries Traumatic glaucoma
2. Secondary glaucomas uncontrolled on maxi- Neovascular glaucoma
mal tolerated medical therapy Uveitic glaucoma
3. Patients at a high risk of failure of conven- Post-penetrating keratoplasty glaucoma
tional glaucoma filtration surgery Glaucoma associated with keratoprosthesis
Silicone oil glaucoma
Glaucoma following vitreoretinal surgery
Infantile/juvenile glaucoma
Glaucoma in aphakia/pseudophakia
ICE syndrome with glaucoma
J. Pegu (*) · A. Purang · M. Gandhi Axenfeld Reigers syndrome with glaucoma
Anterior Segment and Glaucoma Services,
Glaucoma in Sturge-Weber syndrome
Department of Glaucoma, Dr. Shroff’s Charity Eye
Hospital, New Delhi, India Glaucoma due to epithelial ingrowth
Scleral thinning

© Springer Nature Singapore Pte Ltd. 2019 7


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_2
8 J. Pegu et al.

Fig. 2.1  A 24 year old female with chronic uveitis and multiple failed trabeculectomies and uncontrolled IOP

Fig 2.3  A 42 year old patient s/p PKP with Pesudophakia


with IOP 42 mmHg on MMT
Fig. 2.2  A 64 year old patient with NVG and uncon-
trolled IOP is higher. A successful control of IOP after GDI
was noted in 89% [1] to about 92–100% [2] of
2.1.3 Post-penetrating Keratoplasty eyes 1 year after PKP and 82% [1] at the end of
(PPK) Glaucoma 3 years.
The site of placement of GDI is important and
PPK glaucoma is one of the common complica- should be placed as far as possible from the cor-
tions after penetrating keratoplasty (PKP), many neal endothelial surface. Micro movements of
of which may require surgical intervention. In the tube occur with blinking, eye movements,
PPK glaucoma (Fig.  2.3), the surgical choice and eye rubbing which may hasten endothelial
depends on the associated ocular condition. In loss [2, 3] causing graft failure. If the anterior
situations where the conjunctiva is intact with a chamber (AC) is deep, the tube can be comfort-
deep anterior chamber, either trabeculectomy or ably placed in the AC close to the iris, farthest
GDI can be done based on the surgeons’ prefer- from the graft. Sulcus placements are however
ence. But in cases with associated ocular mor- preferred if the eye is pseudophakic. GDIs can
bidities like extensive peripheral anterior be placed at the same time as in PKP or after
synechiae, aphakia/pseudophakia, and distorted PKP. In case of pars plana placement, along with
ocular anatomy, the chance of a GDI surviving pars plana and core vitrectomy, removal of the
2  Indications of Glaucoma Drainage Implant 9

vitreous skirt in the PP region is extremely desir- 2.1.5 Glaucoma in Aphakia


able to prevent obstruction of the tube. So the and Pseudophakia
latter can be done only if VR support is available
to the surgeon. Pars plana placement was found With the advent of clear corneal phacoemulsifi-
to have better mean IOP reduction at 1 year as cation, both GDI and trabeculectomy can be
compared with placement in the AC (17 vs planned as the initial surgery according to the
12  mmHg) [2]. In situations where a GDI has surgeon’s preference, but in aphakic patients and
failed to control the IOP, a second GDI can be patients with ACIOL, GDI is the preferred treat-
placed in a different quadrant though the risk of ment. Also in cases where extracapsular cataract
corneal decompensation increases with the extraction or manual small incision cataract sur-
increased number of GDIs [4]. Specular count of gery has been done, GDIs are the mainstay sur-
the corneal endothelial cells should be done if gery if the IOP is uncontrolled. In the Tube Versus
the facility exists before and yearly thereafter. In Trabeculectomy Study, in patients who had
any case of GDI placement in eyes with PKP, undergone previous cataract extraction with
multitude causes can lead to graft failure and intraocular lens implantation and/or failed filter-
should be always looked for at every visit. ing surgery, GDI had better control of IOP than
the trabeculectomy group at the end of 5 years
(Fig. 2.5).
2.1.4 Glaucoma Associated In aphakic glaucoma in childhood, trabeculec-
with Keratoprosthesis tomy with MMC successfully controlled IOP
only in 29% [6] to 33% [7]. Yet in another study
About two third of patients undergoing keratopros- [8], there was significant reduction in IOP in both
thesis have glaucoma [5] (Fig. 2.4). These patients the trabeculectomy MMC group (73.3%) and the
have very poor ocular surface precluding trabecu- GDI group (86.7%). However, it has been found
lectomy. The use of GDI has been found to reduce that in treating glaucoma in children less than 2
IOP effectively and is an absolute indication for years, GDIs had a much better control of IOP
GDI in these cases. In one study Ahmed glaucoma than trabeculectomy, 19% ± 7% and 53% ± 12%,
valve (AGV) was shown to have fewer complica- respectively [9].
tions when compared to other GDIs [5].

2.1.6 Iridocorneal Endothelial


Syndrome

Management of glaucoma in ICE syndrome is


challenging. GDIs are the preferred surgery to
manage these cases, but the lumen tip might get
occluded over a period of time as there is contin-
ued proliferation of the ICE membrane. To avoid
the blockage of the tip lumen, the tube should be
left longer than usual, preferably in the sulcus/
pars plana region. The patency of the tube in
case of blockage by the ICE membrane/iris tis-
sue can be retained by perforating with
Nd:YAG.  GDIs have been reported to success-
fully control IOP in about 70% at 1 year and
Fig 2.4  Uncontrolled IOP in an eye with Boston K-Pro 53% at 5 years [10].
10 J. Pegu et al.

Fig 2.5  Uncontrolled IOP in an eye post cataract surgery with conjunctival scarring. The same eye after placing an
AGV in the sulcus in the supero-temporal quadrant

Fig 2.6  A 12 year old girl s/p lensetcomy and vitrectomy


with IOP of 38 mmHg on MMT

2.1.7 Glaucoma Following


Vitreoretinal Surgery

In secondary glaucoma, following retinal detach-


ment surgery/silicone oil induced (Figs. 2.6 and
2.7), GDI is the mainstay surgery for many rea-
sons if IOP is uncontrolled. GDI can be implanted
even if conjunctiva is scarred due to previous
vitreoretinal surgery, and in any location, unlike
trabeculectomy. In case where the risk of recur-
Fig 2.7  A 22 year old male with silicone oil induced
rent retinal detachment is high and removal of glaucoma. We can see the silicon oil droplets in the AC,
oil is not feasible, GDI can be placed either in large inferior PI, thin sclera and aphakia
infero-­nasal and inferotemporal quadrants.
However, it has been found that the risk of fail-
ure is higher in eyes with silicone oil compared
to eyes not containing oil [11].
2  Indications of Glaucoma Drainage Implant 11

2.2 Management in Pediatric In patients with Sturge-Weber syndrome com-


Glaucoma bined with choroidal hemangioma, the risk of
choroidal effusion and massive hemorrhage is
GDIs play an important role in managing child- high with trabeculectomy [15] where there is a
hood glaucoma refractory to angle surgery and sudden drop in the IOP. In these cases, the best
conventional filtering surgery. In primary con- surgical modality would be an AGV implant
genital glaucoma, where the disorder is only tra- which has a unidirectional valve that prevents
beculodysgenesis, tube implantation is considered postoperative hypotony.
if trabeculectomy has failed and the eye has a
reasonable potential for maintaining vision. In
cases with multiple failed trabeculectomy lead- 2.3 Contraindications of GDI
ing to conjunctival scarring, in advanced glau-
coma with scleral thinning where fashioning of In eyes with a low visual prognosis (hand move-
the trabecular flap may not be possible, tube ment or light perception), cyclodestructive proce-
implantation is the primary procedure of choice. dures may be indicated due to a lower risk of
The potential for serious long-term ocular complications. In cases of very thin sclera, staph-
complications like thin avascular blebs, bleb ylomatous eyes involving >270° of the eye, it will
leaks, and bleb-related infection (7–17%) [12] not be possible to implant a GDI as fixing the
seen with trabeculectomy has always been a con- plate to the underlying thin sclera may cause
cern universally in children who have a long life perforation.
ahead of them. These complications are however In phakic patients with shallow anterior cham-
uncommon with tube implant surgery. ber, GDI should not be implanted due to the risk
Additionally, there are a variety of secondary of corneal touch. In patients who have a flat ante-
glaucomas that have a poor prognosis for the rior chamber with no posterior view, or in eyes
­success of initial goniotomy or trabeculotomy, with total adherent leucoma, GDIs cannot be
such as aniridia, anterior segment dysgenesis, implanted unless combined with a cornea rescue
Sturge-­Weber syndrome, and aphakia. When fur- procedure.
ther intervention is required for these refractory
cases, the options vary according to individual 2.4 Summary
patient factors and surgeon preferences. The sur-
gical alternatives include filtering surgery, Surgeons typically keep GDI as the last reserve
cyclodestructive procedures, and GDIs. After for control of IOP, but the GDI has gained more
GDI surgery, unlike after cyclodestructive proce- popularity with a shift in practice patterns over
dure, ciliary body function is preserved. time as an initial treatment because of dreaded
In buphthalmic eyes with thin sclera, GDI may complications associated with trabeculectomy.
be a safer surgical option compared with MMC tra- The final choice of surgery depends on surgeon
beculectomy. In valved implants, where there is a preference, but when managing high-risk
risk of sudden hypotony, the tube can be ligated ­glaucoma patients, patients likely to need future
with a Vicryl suture in a light fashion so as to let surgery or patient where the follow up is ques-
filtration happen without letting the AC to shallow. tionable, a tube implant procedure is preferred.
Few studies have compared the results of
drainage implants with MMC trabeculectomy. In
one study comparing outcomes of trabeculectomy References
with MMC and GDIs, the success rate was higher
after drainage implant surgery [13], whereas 1. Kwon YH, Taylor JM, Hong S, et  al. Long-term
results of eyes with penetrating keratoplasty and
another study found similar success rates after
glaucoma drainage tube implant. Ophthalmology.
these two procedures [14]. The exact order of 2001;108:272–8.
treatment is dependent on the surgeons’ prefer- 2. Arroyave CP, Scott IU, Fantes FE, et al. Corneal graft
ence and individual patient factors at this time. survival and intraocular pressure control after pen-
12 J. Pegu et al.

etrating keratoplasty and glaucoma drainage device mitimycin C for children in the first two years of life.
implantation. Ophthalmology. 2001;108:1978–85. J Ophthalmol. 2003;136:994–1000.
3. Sidoti PA, Mosny AY, Ritterband DC, et  al. Pars 10. Kim DK, Aslanides IM, Schmidt CM Jr, et  al.

plana tube insertion of glaucoma drainage implants Long-term outcome of aqueous shunt surgery in ten
and penetrating keratoplasty in patients with coexist- patients with iridocorneal endothelial syndrome.
ing glaucoma and corneal disease. Ophthalmology. Ophthalmology. 1999;106:1030–4.
2001;108:1050–8. 11. Ishida K, Ahmed II, Netland PA.  Ahmed glau-

4. Burgoyne JK, WuDunn D, Lakhani V, et al. Outcomes coma valve surgical outcomes in eyes with and
of sequential tube shunts in complicated glaucoma. without silicone oil endotamponade. J Glaucoma.
Ophthalmology. 2000;107:309–14. 2009;18(4):325–30.
5. Netland PA, Terada H, Dohlman CH.  Glaucoma 12. Sidoti PA, Belmonte SJ, Liebmann JM, Ritch

associated with keratoprosthesis. Ophthalmology. R.  Trabeculectomy with mitomycin-C in the treat-
1998;105(4):751–7. ment of pediatric glaucomas. Ophthalmology.
6. Freedman SF, McCormick K, Cox TA.  Mitomycin 2000;107(3):422–9.
C augmented trabeculectomy with post-operative 13. Beck AD, Freedman S, Kammer J, et  al. Aqueous
wound modulation in pediatric glaucoma. J AAPOS. shunt devices compared with trabeculectomy with
1999;3:117–24. mitomycin-C for children in the first two years of life.
7. Blanco R, Wilson R, Spaeth G, et al. Filtration pro- Am J Ophthalmol. 2003;136:994–1000.
cedures supplemented with mitomycin C in the man- 14. Hill R, Ohanesian R, Voskanyan L, et  al. The

agement of childhood glaucoma. B J Ophthalmol. Armenian Eye Care Project: surgical outcomes of
1999;83:151–6. complicated pediatric glaucoma. Br J Ophthalmol.
8. Pakravan M, Homayoon N, Shahin Y, et  al. 2003;87:673–6.
Trabeculectomy with mitomycin C versus Ahmed glau- 15. Iwach AG, Hoskins HD Jr, Hetherington J Jr,

coma implant with mitomycin C for treatment of pedi- Shaffer RN.  Analysis of surgical and medical man-
atric aphakic glaucoma. J Glaucoma. 2007;16:631–6. agement of glaucoma on Sturge-Weber syndrome.
9. Beck AD, Freedman S, Kammer J, et  al. Aqueous Ophthalmology. 1990;97:904–9.
shunt devices compared with trabeculectomy with
The Glaucoma Drainage Devices:
Types and Models 3
Bhumika Sharma, Monica Gandhi,
and Usha Yadava

3.1 Introduction 3.2 Classification

Glaucoma drainage devices are designed to divert The conventional glaucoma drainage devices
aqueous humor from the anterior chamber to the consist of a tube that shunts the aqueous to an end
subconjunctival space. In 1912 the first attempt plate located at the equatorial region. These
was made by Zorab [1] with a silk thread for devices can be further divided into valved or non-­
translimbal aqueous drainage, and subsequently valved implants, depending on whether a valve
attempts were made with gold [2], platinum [3], mechanism is present to restrict the outflow when
and tantalum [4], but the results were poor the IOP becomes too low.
because of uncontrolled flow, hypotony, and for-
eign body inflammatory reaction. Molteno in
1969 introduced the concept of a device that con- 3.2.1 A
 hmed Glaucoma Valve (AGV)
sisted of a long acrylic tube attached to an acrylic (Fig. 3.1)
plate sutured to the sclera adjacent to the limbus,
but this had a high failure rate due to bleb perfo- AGV is a silicone tube connected to a silicone
ration or end plate exposure [5]. In 1973 Molteno sheet valve held in a scarab-shaped end plate of
introduced the concept of draining the aqueous polypropylene (model S2, S3, B1) or silicone
away from the limbus [6], placing the end plate at (model FP8, FP7, FX1). The valve consists of a
the equatorial region, and all of the currently thin silicon elastomer membrane to reduce inter-
available glaucoma drainage devices are based nal friction within the valve system. The AGV
on this concept. consists of a tapered trapezoidal chamber. A
Venturi effect is generated to help aqueous flow
through the device. The velocity of aqueous
entering the larger port of the Venturi chamber
increases significantly as it exits the smaller out-
let port of the tapered chamber. The increased
B. Sharma (*) · U. Yadava exit velocity helps in evacuating the aqueous
Guru Nanak Eye Centre, Maulana Azad Medical from the valve, in effect reducing the valve fric-
College, New Delhi, India tion. The valve is designed to restrict the outflow
M. Gandhi when intraocular pressure is less than 8  mmHg
Anterior Segment and Glaucoma Services, [7–10]. End plate size of AGV is available from
Department of Ophthalmology, Dr. Shroff’s Charity 96 mm2 (S3, FP8) to 364 mm2 (B1, FX1).
Eye Hospital, New Delhi, India

© Springer Nature Singapore Pte Ltd. 2019 13


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_3
14 B. Sharma et al.

Model FP7
Ahmed® Glaucoma Valve - Flexible Plate

16.0 mm

Tube
Plate/Valve Thickness: Outer Diameter
2.1 mm 0.635 mm Tube
Inner Diameter
0.305 mm

13.0 mm

Tube Length:
25.4 mm

Surface Area: 184.0 mm2

Fig. 3.1  Ahmed glaucoma valve FP7

Table 3.1  Specifications of the commonly used AGV models


Ahmed
glaucoma valve
models FP7 FP8 (pediatric) S2 S3 (pediatric)
Plate material Medical grade Medical grade Medical grade Medical grade
silicone silicone polypropylene polypropylene
Plate thickness 2.1 mm 2.1 mm 1.6 mm 1.6 mm
Plate surface 184.0 mm2 102.0 mm2 184.0 mm2 85.0 mm2
area
Tube material Medical grade Medical grade Medical grade Medical grade
silicone silicone silicone silicone
Tube length 25.4 mm 25.4 mm 25.4 mm 25.4 mm
Tube inner 0.305 mm 0.305 mm 0.305 mm 0.305 mm
diameter
Tube outer 0.635 mm 0.635 mm 0.635 mm 0.635 mm
diameter
Valve material Medical grade Medical grade Medical grade Medical grade
silicone, elastomer silicone, elastomer silicone, elastomer silicone, elastomer
membrane membrane membrane membrane
Valve casing Medical grade Medical grade Medical grade Medical grade
polypropylene polypropylene polypropylene polypropylene

A new model M4 [11] was introduced with a The rate of hypertensive phase was noted to
modification of a porous polyethylene shell. It was be less as compared to other AGV models.
anticipated to reduce encapsulation and provide Further studies and evaluation of the model
better tissue integration, thereby a better IOP con- showed that the outcome and failure rates
trol. Initial studies noticed an effective reduction were not acceptable hence the production of
of IOP in the early postoperative stage, but the fail- the model was discontinued [12] (Tables 3.1
ure rates after 1 year were reported to be high. and 3.2).
3  The Glaucoma Drainage Devices: Types and Models 15

3.2.1.1 Tube Extenders for AGV 3.2.3 Molteno Implant (Fig. 3.2)


In certain cases, the tube may fall short and is
needed to be extended. Model TE tube extender Single-plate Molteno implant is a silicone tube
is available which can be used to extend the attached to 134 mm2 polypropylene end plate. In
existing tube. It has a flange which is sutured to 1981 Molteno introduced the double-plate
the sclera. Molteno (DPM) with a surface area of 274 mm2
with the second end plate attached to the right or
left of the original end plate [14]. The two plates
3.2.2 Krupin Slit Valve in double-plate Molteno implant are connected
by a 10-mm-long silicone tube.
Krupin slit valve consists of a silicone tube with Molteno dual ridge device contains V-shaped
a unidirectional horizontal and vertical slit valve ridge on the surface of end plate. Pressure ridge
at its distal end, attached to a silicone oval disc reduces the risk of postoperative hypotony by
with a surface area of 183 mm2. Alternatively, the restricting initial aqueous drainage to the small
tube may be attached to a #220 silastic band. The primary drainage area until the IOP rises suffi-
opening pressure of the slit valve is designed to ciently to lift the tissues and allow drainage of
be 10–12  mmHg, and the closing pressure is aqueous over the entire plate. The implants are
designed to be 8–10 mmHg [13]. MRI safe (Table 3.3).

Table 3.2 Specifications of the other AGV models


available 3.2.4 Baerveldt Implant (Fig. 3.3)
Other AGV models
Single plate S2, FP7, M4
Baerveldt implant is a silicone tube implant
Double plate B1, FX1 attached to a soft, pliable, barium-impregnated
Silicone plate FP7, FP8, FX1, PC7, PC8 silicone end plate of various sizes (i.e., 250 mm2,
Polypropylene plate S2, S3, BI, M4, PS2, PS3 350 mm2, or 500 mm2). This was introduced by
Size 96 mm2 S3, FP8, PS3, PC8 Baerveldt in 1992 [15, 16]. The end plate has fen-
Size 184 mm2 S2, FP7, PS2, PC7 estrations which allow fibrous septa to develop
Size 364 mm2 B1, FX1 that reduces the movement of the bleb.

Fig. 3.2 Molteno SS Surface Area of Plate = 185 mm2


S-series single-plate
implant

SL Surface Area of Plate = 245 mm2


16 B. Sharma et al.

Table 3.3  Specifications of Molteno implant


Molteno implants Plate Size
Molteno3 S-series SS Single plate 185 mm2
Molteno3 S-series SL Single plate 254 mm2
Molteno3 G-series GS Single plate 175 mm2
Molteno3 G-series GL Single plate 230 mm2
Molteno S1 Single plate 133 mm2
Molteno Pediatric P1 Single plate 80 mm2
Molteno L2 and R2 Double plate 266 mm2
Molteno pressure ridge D1 Single plate 133 mm2
Molteno pressure ridge Double plate 266 mm2
DL DR

Fig. 3.4  Baerveldt glaucoma implant BG 102-350 for


pars plana insertion

cus in a pseudophakic eye or in pars plana in a


vitrectomized eye (Fig. 3.4).
AGV with pars plana clip (PS2, PS3) and
Baerveldt BG 101-350 glaucoma implant are
used as pars plana glaucoma drainage devices.

3.2.6.1 Indications for Pars Plana GDD


• Patients that require shunt surgery and have
undergone (or are expected to need) corneal
Fig. 3.3  Baerveldt BG 101-350 implant transplantation.
• Patients that require shunt surgery and a vitrec-
AADI is a Baerveldt type implant manufac- tomy is otherwise indicated include chronic uve-
tured in India. itis and neovascular glaucoma are the conditions
which require shunt surgery and vitrectomy.

3.2.5 Schocket Implant 3.2.6.2 Advantages of the Pars Plana


Approach
Schocket implant [17] is a silastic tube implant • Pars plana implant does not compromise the
with 0.3  mm internal diameter. One end of the cornea.
tube is inserted into the AC, and the other end is • Risk of retraction of the tube is less with pars
tucked beneath the groove portion of # 20 retinal plana approach.
encircling band attached 360° around the globe • Accurate positioning is less important with a
near the equator under the recti muscles. pars plana device compared with an anterior
chamber implant.

3.2.6 P
 ars Plana Glaucoma
Drainage Devices 3.3 Summary

The tube of the glaucoma drainage implant is The conventional glaucoma drainage devices
most commonly placed in the anterior chamber. shunt the aqueous from the anterior chamber to
However, the tube may also be placed in the sul- the subconjunctival space and thereby help in
3  The Glaucoma Drainage Devices: Types and Models 17

maintain the IOP.  Various models are available, Ahmed Glaucoma Valve implant. Am J Ophthalmol.
1999;127:27–33.
and they are chosen in accordance with the 10. Topouzis F, Coleman AL, Choplin N, et al. Follow-up
patient and disease profile. Newer devices are of the original cohort with the Ahmed glaucoma valve
discussed in a separate chapter. implant. Am J Ophthalmol. 1999;128:198–204.
11. Cvintal V, Moster MR, Shyu AP, McDermott K, Ekici
F, Pro MJ, Waisbourd M. Initial experience with the
new Ahmed glaucoma valve model M 4: short-term
References results. J Glaucoma. 2016;25(5):e475–80.
12. Sluch I, Gudgel B, Dvorak J, Anne Ahluwalia M,
1. Zorab A.  The reduction of tension in chronic glau- Ding K, Vold S, Sarkisian S.  Clinical experience
coma. Ophthalmoscope. 1912;10:258–68. with the M4 Ahmed Glaucoma drainage implant. J
2. Stefansson J.  An operation for glaucoma. Am J Curr Glaucoma Pract. 2017;11(3):92–6.. Epub 2017
Ophthalmol. 1925;8:681–92. Oct 27
3. Muldoon WE, Ripple PH, Wilder HC.  Platinum 13. The Krupin Eye Valve Filtering Surgery Study Group.
implant in glaucoma surgery. Arch Ophthalmol. Krupin eye valve with disk for filtration surgery.
1951;45:666. Ophthalmology. 1994;101:651–8.
4. Tronsco MU. Use of tantalum implants for inducing a 14. Airaksinen PJ, Aisala P, Tuulonen A. Molteno implant
permanent hypotony in rabbit eyes. Am J Ophthalmol. surgery in uncontrolled glaucoma. Acta Ophthalmol.
1949;32:499–508. 1990;68:690–4.
5. Molteno ACB. New implant for draining in glaucoma. 15. Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer
Br J Ophthalmol. 1969;53:609. DK, Baerveldt G, et al. Randomized clinical trial of
6. Molteno AC, Straughan JL, Ancker E, et al. Long tube the 350-mm2 versus the 500-mm2 Baerveldt implant:
implants in the management of glaucoma. S Afr Med longer term results: is bigger better? Ophthalmology.
J. 1976;50:1062–6. 1999;106:2312–8.
7. Ayyala RS, Zurakowski D, Smith JA, et  al. A 16. Hodkin MJ, Goldblatt WS, Burgoyne CF, Ball

clinical study of the Ahmed glaucoma valve SF, Insler MS.  Early clinical experience with the
implant in advanced glaucoma. Ophthalmology. Baerveldt implant in complicated glaucomas. Am J
1998;105:1968–76. Ophthalmol. 1995;120:32–40.
8. Coleman AL, Hill R, Wilson MR, et al. Initial clinical 17. Omi CA, De Almieda GV, Cohen R, et al. Modified
experience with the Ahmed Glaucoma Valve implant. schocket implant for refractory glaucoma. Experience
Am J Ophthalmol. 1995;120:23–31. of 55 cases. Ophthalmology. 1991;98(2):211–4.
9. Huang MC, Netland PA, Coleman AL, et  al.
Intermediate-term clinical experience with the
Preparing the Patient
for the Glaucoma Drainage 4
Device Surgery

Parul Ichhpujani

Medical and/or laser treatment are the first line of glaucomas that have failed medical and laser ther-
treatment for most glaucoma patients. However, if apies in addition to one or more surgical proce-
the target intraocular pressure (IOP) is not attained dures such as trabeculectomy [1].
on maximally tolerable medical therapy and glau- In recent years, some surgeons have forgone
comatous damage is still progressing or is deemed standard trabeculectomy surgery and started
likely to progress, then surgery is suggested to the using GDDs or tube shunts as first-line surgery
patient. Usually, the surgeon and the patient are [2, 3].
faced with a dilemma to choose between a trab- Patient must understand that a GDD surgery
eculectomy and a glaucoma drainage device. will not result in improvement in vision; rather
Patients scheduled for any surgery are appre- the chief reason for performing the procedure is
hensive and have lots of queries. Clinicians can preventive as without it, vision is likely to dete-
enhance patient preparation by explaining the riorate or, in rare cases, be totally lost. For most
need for the suggested surgery, available alterna- patients, the benefits of the surgery outweigh the
tives and what to expect from the surgery and risks, but this has to be evaluated separately for
reinforcing instructions as regards preoperative each patient.
fasting (especially in cases undergoing general
anaesthesia and for diabetics), medications (e.g.
aspirin, oral hypoglycaemics, antihypertensives), 4.2  hat Are the Alternatives
W
anaesthesia and postoperative care. to Glaucoma Drainage
Device Surgery?

4.1  hat Are the Indications


W Trabeculectomy: If prior trabeculectomy has not
for Glaucoma Drainage been performed, then trabeculectomy may be
Device (GDD) Surgery? considered as an option.
The Tube Versus Trabeculectomy (TVT)
Glaucoma drainage devices or tube shunts are Study has shown that both the procedures
employed as a surgical procedure to control IOP in resulted in a significant reduction in IOP that
primary or secondary, open-angle or angle-­closure was sustained even at the 5-year follow-up, with
a significant reduction in the use of supplemen-
P. Ichhpujani (*) tal antiglaucoma medicines in both the groups.
Glaucoma Service, Department of Ophthalmology,
Government Medical College and Hospital,
Early postoperative complications were more
Chandigarh, India frequent in the trabeculectomy group, though

© Springer Nature Singapore Pte Ltd. 2019 19


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_4
20 P. Ichhpujani

most were transient and self-limited. Late post- These GDDs do not have a restrictive valve
operative complications, resurgery for compli- device within them; hence, these need to be tied
cations, cataract extractions and vision loss off (rip cord suture) at the time of surgery.
were not statistically different between the two Depending on the type of suture used, the liga-
groups [3]. ture often spontaneously dissolves at around
Cyclodestructive procedures: Cyclodestruction 6 weeks to allow flow from the tube to the plate.
using cryotherapy is associated with vision- Some surgeons prefer a stent to block the tube,
threatening complications and hence is no longer which when removed makes the GDD functional.
considered a preferred option. Usually by 6 weeks, a thick capsule forms around
Cyclodestruction by diode laser cyclophoto- the plate. Therefore, when aqueous passes
coagulation (DLCP) is an option in refractory through the tube, and to the plate, the capsule
cases with poor functional vision. It is achieved provides some resistance and helps prevent the
by transcleral application of infrared light, which IOP from being too low.
is mainly absorbed at the site of aqueous produc- Data from the Ahmed Versus Baerveldt (AVB)
tion, pigmented epithelial cells of the ciliary Study and the Ahmed Baerveldt Comparison
body resulting in the destruction of ciliary body (ABC) Study suggests that there are pros and
epithelium and coagulation necrosis of ciliary cons to these two most commonly used GDDs
body stroma. [4, 5].
Immediate and late complications of DLCP The choice of device is based on the sur-
include corneal edema, hypotony and, rarely, geon’s skill and expertise and patients’ need.
phthisis bulbi. Some surgeons reserve AGV for refractory
These days endocyclophotocoagulation cases such as neovascular glaucoma or uveitic
(ECP) has emerged as an option for cyclode- angle closure where IOP is markedly elevated
struction under direct visualization. ECP is being and needs to be reduced quickly. But if mod-
used as a stand-alone procedure or in combina- erate pressure can be maintained in the early
tion with phacoemulsification. ECP can be used postoperative period, Baerveldt is a good
in glaucoma patients with good visual potential. option. It has a lower profile than the AGV,
Most surgeons prefer GDDs over cyclode- and the 5-year treatment outcomes in the ABC
structive procedures when patient has functional Study show that IOP is slightly lower in the
central vision (better than 20/100). Baerveldt group [5].

4.3  hich GDD Is Better: Valved


W 4.4  hat Are the Basic
W
or Non-valved? Investigations Required
Prior to Surgery?
Valved drainage implants: These implants can
potentially avoid low IOP/hypotony in the early Preoperative optimization of medical condi-
postoperative period. Ahmed glaucoma valve tions such as diabetes, hypertension and coro-
(AGV) implant is currently the only valved GDD nary disease is mandatory prior to scheduling
used. the patient for a planned surgery. As a routine
Non-valved drainage implants: Baerveldt preoperative procedure, basic investigations that
drainage implant and Molteno drainage implant are carried out include haemoglobin, coagulo-
are two commonly used non-valved GDDs across gram, blood sugar, routine urine examination,
the globe. India also has a cheaper alternative by ­electrocardiogram, etc. These help to identify
the name of AADI (Aurolab aqueous drainage undiagnosed systemic conditions requiring
implant). attention prior to surgery.
4  Preparing the Patient for the Glaucoma Drainage Device Surgery 21

4.5  hich Drugs Should


W function after surgery. Shield is also advised at
Be Continued or bedtime to prevent pressure over the globe.
Discontinued Prior The postoperative eye drops usually consist of
to Surgery? an antibiotic and steroid eye drop. Initially, the
steroids need to be used intensively (about six
Prior to undergoing GDD surgery, all topical and times daily) and the antibiotic four times daily. In
systemic medications must be continued up until case of frequent instillation, the drops are usually
the morning of the surgery. intended to be instilled during the day (waking
Blood-thinning medications such as aspirin, hours) only. If overnight intensive use is intended,
warfarin and clopidogrel should be discontinued then the patient must be instructed specifically.
at least 1 week before the surgery, to reduce the Topical medications for the unoperated eye must
risk of any bleeding inside the eye. Patients who be continued unless advised otherwise.
are taking warfarin are advised to have their level Patients are seen on the first postoperative day
(INR) checked in the week prior to surgery to and then once a week for the first 4  weeks and
ensure it is within their usual treatment range. may be seen more frequently if the IOP is either
These may be restarted 3  days after surgery elevated or too low or bleb is showing signs of
(unless otherwise stated). The prescribing clini- impending failure.
cian must be consulted to be sure if it is safe to The postoperative eye drops need to be taken
discontinue these medications or switch to an for 1 or 2 months.
alternative medication, especially if the patient
has a history of recent heart valve replacement or
4.8  hat Are the Possible Risks
W
other serious condition that may need to be taken
and/or Complications?
into consideration. These patients can be oper-
ated under monitored anaesthesia care (MAC).
Majority of tube shunt procedures are successful
and relatively halt the glaucoma progression to
blindness. Nonetheless, it is important to under-
4.6  hat Type of Anaesthesia Is
W stand the possible risks and complications associ-
Given for a GDD Surgery? ated with GDDs. Any of the complications listed
underneath can occur even with the best surgical
Most cases can be operated under the effect of
techniques. Most of the complications are short-­
peribulbar anaesthesia, with or without a mild
lived or can be conservatively or surgically man-
sedative. In special circumstances, general anaes-
aged, while serious complications are much more
thesia may be preferable. General anaesthesia is
rare. The principal long-term complication of an
also preferable for patients who are claustropho-
anterior chamber GDD is corneal endothelial
bic or have back or breathing problems. The sur-
decompensation. Other common postoperative
gical procedure usually lasts about an hour and a
issues include:
half.
• Transient hypotony: This usually results due
to leak around the tube in limbal tissues or
4.7 What to Expect failure of flow-restricting devices to maintain
in the Postoperative Period? sufficient resistance.
• Postoperative hypertensive phase: This is usu-
The eye is patched after the surgery, and the patch ally seen 2–3  weeks post surgery. IOP
is removed the following day. If the unoperated increases due to inflammation induced by flow
eye has poor vision, then the operated eye is not of aqueous humour around the explant, neces-
patched with a cotton pad. Instead, a clear shield sitating resumption of topical antiglaucoma
is placed on the operated eye so that patient can medications.
22 P. Ichhpujani

Uncommon or rare complications include: must refrain from all forms of exertion until
the pressure is restored. Preferably the patient
• Choroidal detachment. should wear an eye shield during sleep for the
• Intraocular bleed. first postoperative week.
• Infection: With a GDD surgery, infection can • While praying, patients may kneel but should
occur months to years after the surgery and refrain from bowing the head down to the
may sometimes necessitate GDD removal. floor in the first 2  weeks. Yoga asanas that
Postoperative instructions usually address in require head-down posturing should also be
detail how to prevent late infections. avoided.
• Diplopia: Seen with larger GDDs such as • It is important to avoid strenuous activity and
Baerveldt. sports such as swimming, jogging and contact
• Tube-related complications: Tube-cornea sports, during the early postoperative period.
touch, tube extrusion and tube exposure. It is recommended to commence strenuous
activity only after consulting with the con-
cerned surgeon.
4.9  hat Is the Success Rate
W • It is safe to fly after surgery, but it is best not
of GDD Surgery? too travel in the first 2 weeks after surgery as
frequent follow-up visits may be scheduled in
• With GDDs such as the Baerveldt, the this period.
expected success rate over 5 years is as high as • If a patient wears contact lenses, it is possible
70% and 80% [4, 5]. Although a significant to start wearing them again about 4–5 weeks
proportion of patients achieve adequate IOP after surgery and sometimes sooner.
control without the need for antiglaucoma
medications, many may still require one or
two medications to assist the shunt in control- 4.11 W
 hen Can the Patient
ling the IOP. Resume Work?
• Any GDD surgery may fail over a period of
time, due to the natural wound healing tenden- The duration of time off work depends on a num-
cies of the eye. The body reacts to the GDD as ber of factors such as the nature of job, vision in
a “foreign object” and results in fibrosis and the other eye and/or any postoperative complica-
scarring around the plate of the GDD.  As a tions. Typically, a patient working in an office
result, glaucoma medications may need to be environment can resume work in 2  weeks. If
resumed or stepped up to lower the elevated work entails heavy labour/weight lifting, or a
IOP. Additionally, sometimes a repeat surgery dusty environment, then longer rest is needed.
may be required. On the flip side, non-valved
GDDs may cause hypotony, which may result
in vision impairment and thus may require a 4.12 W
 hat Are the Chances
revision procedure. of Infection with the Donor
Tissue Used as a Patch Over
the Tube of GDD?
4.10 W
 hich Day-to-Day Activities
Can Be Carried Out After • The donor tissues used in GDD surgery are
a GDD Surgery? not live transplants. Donors are tested prior to
receiving the tissue for infectious diseases
• Watching television, using a computer and such as HIV, hepatitis B and C and syphilis.
reading can be continued without worry. If the • They are not tested for prion disease as no
intraocular pressure is very low, then patient suitable test exists. The risk of transmission of
4  Preparing the Patient for the Glaucoma Drainage Device Surgery 23

prion disease has been documented to be References


extremely low.
• In the United Kingdom, after receiving donor 1. Hong CH, Arosemena A, Zurakowski D, et  al.
Glaucoma drainage devices: a systematic literature
tissue, patients no longer remain eligible to review and current controversies. Surv Ophthalmol.
donate blood. 2005;50:48–60.
2. Gedde SJ, Schiffman JC, Feuer WJ, et al. The Tube
Versus Trabeculectomy Study: design and baseline
characteristics of the study patients. Am J Ophthalmol.
4.13 A
 re the GDDs Safe for MRI 2005;140:275–87.
Scanning? 3. Gedde SJ, Schiffman JC, Feuer WJ, et al. Treatment
outcomes in the Tube Versus Trabeculectomy (TVT)
AGV does not show up on an X-ray but is visible Study after five years of follow-up. Am J Ophthalmol.
2012;153(5):789–803.
on a CT scan and MRI images. The Baerveldt 4. Christakis PG, Tsai JC, Kalenak JW, Zurakowski D,
implant is “radiopaque” (Barium impregnated) Cantor LB, Kammer JA, Ahmed II. The Ahmed ver-
and shows up on all three imaging studies. sus Baerveldt study: three-year treatment outcomes.
Neither of these implants have any metal in them; Ophthalmology. 2013;120(11):2232–40.
5. Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman
therefore they both are safe for use with MRI J, Costa VP, Godfrey DG, Buys YM, Ahmed Baerveldt
scanning. Comparison Study Group. Five-year treatment out-
One size does not fit all. Ultimately, “to trab comes in the Ahmed Baerveldt comparison study.
or to tube” is the surgeon’s decision, but a well-­ Ophthalmology. 2015;122(2):308–16.
informed patient will be more prepared and
have realistic expectations from the surgery
performed.
The Ideal Glaucoma Drainage
Device: Which One to Choose? 5
Purvi Bhagat

5.1 Introduction an IOP regulating valve. The conventional ones


are the Molteno, Krupin, Baerveldt, Ahmed glau-
The number of available surgical options for coma valve (AGV), and Aurolab aqueous drain-
managing glaucoma is on the rise. Innovations in age implant (AADI).
technology not only offer greater hope to patients There are also newer devices like the Ex-Press
but also force the surgeons to make difficult ther- mini shunt, Glaukos iStent, OptiMed Glaucoma
apeutic decisions. The surgeons must critically Pressure Regulator, and gold micro shunt. These
evaluate each individual case and treatment are positioned in the anterior chamber angle from
options to determine which surgical measure where they either drain the aqueous into the
would finally be the most appropriate. Schlemm’s canal, subconjunctival space, or the
After the first glaucoma drainage device suprachoroidal space.
(GDD), i.e., the Molteno implant, was intro-
duced, various modifications in design and Fluid exits the eye onto
plate
improvements in surgical techniques have
occurred leading to greater success with better Cornea Iris Tube Plate
pressure control, easier implantation, and fewer
complications [1].
With implantation of a GDD into the episcleral
space and placement of its silicone tube either into
the anterior chamber or pars plana, the aqueous
humor is drained from the eye under the Tenon’s
capsule and conjunctiva, leading the fluid to the
base plate. Placed near the equator of the eye, this
plate leads to a cyst formation that provides resis-
tance to fluid transport, ultimately leading to reduc-
tion of intraocular pressure (IOP) (Fig. 5.1) [2].
Currently, the GDD are available in various
sizes, materials, and designs and with or without

P. Bhagat (*)
M & J Western Regional Institute of Ophthalmology,
B. J. Medical College and Civil Hospital,
Ahmedabad, India Fig. 5.1  Principle of a glaucoma drainage device

© Springer Nature Singapore Pte Ltd. 2019 25


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_5
26 P. Bhagat

Table 5.1  Glaucoma drainage devices [1, 3]


Type Size Material
Valved implants
•  Ahmed implant
 Single plate 184 mm2 Polypropylene/silicone
  Pediatric size 96 mm2 Polypropylene/silicone
  Double plate 364 mm2 Polypropylene/silicone
  Pars plana 184 mm2 Polypropylene/silicone
  Pars plana (pediatric) 96 mm2 Polypropylene/silicone
•  Krupin slit valve 183 mm2 Silastic
• OptiMed 140 mm2 Silicon + polymethylmethacrylate
Non-valved implants
• Baerveldt
  Single plate 250/350 mm2 Silicone
  Pars plana 350 mm2 Silicone
•  Eagle vision 365 mm2 Silicone
• Molteno
  Single plate 137 mm2 Polypropylene
  For microphthalmos 50 mm2 Polypropylene
  Double plate 274 mm2 Polypropylene
  Molteno 3/single plate 175 mm2 Polypropylene
  Molteno 3/double plate 230 mm2 Polypropylene
•  Aurolab aqueous drainage implant (AADI) 350 mm2 Silicone

The drainage devices most frequently used are retrospective and nonrandomized and have com-
the AGV, AADI, and Ex-Press (Table 5.1). pared different device models in different patient
With the gradual increase in the use of these populations using different criteria for success
implants, it is important to be aware of their merits and for variable follow-ups [3].
and demerits so that the most appropriate can be
selected for a given case. Unfortunately, there is • An important conclusion to be remembered
inadequate evidence suggesting that one particular from the study of Mills et al. was that a 10%
shunt is the best choice for a specified given diag- failure rate existed per postoperative year in a
nosis [4]. However, some guidelines maybe series including long-term follow-up for sin-
formed that maybe useful in selecting one implant gle- and double-plate Molteno tubes.
over another. These guidelines are based on vari- Extrapolating the data, it seems that most
ous comparative studies done on different devices GDDs have a functional life span of less than
and aim to answer the following questions: 5 years before they fail from fibrous encapsu-
lation [5].
1. Do all the glaucoma drainage implants lower • A meta-analysis of 147 studies published
the pressure equally? between 1966 and 2002 was carried out by
2. Do larger implants lower the IOP more than Hong et  al. [5]. Fifty-four articles were
smaller ones? included in the final analysis (29 with Molteno,
3. Does the design of the implant influence the single and double plate with some intraopera-
complications? tive modification to prevent hypotony, with
4. Do indications for various devices differ? single-plate Molteno without any surgical
modification, 9 with Baerveldt, 8 with AGV,
and 2 with Krupin). It was concluded that all
5.2 Comparison of Glaucoma the five implants significantly lowered IOP
Drainage Devices but there was no statistically significant differ-
ence between the percentage change in pres-
Although the drainage implants are used so very sures and in the overall surgical success
frequently, almost all comparisons have been between devices. It was also found that a
5  The Ideal Glaucoma Drainage Device: Which One to Choose? 27

larger end plate does not lower the IOP more group and hypertensive crisis in the valved
than standard single plates when followed for group [12].
more than a year [1, 6].
All these studies indicate that size of the
implant does matter, but to a limited extent. As a
5.2.1 Comparison of Plate Size general rule, the bigger the implant plate, the
greater will be the risk of hypotony.
Plate size of various implants has also been ana- Non-valved tubes are now temporarily tied off
lyzed and compared to understand whether it has during implantation leading to little difference in
any influence on the final IOP. rates of immediate postoperative hypotony
between valved and non-valved glaucoma drain-
• A randomized controlled trial involving 132 age devices [13].
patients showed a higher success rate in the
double-plate (270 mm2) Molteno group com-
pared to the single-plate (135 mm2) Molteno 5.2.2 Comparison of Plate Material
group [3].
• The study by Heuer et  al. also showed Plate material has also been studied to assess its
improved IOP control with the Molteno dou- influence on IOP control, as it may affect the tis-
ble plate compared to the single plate in a pro- sue reaction and degree of bleb encapsulation.
spective study of aphakic and pseudophakic Elastomeric silicone (polydimethylsiloxane)
glaucoma [1, 7]. is the most commonly used material in current
• In a prospective study by Lloyd et al. compar- GDDs. Silicone, polymethylmethacrylate, and
ing 350 mm2 and 500 mm2 Baerveldt implants, other hydrophobic polymers have a relatively
statistically comparable results were reported higher binding affinity for plasma and interstitial
as regards IOP control, visual acuity, and fluid proteins. These proteins get adsorbed within
complications [3, 8]. minutes of implantation leading to cellular adhe-
• In another similar prospective study compar- sion, cytokine release, and inflammation. Chronic
ing 350 mm2 and 500 mm2 Baerveldt implants, low-grade inflammation is further exacerbated by
Britt et al. found better IOP control with the microscopic shearing of the implant relative to
350 mm2 implant than with the 500 mm2 [9]. the surrounding tissues [3].
• Although fewer IOP-lowering agents were
required in patients with 500 mm2 implants to • Ayyala et al. reported more inflammation with
achieve target IOP, some complications also polypropylene variety (Molteno) than with
occurred more frequently with this size. A silicone (Krupin implant) when inserted sub-
larger filtration area would appear to improve conjunctivally in rabbits [14, 15].
filtration, but the eventual subconjunctival • Retrospective studies comparing AGV sili-
fibrosis over a wider area may also have an cone and polypropylene models reported sim-
adverse influence [3]. ilar results with both in terms of IOP control,
• A study comparing Baerveldt glaucoma final visual acuity, and postoperative use of
implants (BGI) with end plate sizes of antiglaucoma medications [16, 17]. In one of
250  mm2 and 350  mm2 concluded that there these studies, the silicone implant was associ-
was no difference in surgical success, IOP, ated with fewer serious complications [16].
vision, or topical medications through 3 years • In a prospective, multicentric, comparative
[3, 10]. series, wherein the AGV silicone and polypro-
• In another retrospective study, double-plate pylene material were investigated, improved
Molteno showed a lower mean IOP com- IOP control was seen with the silicone model
pared to single-plate AGV at 24  months [1, compared to polypropylene. Tenon’s cysts
11]. The study also reported a high incidence were observed more in the polypropylene
of postoperative hypotony in the non-valved group [18].
28 P. Bhagat

Late postoperative hypotony caused by “over- • The Ahmed Baerveldt Comparison (ABC)
filtration” can be managed by removing part of study, a multicentric, randomized, prospective
the plate in cases of silicone implant. This is not trial wherein 276 patients with uncontrolled
possible with Molteno or older AGVs made of glaucoma received either an AGV (model
rigid polypropylene material that cannot be cut FP7) or a Baerveldt implant (model 350 mm2),
easily. reported that 1  year postoperative, the
In summary, polypropylene end plates are Baerveldt group had a lower IOP than the
more inflammatory than silicone. The inflamma- Ahmed group (13.2 vs. 15.4  mmHg), had
tion may be due to the biomaterial itself, rigidity, lesser additional surgeries required, and used
flexibility, and shape of the end plate [15]. lesser glaucoma medications (1.5 vs. 1.8). The
incidence of early and serious postoperative
complications, however, was more common in
5.2.3 Comparison of Plate Design the Baerveldt group [23, 24].
• In another study, devastating hypotony-related
The design of the implant is also said to have an complications occurred only in Baerveldt
influence on the rate and type of complications. implanted eyes resulting in poor visual out-
Ocular motility problems usually occur with larger comes. Bleb encapsulation was significantly
plates but are not uncommon with smaller ones. more common in the Ahmed group (11% vs.
Diplopia has been noted more with Baerveldt 3%). Interventions were needed significantly
implants than with AGV or Molteno implant [1]. more often in Baerveldt eyes than the Ahmed
This extraocular muscle imbalance results mainly valve eyes (47% vs. 32%) [25].
due to the mass effect of the plate and surround- • Barton et al. concluded that the Ahmed valve
ing bleb on the neighboring extraocular muscles offers improved predictability of early control,
and due to the implant “wings” located beneath while the Baerveldt implant has a lower rate of
the muscles. long-term excessive encapsulation [26, 27].
Other aqueous shunts appear to have an inci- • Budenz et al. found no difference between the
dence of diplopia in the range of 2–7% [13]. success rates of the Ahmed and the Baerveldt
system after 1 year of follow-up [24, 28].

5.2.4 Comparison of AGV


and Baerveldt Device 5.2.5 Comparison of Cost

• A few retrospective studies have compared the Another important consequence of a tube surgery
AGV and Baerveldt implants. One series con- which is of concern and has to be borne in mind
sisting of 118 eyes and followed up for is the cost of post-surgery glaucoma medications.
48 months found that the final success in terms Because the Baerveldt and its prototypes are non-­
of IOP control was comparable in both groups. valved devices, enough pressure control is not
Hypotony-related complications were seen obtained until the tube ligation suture dissolves.
more in the Baerveldt group, and hypertensive So during this period, there is a need for glau-
crisis requiring antiglaucoma medications was coma medications to control the IOP.  Using an
more in the Ahmed group [19–21]. Ahmed valve might eliminate this extra cost [29].
• The Ahmed Versus Baerveldt (AVB) study
evaluated 238 patients with uncontrolled
refractory glaucoma. The Baerveldt group had 5.3 Selection of the Shunt
a lower IOP than the Ahmed group (13.6 vs.
16.5  mmHg) at the end of 1  year and used The decision to choose a specific device depends
fewer glaucoma medications (1.2 vs. 1.6) but on the patient’s disease characteristics like type
required more postoperative surgical interven- of glaucoma, preoperative IOP, optic nerve dam-
tions [22, 23]. age, and target IOP. It also depends on patient’s
5  The Ideal Glaucoma Drainage Device: Which One to Choose? 29

age and compliance and the surgeon’s personal Early IOP control is determined by the
comfort and choice. presence or absence of valve in an implant.
The general guidelines which may be consid- Valved implants provide more immediate IOP
ered during decision-making are: control and a lower rate of hypotony.
Long-term IOP control depends on the sur-
1. For a novice surgeon, valved devices may be face area of the implant, which determines the
preferred as the surgical technique is simpler bleb size, tissue response to implant, and thick-
involving one quadrant and without manipula- ness of the fibrous capsule which controls the
tion of muscles. IOP control in the early post- aqueous flow through the bleb wall [32–34].
operative period is also more predictable with If the postoperative target IOP is relatively
the flow-restricting mechanism. Postoperative higher, one might choose an Ahmed valve
care is simplified with minimal risk of hypot- because the risk to the patient is less.
ony and choroidal effusion. If the patient is younger, with concerns
2. The valved shunts are highly effective for eyes about healing and bleb encapsulation, then the
that need a low IOP quickly, such as in cases choice would be a Baerveldt type.
of advanced open-angle glaucoma, uveitic If a patient is elderly with a failed trabecu-
glaucoma, and neovascular glaucoma. If an lectomy, the choice would be an Ahmed for
eye can tolerate a higher IOP for few weeks safety reasons and considering the life expec-
even after surgery, then a Baerveldt type tancy of the patient.
implant may be considered. If a patient has had a failed trabeculectomy,
3. In patients showing poor compliance with
followed by interventions and finally a failed
drug use and follow-ups, valved implants may filter, and the conjunctiva is unhealthy, a
be preferred which usually require less post- Baerveldt type should be considered [30].
operative follow-up and care. Because the 9. Implant size: The ideal size of the end plate is
tube in non-valved devices is occluded during unknown, and research shows conflicting data
the initial 4–6 weeks, it often requires added [35]. There is also no current evidence to sug-
interventions, medicines, and follow-ups [30]. gest that when a larger plate is needed, which
4. In patients with high risk of suprachoroidal is better, single large plate or double plates [4]?
hemorrhage, including those with aphakia, Advantage of single plate: Ease of
previous vitrectomy, uncontrolled blood pres- insertion.
sure, or very high preoperative IOP and who Advantages of double plate: Egress of aque-
use anticoagulants, valved implants maybe ous to either plate can be controlled by ligating
safer because of the reduced risk of IOP fluc- the connecting tube, thus independently con-
tuations [31]. trolling the flow of aqueous to each plate.
5. The non-valved type may be preferable if an Disadvantages of single plate: There is no
Ahmed device has already failed in the eye [23]. role of individual ligation. Larger plates are
6. Although the Baerveldt types may provide
also more prone to hypotony and its related
lower long-term pressures, there are pressure complications.
instabilities in the early postoperative period Disadvantages of double-plate implants:
that may not be acceptable to patients with These include difficulty of insertion, and if
severe disease. they fail, the upper quadrants are unavailable
7. The amount of conjunctival scarring may also for future reuse.
determine the size of the implant and available The use of smaller surface implants may
area for a single-plate versus double-plate achieve similar IOP lowering effect and with
device. the added advantage of fewer complications,
8. The most important factor influencing the
and with preservation of one of the upper
selection of implant is the target IOP, both in quadrants for further repeat glaucoma surgery,
the short term and long term. if needed.
30 P. Bhagat

5.4 Tubes Versus Ex-Press Shunt postoperative shallow anterior chamber and
aqueous misdirection occur more commonly.
5.4.1 Indications for Tubes [36, 37] • Patients who did poorly in the other eye with a
prior trabeculectomy and did well with a sub-
• Very high baseline IOP with a relatively higher sequent tube shunt.
postoperative target IOP. • Patients with severe dry eye disease who
• Steroid response glaucoma—This condition might not tolerate an anterior bleb and possi-
usually presents with very high IOP but is bly have bleb dysesthesia.
often also short lived. A tube shunt can control • Patients who wish to continue wearing contact
the IOP during the required period, and the lenses postoperatively.
spike resolves by the time the tube shunt • Patient preference.
enters the hypertensive phase.
• Absence of healthy superior bulbar conjunc-
tiva for an Ex-Press shunt or a 5.4.2 I ndications for Ex-Press Shunt
trabeculectomy. [38, 39]
• Patients who are not likely to comply with vis-
its either due to distance issues or due to lack 1. Sturge-Weber syndrome—Since choroidal

of support system to help with visits and post- effusions are common in these patients, Ex-­
operative instructions or due to associated Press offers a safer alternative because of its
co-morbidities. lower rate of prolonged postoperative
• Patients with history of corneal transplant—It hypotony.
is proven that tube shunts placed in anterior 2. Angle recession glaucoma—Because of the
chamber don’t do as well in patients with pen- minimal tissue manipulation and quieter post-
etrating keratoplasty and vice versa. operative course with the Ex-Press.
Unfortunately, the Ex-Press is much less 3. Patients with impaired coagulation or on sys-
likely to succeed in the presence of a shallow temic anticoagulant drugs—Because it avoids
anterior chamber and/or peripheral anterior an iridectomy, which often has associated
synechiae. Trabeculectomy is also highly bleeding.
likely to fail even with adjuvant use of antime- 4. Patients who have an urgent need for faster
tabolites. So tube shunts placed in the pars recovery.
plana are the best choice in these patients. 5.
Patients with very high preoperative
• Patients with blepharospasm, severe squeeze pressures.
reflex, or very poor exposure of the superior
bulbar conjunctiva as in inability to infraduct
the eye, very small palpebral fissure, or promi- 5.4.3 Contraindications for Ex-Press
nent brows wherein bleb care and bleb inter- Shunt [40, 41]
ventions would be extremely difficult.
• Patients with poor visual potential especially 1. Congenital and juvenile glaucoma—The

in cases of uveitic or neovascular glaucoma long-term complications of Ex-Press shunt
where the inflammation is more likely to com- are still not clearly known in these cases, and
plicate the postoperative period. so it is best avoided.
• Monocular patients, especially elderly, 2. Aniridia and anterior segment dysgenesis syn-
unless there is a need for IOP less than drome—Angle structures being abnormal,
12 mmHg. Ex-Press implantation is best avoided.
• Patients with narrow angles or angles closed 3. Phakic primary angle closure glaucoma—

with synechiae—Since a peripheral iridec- Ex-­Press should be implanted in eyes with
tomy is not performed with the Ex-Press primary angle-closure disease only if simulta-
shunt, in phakic patients with narrow angles, neous lens extraction is planned or in aphakic
5  The Ideal Glaucoma Drainage Device: Which One to Choose? 31

or pseudophakic patients. Presence of a shal- minimizing the complications. Careful preopera-


low anterior chamber and a thick lens can end tive screening, proper planning, and a meticulous
up in numerous postoperative complications. surgery can further help to improve the results
4.
Microphthalmos and nanophthalmos— [1]. Selecting a device should always be individ-
because of shallow anterior chamber and ualized, considering the profiles of each device,
smaller and crowded anterior compartment. the surgeon’s own experience, patient’s treatment
5. Pseudophakic glaucoma with the presence of goals, the complete clinical situation, and the
an anterior chamber intraocular lens. economic status of the patient.
6. Neovascular glaucoma—The postoperative

hyphema and blood clots can totally occlude
the Ex-Press implant orifice. Also, severe References
postoperative inflammation may lead to adhe-
sions of the scleral flap impairing filtration. 1. Singh P, Kuldeep K, Tyagi M, Sharma PD, Kumar
Y.  Glaucoma drainage devices. J Clin Ophthalmol
7. Patients with thin sclera. Res. 2013;1:77–82.
2. Thieme H.  Glaucoma drainage devices.
Although the effect of Ex-Press device lasts Ophthalmologe. 2009;106(12):1135–46.
longer, it has to be remembered that it is more 3. Lim KS, Allan BDS, Lloyd AW, et  al. Glaucoma
drainage devices; past, present, and future. Br J
expensive than other treatment options [42]. Ophthalmol. 1998;82:1083–9.
4. Caprioli J, Law SK, Giaconi JAA. Pearls of glaucoma
management. Berlin: Springer; 2010. p. 296.
5.5  urolab Aqueous Drainage
A 5. Mills RP, Reynolds A, Emond MJ, et  al. Long-term
survival of Molteno glaucoma drainage devices.
Implant Ophthalmology. 1996;103:299–305.
6. Hong CH, Arosemena A, Zurakowski D, Ayyala
All modern drainage implants are cost prohibitive RS.  Glaucoma drainage devices: a systematic lit-
to some extent for the general population. The erature review and current controversies. Surv
Ophthalmol. 2005;50:48–60.
AADI is a non-valved Baerveldt 350 type of 7. Heuer DK, Lloyd MA, Abrams DA, Baerveldt G,
device made of silicone elastomer. Manufactured Minckler DS, Lee MB, et  al. Which is better? One
by an Indian company, it is a low-cost alternative or two? A randomized clinical trial of single-plate
which can be of great use in poor communities, in versus double-plate Molteno implantation for glau-
comas in aphakia and pseudophakia. Ophthalmology.
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patients where expense of treatment is a concern. 8. Lloyd MA, Baerveldt G, Fellenbaum PS, et  al.
Intermediate-term results of a randomized clini-
cal trial of the 350 versus the 500 mm2 Baerveldt
implant. Ophthalmology. 1994;101:1456–64.
5.6 Other Shunts 9. Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer
DK, Baerveldt G, et al. Randomized clinical trial of
Other newer shunts are still to be well evaluated the 350-mm2 versus the 500-mm2 Baerveldt implant:
individually and in comparison with other exist- longer term results: is bigger better? Ophthalmology.
1999;106:2312–8.
ing devices before we can comment on their uses. 10. Rodgers CD, Meyer AM, Sherwood MB. Relationship
between Glaucoma drainage device size and intraoc-
ular pressure control: does size matter? J Curr
5.7 Conclusion Glaucoma Pract. 2017;11(1):34.
11. Ayyala RS, Zurakowski D, Monshizadeh R, Hong
CH, Richards D, Layden WE, et  al. Comparison of
There is no high-quality evidence which can sup- double-plate Molteno and Ahmed glaucoma valve
port the statement that one drainage device is bet- in patients with advanced uncontrolled glaucoma.
ter than another for long-term IOP control. Ophthalmic Surg Lasers. 2002;33:94–101.
12. Molteno ACB. New implant for drainage in glaucoma:
Design modifications and improvements in surgi- clinical trial. Br J Ophthalmol. 1969;53:606–15.
cal technique are improving the outcomes and 13. David R. Risks of Glaucoma drainage devices. 2014.
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14.
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et  al. Comparison of different biomaterials for coma: evolving paradigms. Indian J Ophthalmol.
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1999;117:233–6. 28. Theime H. Current status of epibulbar anti-glaucoma
15. Ayyala RS, Michelini-Norris B, Flores A, et  al.
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Comparison of different biomaterials for glau- Int. 2012;109(40):659–64.
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Ophthalmol. 2007;42:227–32. coma. 5th ed. Thorofare, NJ: Slack Inc.; 2013.
17. Brasil MVOM, Rockwood EJ, Smith S. Comparison p. 582–3.
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Ophthalmology. 2006;113:1320–6. 34. Aminlari AE, Scott IU, Aref AA.  Glaucoma drain-
19. Syed HM, Law SK, Nam SH, et  al. Baerveldt-350 age implant surgery—an evidence-based update with
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Surgical Technique
of Implantation: AGV, Limbal 6
Variant

Shibal Bhartiya and Monica Gandhi

6.1 Introduction 6.2 Indications


and Contraindications
Ahmed Glaucoma Valve (AGV) is a drainage
device used for both primary and refractory The Ahmed glaucoma valve may be considered
glauomas. The surgical technique of AGV for glaucomas resistant to maximal medical ther-
implantation is simpler and easier than that apy and in patients with failed glaucoma filtration
for non-valved implants since the implant is surgeries. Valves are first-line procedure of the
limited to one quadrant and does not require following:
manipulation of the recti muscles. Also, since
the AGV is valved, manoeuvres like tube liga- • Post-keratoplasty glaucoma.
tion and/or tube slits are not required. Because • Neovascular glaucoma.
of this the incidence of hypotony in the early • Post-vitreoretinal surgery glaucoma.
postoperative period is less than with non- • Phakic/aphakic glaucoma.
valved implants, and these patients require rel-
atively less postoperative follow-up and care. AGV implantation is contraindicated/consid-
Common complications, as with all restrictive ered high risk in eyes with aniridia and limbal
valve implants, include longer postoperative stem cell deficiency since these patients have a
hypotensive phase, choroidal effusions and flat high risk of tube extrusion.
anterior chambers (Table 6.1). AGV must be used with caution in elderly
patients in whom Tenon’s capsule is ultra-thin,
and in patients with chronic uveitis, where the
risk of chronic hypotony from the inflammation
Electronic Supplementary Material  The online version is higher.
of this chapter (https://doi.org/10.1007/978-981-13-5773-
2_6) contains supplementary material, which is available
to authorized users.
6.3 Surgical Technique
S. Bhartiya
Department of Ophthalmology, Fortis Memorial This surgical technique can be used for all AGV
Research Institute, Gurgaon, India
models (Table  6.1), except for the rarely used
M. Gandhi (*) double-plate AGV.  The technique for the FX1
Anterior Segment and Glaucoma Services,
Department of Ophthalmology, Dr. Shroff’s Charity model is similar to that used for double-plate
Eye Hospital, New Delhi, India non-valved implants in terms of isolation of recti

© Springer Nature Singapore Pte Ltd. 2019 33


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_6
34 S. Bhartiya and M. Gandhi

Table 6.1  Types of AGV


Type Model Size Material
Ahmed glaucoma valve
Single plate S2 184 mm2 Polypropylene
Paediatric size S3 96 mm2 Polypropylene
Double plate B1 364 mm2 Polypropylene
Single plate FP7 184 mm2 Silicone
Paediatric size FP8 96 mm2 Silicone
Double plate FX1 364 mm2 Silicone
Pars plana PS2 184 mm2 Polypropylene
Pars plana (Ped) PS3 96 mm2 Polypropylene
Pars plana PC7 184 mm2 Silicone
Pars plana (Ped) PC8 96 mm2 Silicone
(Source: Table modified from http://eyewiki.aao.org/Glaucoma_Drainage_Devices)

and fixation of plates. It however does not require 6.3.3 Priming the AGV
manoeuvres like tube ligation and/or tube slits.
The AGV is primed at a site away from the surgi-
cal field, by injecting balanced salt solution
6.3.1 Corneal/Limbal Traction (BSS) with a 30G needle through the tube. The
Suture valve is ready for use once BSS is seen coming
out of the valve in a steady stream. Care must be
Following strict surgical asepsis, a corneal trac- taken to not damage the valve mechanism which
tion suture is placed using 8′0 Vicryl on a spatu- is housed within the scleral plate.
lated needle and clamped to the surgical drapes to
provide adequate exposure of the surgical field.
In case the surgeon prefers a limbal traction
6.3.4 Anchoring the Plate
suture, the same is placed after the peritomy.
Some surgeons prefer to use 6.0 silk suture for
The plate is sutured 8–10  mm posteriorly from
the corneal traction. Applying a superior rectus
the limbus in the superotemporal quadrant and
suture depends upon the eye as sometimes it may
6–8 mm posterior to the limbus in the nasal quad-
be considered to provide a wider working field.
rants using preplaced 6-0 Dacron/7-0 silk sutures
or 9-0 monofilament nylon suture. It is advisable
6.3.2 Conjunctival Peritomy to mark the position of the implant on the sclera
using gentian violet.
A 90° fornix-based conjunctival incision is made
in the superotemporal quadrant. Following blunt
dissection to separate the conjunctiva from the 6.3.5 Trimming the Tube
Tenon’s capsule, radial relaxing incisions may be
made if required, to provide adequate surgical The length of the tube within the anterior
exposure. Care must be taken to extend the dis- chamber should be approximately 2  mm. The
section towards the equator. tube is therefore trimmed to the desired length
The superotemporal quadrant is chosen for after the body of the valve is anchored to the
ease of surgical access and a lower incidence of sclera. Care must be taken that tube is cut with
ocular motility disorders. The second choice is the bevel-up. This minimises the risk of tube
the inferonasal quadrant, which is especially pre- occlusion by the iris and also minimises endo-
ferred in cases with silicone oil glaucoma. thelial loss.
6  Surgical Technique of Implantation: AGV, Limbal Variant 35

6.3.6 Anterior Chamber tube, in the shape of a rectangle with a lateral


Paracentesis hinge. The tube is inserted into the AC as
described above, and the flap is then positioned
An anterior chamber paracentesis is then per- over it. The ends of the flap are sutured with
formed superiorly using a 23G needle. Care 9-0/10-0 monofilament nylon. This technique
should be taken to ensure that the AC entry is par- provides better cosmesis than using a donor
allel to the plane of the iris and not placed too patch graft. Its use is however contraindicated
anteriorly or posteriorly. The former can result in in patients with scleral thinning. The tube
endothelial decompensation due to rubbing of the maybe fixed with an “X” suture with 10-0
tube against the cornea, while the latter carries the nylon to reduce its mobility and extrusion.
risk of persistent uveitis due to iris chafing/touch. 2. Scleral trench technique: A partial-thickness
scleral flap is dissected along the course of the
tube, in the shape of a rectangle with a lateral
6.3.7 Tube Insertion hinge. A deeper trench (1 × 9 mm) is then dis-
sected to an approximate depth of 90% of the
The tube is then inserted through the needle track sclera. This tissue is then removed to fashion a
using an inserter or atraumatic forceps. In case deep scleral trench for the tube to nest in. The
the insertion is difficult, the track maybe inflated tube is positioned in the deep scleral trench
with viscoelastic to facilitate tube insertion and and inserted into the AC. The partial-thickness
reformation of the AC. scleral flap is sutured over the tube with 10-0
monofilament nylon, ensuring adequate tam-
ponade. The tube maybe fixed with an X
6.3.8 Scleral Patch Graft suture with 10-0 nylon to reduce its mobility
and extrusion.
The scleral patch graft (or donor pericardium) is 3 . Needle track technique: A bent 23G needle is
trimmed to size and sutured to the sclera so that it used to make the needle track with the bevel-
covers the tube close to the limbus with 9-0/10-0 ­up, starting 4 mm behind the limbus. The nee-
monofilament nylon. dle is initially directed vertically under the
Note: episclera and then made parallel to the iris. As
Pars plana implantation of the AGV: the needle enters the eye, viscoelastic is
Vitrectomy is done, and through the port the tube injected to avoid decompression and to
can be inserted or an AC paracentesis is done decrease the risk of hypotony. The tube is then
3  mm posterior to limbus, and then the tube is inserted through this needle track, which min-
inserted. A pars plana clip can be used to anchor imises lateral tube movements and, theoreti-
the tube and prevent kinking. cally, erosions. This obviates the use of a
scleral graft (donor or partial-thickness flap)
and provides better cosmesis and reduces sur-
6.3.9 Closing the Peritomy gical time. The proponents of the technique
also claim that it minimises the problems
The conjunctival flap is then sutured over the related to tube movements like erosions and
implanted tube shunt using 8′0 Vicryl. Continuous, extrusions.
locking sutures ensure a watertight closure. 4 . 24G needle track: In order to minimise the
chances of a peri-tube leakage and consequent
hypotony, some surgeons prefer to use a 24G
6.4 Alternate Techniques needle for AC paracentesis. This ensures a
snug fit of the needle track around the tube,
1. Scleral flap technique: A partial-thickness resulting in cuffing of the AGV tube at the
scleral flap is dissected along the course of the point of AC entry.
36 S. Bhartiya and M. Gandhi

6.5 Efficacy of AGV due to lower rigidity and micro movement of the
plate [10].
The efficacy of the AGV valve as a treatment The IOP needs to be monitored, and appropri-
option for refractory glaucoma is dependent on ate anti-glaucoma medications are added to man-
the pathology for which it is implanted and the age the hypertensive phase. In a retrospective
time period since the surgery. Different authors study by Ayyala et  al. [11], 82% cases had a
have quoted success rates ranging between 43% hypertensive phase which peaked at 1 month and
and 84% [1–7]. At 1 year the efficacy determined stabilised at 6 months. One-third of the patients
was 78% by Coleman et al. [2] In an Indian study in hypertensive phase required a secondary sur-
by Das et al., the effectivity to control IOP was gery for control. A study evaluated the use of
53% at year 1, and this decreased to 43% by the fixed-dose combination of timolol and dorzol-
second year [3]. It is postulated that a 10% amide when the IOP was more than 10 mmHg,
decrease in efficacy occurs within a year and by and it was found to be better than a stepped
5 years it would be expected that the implant is approach in terms of IOP reduction and hyperten-
effective in 50% of cases only [6, 7]. sive phase frequency [12].

6.5.1 Site of Implantation 6.5.3 A


 djunctive Antifibrotics: MMC
and 5-FU
The preferred site of implantation of the valve is
the superotemporal quadrant as it is covered by the Costa et al. [13] compared the short and interme-
upper lid and safely away from the optic nerve. diate rates of success of AGV implantation with
Inferior placement has been tried, and the IOP MMC.  Their study did not find any significant
control and decrease in requirement for glaucoma difference between the eyes with and without
medications were found to be similar as with the MMC. Similar finding reported by Kurnaz et al.
superior placement [8]. However, the inferior [14] documented MMC to be safe and effective
quadrant placement has higher incidence of post- but not found to improve the chances of surgical
operative complications as the risk of exposure success. Three cases of tube exposure in the
warranting removal, and endophthalmitis is higher. MMC group were noted. In another study the
It is also cosmetically unappealing. Therefore it is patients received intraoperative MMC and post-
recommended that the valve be placed in the infe- operative 5-FU, and good IOP control was
rior quadrant only if there is a contraindication to achieved at 6 years of follow-up [15]. In children
its placement in the superior quadrant. <2 years of age, the use of MMC along with AGV
is not recommended as a decreased survival rate
of success was noted [16].
6.5.2 Hypertensive Phase Two types of MMC applications were com-
pared in a retrospective study [17]. MMC was
A short-lived hypotensive phase may be seen applied by cotton soaked swabs at the implanta-
after the surgery which lasts up to 10 days after tion area for 2–5 min in one group. In the other
which a hypertensive phase is common. It may group, the FP-7 AGV valve plate was covered
occur in the first month due to the congestion of with thin layer of cotton soaked MMC and
the bleb wall around the plate. As the congestion inserted in the sub-Tenon pocket. It was then
decreases and the capsule becomes less dense, removed after 2–5 min and irrigated before put-
the IOP may stabilise [9]. Since AGV is a valved ting it back. In both techniques the MMC was
device, the aqueous shunts soon after surgery, irrigated with 200  ml of balanced saline. The
the various mediators may trigger the inflamma- rationale of this technique was that the cotton
tory reaction. The silicone material of the device swabs often roll up and therefore may not be
may also be responsible for the inflammation very effective. A statistically lesser incidence of
6  Surgical Technique of Implantation: AGV, Limbal Variant 37

encapsulated bleb was noted in the second group. 2. Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-­
The MMC concentration used was 0.25–0.33%, Neumann R, Tam M, Bacharach J, Panek WC. Initial
clinical experience with the Ahmed Glaucoma Valve
and this is lower than that used in other studies implant. Am J Ophthalmol. 1995;120(1):23–31.
and may have biased the results in the favour of 3. Das JC, Chaudhuri Z, Sharma P, Bhomaj S. The Ahmed
the different technique. Also, the incidence of Glaucoma Valve in refractory glaucoma: experiences
flat anterior chamber was higher with the new in Indian eyes. Eye (Lond). 2005;19(2):183–90.
4. Souza C, Tran DH, Loman J, Law SK, Coleman AL,
technique. Caprioli J. Long-term outcomes of Ahmed glaucoma
valve implantation in refractory glaucomas. Am J
Ophthalmol. 2007;144(6):893–900.
5. Papadaki TG, Zacharopoulos IP, Pasquale LR,
6.5.4 AGV and Anti-VEGF Christen WB, Netland PA, Foster CS.  Long-term
results of Ahmed glaucoma valve implantation for uve-
itic glaucoma. Am J Ophthalmol. 2007;144(1):62–9.
In NVG, the use of intravitreal bevacizumab
6. Patel S, Pasquale LR.  Glaucoma drainage devices:
(IVB) has been found to decrease the neovascu- a review of the past, present, and future. Semin
larisation. Subsequent pan retinal photocoagu- Ophthalmol. 2010;25(5–6):265–70.
lation, to ablate the ischemic retina, improves 7. Lai JS, Poon AS, Chua JK, Tham CC, Leung AT, Lam
DS. Efficacy and safety of the Ahmed glaucoma valve
the effectiveness of AGV [18]. The injection is
implant in Chinese eyes with complicated glaucoma.
given 1–2  weeks prior to the implant surgery. Br J Ophthalmol. 2000;84(7):718–21.
Efficacy of 85% in AGV plus IVB and 64.3% in 8. Pakravan M, Yazdani S, Shahabi C, Yaseri M. Superior
AGV alone at 12  months was noted, which versus inferior Ahmed glaucoma valve implantation.
Ophthalmology. 2009;116(2):208–13.
decreased to 80 and 53.6%, respectively, in
9. Nouri-Mahdavi K, Caprioli J. Evaluation of the hyper-
18 months [19]. However, in the meta-analysis tensive phase after insertion of the Ahmed glaucoma
of studies comparing the implantation of AGV valve. Am J Ophthalmol. 2003;136:1001–8.
with and without IVB, it was observed that the 10. Coleman AL, Hill R, Wilson MR, et al. Initial clinical
experience with the Ahmed glaucoma valve implant.
haemorrhagic complications were lesser with
Am J Ophthalmol. 1995;120:23–31.
the anti-VEGF injection but the IOP control was 11. Ayyala RS, Zurakowski D, Smith JA, et  al. A

not very different from the cases where it was clinical study of the Ahmed glaucoma valve
not injected [20]. implant in advanced glaucoma. Ophthalmology.
1998;105:1968–76.
12. Pakravan M, Rad SS, Yazdani S, Ghahari E, Yaseri
M.  Effect of early treatment with aqueous suppres-
sants on Ahmed glaucoma valve implantation out-
6.6 Summary comes. Ophthalmology. 2014;121:1693–8.
13. Costa VP, Azuara-Blanco A, Netland PA, et  al.

Ahmed glaucoma valve is a drainage device Efficacy and safety of adjunctive mitomycin C dur-
which is widely used and is effective in the ing Ahmed Glaucoma Valve implantation: a pro-
spective randomized clinical trial. Ophthalmology.
management of refractory glaucomas. With the 2004;111:1071–6.
success rates and safety profile, it has also been 14. Kurnaz E, Kubaloglu A, Yilmaz Y, et al. The effect of
tried in treatment of primary glaucoma. adjunctive mitomycin C in Ahmed glaucoma valve
Variations in the surgical techniques can be implantation. Eur J Ophthalmol. 2005;15:27–31.
15.
Alvarado JA, Hollander DA, Juster RP, Lee
made in accordance to the clinical profile of the LC. Ahmed valve implantation with adjunctive mito-
patient. mycin C and 5-fluorouracil: long-term outcomes. Am
J Ophthalmol. 2008;146:276–84.
16. Al-Mobarak F, Khan AO. Two-year survival of Ahmed
valve implantation in the first 2 years of life with and
References without intraoperative mitomycin-C. Ophthalmology.
2009;116:1862–5.
1. Budenz DL, Barton K, Feuer WJ, Schiffman J, 17. Zhou M, Wang W, Huang W, Zhang X.  Use of

Costa VP, Godfrey DG, Buys YM, Ahmed Baerveldt Mitomycin C to reduce the incidence of encapsulated
Comparison Study Group. Treatment outcomes in the cysts following ahmed glaucoma valve implantation
Ahmed Baerveldt Comparison Study after 1 year of in refractory glaucoma patients: a new technique.
follow-up. Ophthalmology. 2011;118(3):443–52. BMC Ophthalmol. 2014;14:107.
38 S. Bhartiya and M. Gandhi

18. Eid TM, Radwan A, el-Manawy W, el-Hawary


treatment of neovascular glaucoma. Chin Med J.
I. Intravitreal bevacizumab and aqueous shunting sur- 2013;126(8):1412–7.
gery for neovascular glaucoma: safety and efficacy. 20. Zhou M, Xu X, Zhang X, Sun X. Clinical outcomes of
Can J Ophthalmol. 2009;44(4):451–6. Ahmed Glaucoma valve implantation with or without
19. Zhou MW, Wang W, Huang WB, Chen SD, Li
intravitreal Bevacizumab pretreatment for neovascu-
XY, Gao XB, Zhang XL.  Adjunctive with ver- lar glaucoma: a systematic review and meta-analysis.
sus without intravitreal bevacizumab injection J Glaucoma. 2016;25(7):551–7.
before Ahmed glaucoma valve implantation in the
Pars Plana Ahmed Glaucoma
Valve: Surgical Technique 7
Gowri J. Murthy, Praveen R. Murthy,
and Shaifali Chahar

7.1 Introduction 1. Secondary glaucomas in eyes with disorga-


nized anterior chamber/extensive PAS
Ahmed glaucoma valve (AGV)TM (New World 2. Any secondary glaucoma in an eye with com-
Medical Inc., CA) is a valved glaucoma drainage promised corneal endothelial function
device used in the surgical management of glau- 3.
Post-penetrating keratoplasty secondary
coma. Implantation of the device in the pars plana glaucomas
region, into the vitreous cavity, is a viable man- 4. Any type of secondary glaucoma in a vitrecto-
agement option in eyes with glaucoma which mized eye with scarred conjunctiva around the
have undergone a complete pars plana vitrec- limbus, which precludes anterior placement
tomy. The procedure can help in the control of
intraocular pressure (IOP) in eyes with several The prerequisite for pars plana AGV implan-
intractable secondary glaucomas, where conven- tation is a prior complete pars plana vitrectomy.
tional insertion of the drainage device into the Pars plana vitrectomy can be planned in conjunc-
anterior chamber may not be feasible. tion with the AGV implantation as a combined
procedure as well (Fig. 7.1).

7.2 Indications
7.3 Contraindications
The following are the indications for pars plana
AGV implantation: Pars plana AGV cannot be done in eyes with
intact vitreous gel.
Electronic Supplementary Material  The online version Eyes with extensive anterior hyaloid prolifera-
of this chapter (https://doi.org/10.1007/978-981-13-5773- tion due to neovascularization could be a relative
2_7) contains supplementary material, which is available contraindication.
to authorized users.

G. J. Murthy (*) · S. Chahar


Glaucoma Service, Prabha Eye Clinic and Research
Centre, Bangalore, India
P. R. Murthy
Retina Service, Prabha Eye Clinic and Research
Centre, Bangalore, India

© Springer Nature Singapore Pte Ltd. 2019 39


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_7
40 G. J. Murthy et al.

Fig. 7.1  The device—Ahmed Glaucoma Valve with Pars plana clip—Adult and Pediatric valves

7.4 The Device

The AGV designed for pars plana implantation


comes in two types:

1. Flexible plate with pars plana clip, adult (PC


7) and pediatric (PC 8)™ (New World Medical
Inc., CA)
2. Polypropylene plate with pars plana clip, adult
(PS 2) and pediatric (PS 3)™ (New World
Medical Inc., CA)

The pars plana clip, made of medical grade sili-


cone, is an attachment that redirects the direction of
the tube to insert into the pars plana without bend-
ing or kinking the tube. The clip is fully adjustable
Fig. 7.2  Slit lamp picture of a pars plana AGV seen sub
to be placed anywhere along the tube length. The conjunctival, super temporal quadrant
clip can be sutured to the sclera (Fig. 7.2).
However, the AGV meant for anterior implan-
tation, namely, FP7™ and FP8™, can also be The other features of the device are similar to
implanted into the pars plana region, without the the conventional AGVs for anterior chamber
use of the clip in certain circumstances. implantation.
7  Pars Plana Ahmed Glaucoma Valve: Surgical Technique 41

7.5 Detailed Surgical Steps 4. Priming the valve


A 27 gauge cannula on a syringe filled with
1. Selection of site of insertion BSS is inserted into the lumen of the tube, and
The preferred site for insertion of the device BSS is injected till it flows out through the
is the supero-temporal quadrant. The mobility valve plate. Care should be taken to avoid
of the conjunctiva should be checked preoper- excessive force during the injection as it may
atively, especially in previously operated eyes. damage the valve mechanism.
If it is not feasible, other quadrants, namely, 5. Insertion and suturing of the plate
inferotemporal, superior nasal, and infero- Two 9-0 nylon/8-0 or 7-0 Vicryl sutures are
nasal quadrants, can be used. In the nasal preplaced onto the eyelets in the anterior por-
quadrants, care should be taken as more poste- tion of the AGV plate and tied. The plate is
rior plate positioning can endanger the optic then gently inserted, while hugging the sclera
nerve. Preferably, the distance of the plate with the plate, such that the anterior edge of
from the limbus should be 6–8 mm (Fig. 7.3). the plate is 8–9  mm away from the limbus.
2. Corneal traction suture Once in position, the preplaced sutures tied to
A corneal traction suture (6-0 Vicryl/7-0 the eyelets are anchored to the sclera and
silk) enables rotation of the globe and expo- sutured.
sure of the quadrant where the valve is to be 6. Entry into the eye and insertion of the tube
placed. The pars plana clip is pulled back to an
3. Conjunctival dissection appropriate length such that it lies over the
A fornix-based conjunctival flap is made, pars plana region. The tube is trimmed such
and the incision involves at least 3 clock hours that it is at least 5 mm length into the eye. A
of the conjunctiva at the limbus. Posterior 23 gauge needle can be used to make the entry
back-cuts at the limbus can increase the expo- into the pars plana 3.5 mm from the limbus.
sure obtained. Blunt dissection is carried out The entry should be perpendicular to the
by opening the blades of a curved scissor. sclera with the tip direction toward the center
Care is taken to avoid damage to the extraocu- of the eye. A separate irrigating port can be
lar muscles. Bipolar cautery is used to cauter- used to prevent collapse of the eye. The tube is
ize the bleeders. then inserted into the pars plana entry. The
clip is sutured to the sclera with 9-0 nylon or
7-0 Vicryl sutures (Fig. 7.4).
7. Scleral patch graft: The pars plana clip and the
tube should be covered either with donor
sclera or preserved pericardium patch. This
Pars plana AGV visualised prevents exposure of the tube/clip.
behind iris in aphakic 8. Conjunctival closure: Meticulous conjunctival
eye --------------->
suturing with interrupted stiches using 8-0 or
7-0 Vicryl is recommended. Mattress sutures
are placed at the limbus to prevent exposure of
the patch graft.
9. At the end of the surgery, the tube should be
visualized by indentation from the scleral
side, either through the operating microscope
Fig. 7.3  Slit lamp picture showing the pars plana tube or by indirect ophthalmoscopy.
seen behind the iris in aphakic eye
42 G. J. Murthy et al.

a b

Fig. 7.4 (a, b) Anterior segment photograph after pars plana AGV implantation

7.6 Variations in Surgical


Technique

1. When combining the procedure with pars plana


vitrectomy, the supero-temporal port of the vit-
rectomy itself can be used to insert the tube,
especially when micro-incision ­vitrectomy sur-
gery techniques using 23 gauge vitrectomy are
used. The plate can be sutured prior to com-
mencement of the vitrectomy, and the tube
insertion can be done last, after the vitrectomy
is completed. The pars plana infusion is left in
place till the end of the surgery and removed Fig. 7.5  Anterior segment photo showing massive cho-
roidal hemorrhage with choroidal detachment visualized
only after the tube has been inserted and the behind the iris after AGV implantation
conjunctiva has been sutured (Fig. 7.5).
2. A conventional AGV designed for anterior clip, and increased risk of exposure exists. In
implantation can also be used for pars plana such eyes a conventional tube can be used. One
implantation. In some eyes with scarred con- should make sure that while inserting the tube
junctiva, there may not be enough place for the into the pars plana, the tube does not acutely
7  Pars Plana Ahmed Glaucoma Valve: Surgical Technique 43

Fig. 7.6  B scan of


choroidal effusion
occuring post
operatively 1 day after
AGV implantation

turn and get kinked. Adequate length of the into the pars plana, without disturbing the poste-
tube should be left intraocularly, so that acci- rior part of the tube or plate.
dental retraction does not take place. The tube The Tenon’s capsule is thicker posteriorly, and
should also be externally anchored to the sclera if exposure of the tube is anterior, close to the lim-
with a figure-of-eight suture. The plate should bus, repositioning the tube into the pars plana can
also be firmly anchored on the sclera to prevent be an option. This is preferable in eyes where the
anterior or posterior migration (Fig. 7.6). conjunctiva is scarred due to previous surgeries.
3. In some eyes (aphakic or pseudophakic), the Progressive endothelial call loss is a complica-
insertion of the tube could be into the ciliary tion of AGV implantation into the AC.  Various
sulcus. The valve used here, could be either factors could contribute to this including intermit-
FP 7 or FP 8, which is meant for anterior tent contact between the tube and endothelium
chamber insertion. This type of insertion is with lid closure while blinking/eye rubbing in
preferred especially in eyes post keratoplasty, children and anteriorly directed tube which could
as the tube is well away from the corneal be touching the endothelium. In a vitrectomized
endothelium. eye, shifting the entry of the tube into the pars
plana can prevent further loss of endothelial cells.

7.7 Special Situations


7.8 Postoperative Management
Posterior/pars plana relocation of anteriorly
placed valve: In situations where there is anterior Postoperatively, topical steroid antibiotic drops
tube exposure near the limbus, an existing AGV are used on a 2 hourly frequency and tapered over
tube can be removed from the AC and reinserted a period of 6 weeks. Antiglaucoma medications
44 G. J. Murthy et al.

are stopped. Topical mydriatic cycloplegic like lead to the tube retracting and could result
atropine 1% is used to stabilize the blood ocular in failure of aqueous drainage. This can
barrier and also prevent the occurrence of aque- be diagnosed by ultrasound biomicros-
ous misdirection. copy of the tube area. Retraction is less
likely to occur with the presence of the
pars plana clip.
7.9 Complications (b) Tube/pars plana clip exposure: In previ-
ously operated eyes, the conjunctival
1. Immediate postoperative healing may be compromised and may
(a) Choroidal effusion and delayed supracho- result in tube exposure. Also, in some
roidal hemorrhage eyes where the scleral/pericardial patch
• When high IOP is suddenly reduced graft melts postoperatively, progressive
especially in single-chamber, vitrecto- rubbing of the conjunctiva by lid move-
mized aphakic eyes, choroidal effusion ment may result in tube exposure.
results. In an elderly patient, or in the Tube exposure, if left untreated, can
presence of predisposing factors, huge lead to endophthalmitis with devastating
choroidal effusion can lead to stretch- consequences.
ing of the vortex veins and sudden (c) Conjunctival fibrosis around tube plate
bleeding into the suprachoroidal space, which results in decreased filtration and
leading to delayed suprachoroidal elevation of IOP.
hemorrhage.
Choroidal effusions which are small
can be conservatively managed with topi- 7.10 Literature Review
cal and if necessary systemic steroids, and
if non-­resolving, may require drainage. Various studies have established the efficacy of
Delayed suprachoroidal hemorrhage pars plana implantation of AGV in eyes with
is a devastating complication, and after glaucoma, which have undergone pars plana vit-
initial conservative management allow- rectomy. All studies demonstrate good IOP con-
ing time for the blood clot to lyse, trol but have a percentage of patients requiring
drainage of the choroidal hemorrhage subsequent explantation of the valve due to expo-
is undertaken. sure and other complications.
In eyes with preexisting retinal In a long-term study, by Mazinani et al., with
pathologies, occurrence of these com- a mean follow-up of 23.6 months, 27 eyes showed
plications may also affect the final out- good control of IOP from a pre-op mean of
come of vision and IOP control. 30.2 mmHg to 13 mmHg postoperatively after a
(b) Blockage of tube with remaining cuff of follow-up of 36 months. However, five eyes
vitreous required explantation of the valve for various rea-
• If the tube length is small, in some sons [1]. Similar results have been reported in
instances, the peripheral cuff of vitre- other studies too [2–5].
ous which remains could block the Comparison of pars plana vs anterior chamber
opening of the tube, thereby preventing implantation has also shown similar IOP control in
aqueous drainage. Ensuring adequate refractory glaucoma eyes. Maris et  al. compared
length of the tube intraocularly the clinical outcomes of posterior segment vs.
(5–6 mm), and ensuring that complete anterior chamber implantation of AGV and found
vitrectomy has been done, will prevent similar post-op IOP reduction, success rates, post-
this complication. operative medications, and similar Kaplan-Meier
2. Intermediate and late complications survival curve analysis. There were more instances
(a) Retraction of the tube: Posterior migra- of early postoperative flat AC in the anterior group
tion of the plate, postoperatively, could than the posterior group (P = 0.01) [6].
7  Pars Plana Ahmed Glaucoma Valve: Surgical Technique 45

The pars plana clip in the device has also been 2. Dada T, Bhartiya S, Vanathi M, Panda A.  Pars
plana Ahmed glaucoma valve implantation with
shown to be effective; however there are studies triamcinolone-­assisted vitrectomy in refractory glau-
which demonstrate that implantation of the AGV comas. Indian J Ophthalmol. 2010;58(5):440–2.
device without the clip into the pars plana can 3. Adachi H, Takahashi H, Shoji T, Okazaki K,
also be effective [7, 8]. Hayashi K, Chihara E.  Clinical study of the pars
plana Ahmed glaucoma valve implant in refractory
Pars plana valve implantation has been shown glaucoma patients. Nippon Ganka Gakkai Zasshi.
to be particularly more effective in particular in 2008;112(6):511–8.
eyes with post-penetrating keratoplasty, neovas- 4. Suárez-Fernández MJ, Gutiérrez-Díaz E, Julve San
cular glaucoma, and refractory glaucomas asso- Martín A, Fernández-Reyes MF, Mencía-Gutiérrez
E. Simultaneous pars plana vitrectomy and glaucoma
ciated with diabetic retinopathy requiring drainage device implant. Arch Soc Esp Oftalmol.
vitrectomy and glaucoma surgery. 2010;85(3):97–102.
Various studies have shown that pars plana 5. Lee JY, Sung KR, Tchah HW, Yoon YH, Kim JG,
implantation of AGV may be preferred in post-­ Kim MJ, Kim JY, Yun SC, Lee JY. Clinical outcomes
after combined Ahmed glaucoma valve implantation
penetrating keratoplasty eyes, as it may have and penetrating keratoplasty or pars plana vitrectomy.
lower level of endothelial cell damage while Korean J Ophthalmol. 2012;26(6):432–7.
maintaining similar level of IOP control [9, 10]. 6. Maris PJ Jr, Tsai JC, Khatib N, Bansal R, Al-Aswad
Graft decompensation, however, remains a pos- LA.  Clinical outcomes of Ahmed Glaucoma valve
in posterior segment versus anterior chamber. J
sibility in the postoperative period, and this may Glaucoma. 2013;22(3):183–9.
reflect the associated ocular morbidity and clini- 7. Diaz-Llopis M, Salom D, García-Delpech S, Udaondo
cal complexity in these eyes [11]. P, Millan JM, Arevalo JF. Efficacy and safety of the
Pars plana AGV either as a combined proce- pars plana clip in the Ahmed valve device inserted via
the pars plana in patients with refractory glaucoma.
dure with pars plana vitrectomy or as a procedure Clin Ophthalmol. 2010;4:411–6.
post vitrectomy has been shown to be effective in 8. Wallsh JO, Gallemore RP, Taban M, Hu C, Sharareh
the management of neovascular glaucoma [12]. It B. Pars plana Ahmed valve and vitrectomy in patients
has also been shown to be effective as a com- with glaucoma associated with posterior segment dis-
ease. Retina. 2013;33(10):2059–68.
bined procedure along with pars plana vitrectomy 9. Seo JW, Lee JY, Nam DH, Lee DY.  Comparison of
in eyes with vitreoretinal comorbidities and glau- the changes in corneal endothelial cells after pars
coma [13]. plana and anterior chamber Ahmed valve implant. J
In eyes after silicone oil endotamponade, Ophthalmol. 2015;2015:486832.
10. Parihar JK, Jain VK, Kaushik J, Mishra A. Pars Plana-­
AGV can control the IOP in the majority of eyes. modified versus conventional Ahmed glaucoma valve
However, the presence of silicone oil is associ- in patients undergoing penetrating keratoplasty: a
ated with increased risk of surgical failure in eyes prospective comparative randomized study. Curr Eye
treated with the AGV [14]. Silicone oil has also Res. 2016:1–7.
11. Lieberman RA, Maris PJ Jr, Monroe HM, Al-Aswad
been shown to migrate into the subconjunctival LA, Bansal R, Lopez R, Florakis GJ.  Corneal graft
space and orbit, in such eyes [15]. survival and intraocular pressure control in coexist-
Blocked tubes in the pars plana have been ing penetrating keratoplasty and pars plana Ahmed
managed by flushing the tube ab interno or by Glaucoma Valves. Cornea. 2012;31(4):350–8.
12. Faghihi H, Hajizadeh F, Mohammadi SF, Kadkhoda
injecting tissue plasminogen activator intravit- A, Peyman GA, Riazi-Esfahani M. Pars plana Ahmed
really [16, 17]. valve implant and vitrectomy in the management
of neovascular glaucoma. Ophthalmic Surg Lasers
Imaging. 2007;38(4):292–300.
13. Wallsh JO, Gallemore RP, Taban M, Hu C, Sharareh
References B. Pars plana Ahmed valve and vitrectomy in patients
with glaucoma associated with posterior segment dis-
1. Mazinani B, Schwarzer H, Willkomm A, Weinberger ease. Retina. 2013;33(10):2059–68.
A, Plange N, Walter P, Rössler G.  Ahmed glau- 14. Ishida K, Ahmed II, Netland PA.  Ahmed glau-

coma valve via pars plana access. Long-term results coma valve surgical outcomes in eyes with and
of implantation for therapy refractive glaucoma. without silicone oil endotamponade. J Glaucoma.
Ophthalmologe. 2013;110(6):537–42. 2009;18(4):325–30.
46 G. J. Murthy et al.

15.
Nazemi PP, Chong LP, Varma R, Burnstine vator as treatment for an occluded pars plana glau-
MA. Migration of intraocular silicone oil into the sub- coma tube. Clin Ophthalmol. 2009;3:91–3.. Epub
conjunctival space and orbit through an Ahmed glau- 2009 Jun 2
coma valve. Am J Ophthalmol. 2001;132(6):929–31. 17. Odrich S, Wald K, Sperber L. Ab interno management
16. Tsui I, Airiani S, Wen A, El-Sawy T, Fine HF, Maris of blocked Ahmed valve in the posterior segment.
PJ Jr. Intravitreal injection of tissue plasminogen acti- Glaucoma. 2013;22(5):e9–10.
Surgical Technique for Baerveldt
Glaucoma Devices 8
Gurjeet Jutley and Laura Crawley

Aims of this chapter: optometrist-led care from “Google DeepMind”


optical coherence tomography and better medical
• When to consider a drainage device therapy from an explosion of topical neuromodu-
• Types available latory agents can only be the future of glaucoma
• Latest evidence [1], affording our patients the best possible
• Surgical steps opportunity to preserve retinal ganglion cells.
• Common pitfalls Irrespective of this, we know a subset of patients
• Complications will have accelerated disease, and as such surgi-
• Summary cal intervention is crucial. It is the 50th anniver-
• Also refer to the surgical steps videos, with sary of the humble trabeculectomy, and along the
accompanying commentary way important technique modification has
ensured it is an excellent surgical option, includ-
Glaucoma management has entered an excit- ing the advent of the safe surgical technique with
ing era; with many ophthalmologists enthused releasable sutures and the use of antimitotic
from the plethora of interventions, we can offer agents.
to both delay and circumvent irreversible sight So if this is the case, what need is there for
loss that otherwise would be inevitable from this glaucoma drainage devices (GDD)? Well in those
devastating condition. In the United Kingdom, situations where progressive disease is noted
the healthcare system is entering an era of auster- despite optimised medical therapy and a trabecu-
ity, and as such primary prevention with commu- lectomy has either failed or is likely to fail, a
nity follow-up is critical. Newer interventions GDD would be an excellent option. The follow-
such as earlier diagnosis through the “detecting ing prompt consideration of the use of GDDs:
apoptotic retinal cells” systems, greater patient
ownership of their condition via home tonometry, • Neovascular glaucoma
• Iridocorneal endothelial (ICE) syndrome
Electronic Supplementary Material  The online version • Traumatic glaucoma
of this chapter (https://doi.org/10.1007/978-981-13-5773- • Uveitic glaucoma
2_8) contains supplementary material, which is available • Failed trabeculectomy
to authorized users.
• Epithelial downgrowth
G. Jutley (*) • Refractory infantile glaucoma
Oxford University Hospital, Oxford, UK • Aphakic glaucoma
L. Crawley • Glaucoma in the presence of a penetrating ker-
Imperial College London, London, UK atectomy or previous pars plana vitrectomy
© Springer Nature Singapore Pte Ltd. 2019 47
M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_8
48 G. Jutley and L. Crawley

8.1  Types of GDD with a small pressure differential between


the AC and the bleb.
The basic design of all GDD is the same with a
The GDDs without resistance valves are:
silicone tube connecting the anterior chamber (or
vitreous cavity in the case of pars plana tubes) to • Molteno
the plate, anchored in the subconjunctival space. –– Newer designs implemented in clinical
The design is desirable since the actual tube pre- practice since 1973.
vents adherence of fibroblasts, whilst the equato- –– Long silicone tube approximately 10 mm.
rial explant stimulates a foreign body reaction, • Baerveldt (BVT)
thus giving rise to capsule formation, constituting
the hypertensive phase at 6  weeks. The actual The BVT is a non-valved silicone tube device,
capsule has a passive function, enabling the with a large pliable silicone plate, available in
egress of aqueous fluid through to the subcon- 250, 350 or 500 mm2 [2] (Fig. 8.1).
junctival space. It will certainly limit the filtration
rate, and at the height of the hypertensive phase,
the intra-ocular tension often increases, necessi- 8.2  Why Use BVT Over the Others
tating the removal of the Supramid suture occlud- Available?
ing the lumen of the GDD.
The various tubes are subdivided by: The Ahmed versus Baerveldt study was an inter-
national, multicentre RCT of 238 patients with
• The presence or absence of a flow valve. high-risk glaucoma [3, 4]. The patients may or
• Size and shape of the external components. may not have had previous interventions, with
mean IOP of 31.4 ± 10.8 mmHg. The 3-year data
Valved GDD’s with set resistance: revealed:

• The cumulative probability of failure was


• Krupin
higher in the Ahmed group.
• Ahmed
–– 51% versus 34%, p = 0.03.
–– The silicone tube is connected to a silicone
• Trend towards lower IOP in the BVT group.
sheet valve which is placed in the 180 mm2
–– 14.4 ± 5.1 mmHg versus 15.7 ± 4.8 mmHg,
polypropylene body.
p = 0.09.
–– Two thin silicone elastomer membranes
create a venturi chamber.
–– A pressure differential across the valve The results of this study were very similar to the
gives it opening pressure of 7–8 mmHg. eminent ABC study [3–8]. An interesting theory is
–– The inlet cross-section of the chamber is that since the BVT is occluded with the Supramid
wider than the outlet (Bernoulli principle), suture [9] until a bleb forms around the plate
with the resultant pressure differential (approximately after 6 weeks), it is not exposed to
enabling the valve to remain open even aqueous in the early post-operative period. It is

Fig. 8.1  Various BVT


available, with the
variability seen in the
size of the plate
8  Surgical Technique for Baerveldt Glaucoma Devices 49

postulated that that aqueous in this period will should be interpreted accounting for
result in bleb remodelling, due to pro-­inflammatory this.
mediators. Conversely, this aqueous exposure in One of the failure criteria was IOP less than
the Ahmed valve will lead to the requirement of 5  mmHg. However, the visual acuity
glaucoma medications in the long term [10]. was not stated for these patients: it is
absolutely plausible for the pressure to
be in the “hypotony” range, but as long
8.3  Latest Evidence: Tube or Not as the acuity is preserved, these should
to Tube? not be deemed as unsuccessful.
The MMC was used for 4  min, which is
• Should you do trabeculectomy or proceed may be longer than used by most clini-
directly to GDD? cians. This could explain the higher
• Trab Versus Tube (TVT study) [11, 12]: rates of hypotony.
–– Multisite, RCT from the USA. Only BVT 350 is used, and hence the
–– Cohort included patients 18–85  years of results cannot be extrapolated to other
age who have undergone: tubes.
Previous trabeculectomy. Non-standardized surgical techniques.
Cataract extraction. • Primary TVT study [13, 14]:
–– 212 eyes of 212 patients: –– This study is more powerful as all eyes
107 in the BVT 350. enrolled into the study had no previous sur-
105  in the trabeculectomy group (with gical interventions.
mitomycin mg/ml used for 4 min). –– The results are eagerly awaited to be
–– Mean IOP at 1 year was similar: published.
12.4 ± 3.9 mmHg (mean +/-SD) in the tube –– The preliminary first-year data presented at
group. the American Academy of Ophthalmology
12.7 ± 5.8  mmHg in the trabeculectomy in October 2016 was hugely encouraging
group (p = 0.73). with:
–– However, the following favoured the use of –– Failure rates:
tube: Trab = 8%.
The cumulative probabilities of failure dur- Tube = 20%.
ing the first year of follow-up were 3.9% –– Complete success:
in the tube group and 13.5% in the trab- Trab = 59%.
eculectomy group (p = 0.017). Tube = 14%.
Postoperative complications developed in
36 patients (34%) in the tube group and
60 patients (57%) in the trabeculectomy 8.4  Technique
group during the first year of follow-up
(p = 0.001). Our experience has taught us that the pre-­
–– At 5 years, the Kaplan-Meier survival anal- operative consent, rapport and relationship with
yses revealed the cumulative probability of the patient are critical to ensure that a properly
failure as: treated patient is also a happy patient. Important
Tube = 29.8%. aspects to cover:
Trab = 46.9%.
–– These results should be interpreted with • Frequent follow-up and drop administration in
utmost caution, due to the justifiable criti- the immediate post-operative period.
cism of the study: • The likelihood of going back to theatre to
The patients already had previous interven- remove the Supramid suture.
tions. It is essentially assessing redo tra- • The likelihood of supplementary topical anti-­
beculectomy versus tube and as such hypotensive agents.
50 G. Jutley and L. Crawley

• Complications including: The BVT will often necessitate a general


–– Erosion anaesthetic, predominantly as we sling the lateral
–– Corneal decompensation and superior recti muscle, which stimulates the
–– Diplopia oculocardiac reflex. Those patients unable to tol-
–– Sensation of an object in the supero-­ erate a general anaesthetic could have an Ahmed
temporal quadrant valved tube or BVT-250.
–– Hypotony Consider the following flow diagram, contain-
–– Choroidal detachments ing surgical stills and tips:
–– Change in refraction
–– Acceleration in cataract formation, if the
patient is phakic

Corneal traction suture: ensure depth


is adequate to prevent cheese-wiring

One to two-quadrant, forniceal


peritomy. Do a relieving incision
laterally, enabling ease of slinging LR

Muscles slung: assistance help to


spread muscles can be invaluable.
8  Surgical Technique for Baerveldt Glaucoma Devices 51

Plate fixation should be10 mm behind the


limbus to ensure reduced contact with the
upper lid and risk of exposure

The implant should be secured to the outer


sclera: it needs to be anchored for 2 weeks
whilst the capsule forms. Securing the plate is
crucial to prevent tube instability in the AC with
saccades

A tunnel tract is made with a 25 gauge


needle, with a tube fed into the AC
through this using tube holding forceps.
52 G. Jutley and L. Crawley

Tube fixation achieved using box suture.


Increasingly we are using two (one adjacent to
plate and other to AC entry).

Patch graft to cover the anterior 5 mm of the


tube to prevent exposure & erosion. Our
preference is tutoplast (pericardium). Donor
sclera or cornea are other options.

Conjunctival closure is augmented with


tissue glue where available.
8  Surgical Technique for Baerveldt Glaucoma Devices 53

Anterior
aperture

Anterior chamber
Tube

Posterior
aperture

Securing
suture
holes

Tube
plate

Superior
rectus

8.5  Common Pitfalls and Solutions • Muscles


in Our Experience –– We advocate slinging both the LR and SR,
thus reducing the risk of post-operative
• Patient selection restrictive myopathy.
–– Ensure patients are motivated and physi- • Fixing the plate
cally able to administer drops and attend –– Blunt dissection is the key here. If you find
frequent follow-up in the acute post-­ the plate is migrating forwards if you
operative period. release it when you have placed it in the
• Prepare the tube prior to surgery starting sub-Tenon’s space, clearly you have not
–– An excellent tip is to: dissected back enough. Bring out the plate
Feed the Supramid into the lumen of the and complete your dissection.
tube prior to starting the surgery. • Cutting the tube to size
Preplace the 10.0 nylon to the superior hole –– The beginning of the surgery commences
of the plate, enabling the next bite to be with a traction suture to pull the eye infero-­
into the sclera, ready to be tied. nasally. When adjusting the tube length,
• Conjunctiva bring the eye back to primary position, and
–– Ensure the history of previous surgery is cut the tube flush to ensure an entry into the
elicited. Previous vitreoretinal surgery or AC. This can be trimmed later if originally
conjunctival disturbing procedures affects it is too long.
the initial dissection. The conjunctiva will –– In fact, cutting it longer is desirable as the
be friable and prone to button-holes: know- adjustments can be made sequentially,
ing in advance can allow both sufficient ensuring the length is not too short in the
time and adjuncts (such as amnion grafts) first instance.
to be available.
54 G. Jutley and L. Crawley

• Paracentesis and sclerostomy 8.6  Complications


–– Using viscoelastic in the AC helps to stabi-
lise the AC prior to sclerostomy. • Hypotony
–– Injecting viscoelastic through the entry –– The aetiology of which is important to
tunnel can ease tube insertion and help the elicit:
tube glide seamlessly into the AC. Over-filtration
–– Occasionally the tube doesn’t fit into the Ciliary body shut down can be treated by
AC: please check the tract is not directed increasing the frequency of steroid
superiorly so the tube is abutting the drops alongside atropine drops.
Descemet’s membrane. There may be drainage adjacent to the tube
–– Use the open-toothed forceps to go through entry point if the sclerostomy was too
the tract, and manipulate with the smooth large (hence importance of using
shaft to loosen the tract. 22-gauge needle). Injecting Healon into
• Box sutures to fix tube the eye and assessing whether it is
–– Do two: one at the entry of tube at scleros- retained in the AC will be the ultimate
tomy site and other further distal towards diagnostic test for this. Ultimately a
the plate. revision may be necessary.
–– Ensures the tube will not dislodge. • Choroidal effusions
–– Some surgeons will advocate Vicryl tie • Suprachoroidal haemorrhage
around the tube to pinch the edges and –– The presentation is typically with sudden
reduce the initial flow whilst the capsule is excruciating pain with increased IOP in the
maturing. operated eye either during the operation or
• Tuck the loose end of the Supramid into the in the postoperative period.
inferior conjunctival pocket –– Clinical signs include a shallow AC,
–– This can be placed under or over the LR. increased IOP, and choroidal elevations that
–– A tip is to crush the end, compressing it appear darker than choroidal effusions.
with a Castroviejo needle holder. This –– B-mode ultrasonography is helpful in mak-
ensures the end doesn’t have a propensity ing this diagnosis.
to poke up outside the conjunctiva, poten- –– Management includes:
tially irritating the patient or eroding Supportive therapy
through. Topical and oral steroids
• Tutoplast cover and conjunctival closure Topical and oral ocular hypotensives
–– Adequate suturing with 10/0 nylon or tis- Cycloplegic agents
sue glue can be used to ensure closure. Analgesia
With tissue glue, separating it into thick –– Indications for drainage include:
and thin components ensures greater con- Excruciating pain
trol. The conjunctival closure is augmented Involvement of the macula by the
with 10.0 nylon closure, with a variety of haemorrhage
continuous and mattress techniques Kissing choroidals
adopted. Corneal-lenticular touch
8  Surgical Technique for Baerveldt Glaucoma Devices 55

• Blockage of tube • Tube migration, including:


–– This may necessitate YAG laser (using an –– Extension
Abraham’s iridotomy lens) to the end of –– Retraction
the tube, typically three/four shots at There is a risk that if the tube is cut too
1  mJ.  Lasering the tube opening causes a short, it can retract out of the anterior
shock wave to propagate up the tube and chamber due to post-operative subcon-
dislodge any debris. Alternatively, it may junctival fibrosis.
need to be formally flushed in theatre with • Strabismus and ptosis
balanced salt solution. • Infection [17]
• Aqueous misdirection
–– Can occur months post-operatively
• Corneal decompensation [15] 8.7  Summary
–– The incidence is 10–20% irrespective of
the GDD used. A plethora of options for the glaucoma surgeon
–– The possible aetiologies include: ensures an impressive armamentarium. In the
Physical endothelial touch, necessitating new dawn of minimally invasive surgery, it is
repositioning. important to reflect on the staple interventions
Cytokine-mediated damage, from low-­ and arguably procedures we have 50-years
grade inflammation. experience with are still the most effective. We
• Tube erosion have seen the evidence, indication, technique
–– Particularly in multi-systemic inflamma- and common pitfalls of Baerveldt tube surgery.
tory conditions. The accompanying video will augment this
–– For example, we recently managed a chapter and ensure you are adequately prepared
patient with systemic sclerosis with recur- for this surgery. Remember, adequately consent
rent conjunctival erosion following a your patient and ensure careful follow-up to
Baerveldt 350 [16]. We managed this manage to ensure both a happy surgeon and
patient by harvesting the capsule over the more importantly a happy patient.
original tube, a double-layered Tutoplast
on the scleral bed, and placing a pars plana Acknowledgements  Professor Philip Bloom at Western
tube (PPT), the plate of which is distal Eye Hospital for access to his clinical photos.
from the site of the previous necrosis. We
postulated the site of the original necrosis
was due to tight eyelids and made use of
the fact that the plate of the PPT was away
from this area.
56 G. Jutley and L. Crawley

References tive intraocular pressure control. Ophthalmology.


1998;105:2243–50.
10. Prata JA Jr, Mermoud A, LaBree L, et al. In vitro and
1. Jutley G, Luk S, Dehabadi M, Cordeiro
in  vivo flow characteristics of glaucoma drainage
MF. Management of glaucoma as a neurodegenerative
implants. Ophthalmology. 1995;102(6):894–904.
disease. Neurodegen Dis Manag. 2017;7(2):157–72.
11. Gedde SJ, Schiffman JC, Feuer WJ, et al. Three-year
2. Lloyd MA, Baerveldt G, Fellenbaum PS, et  al.
follow-up of the Tube Versus Trabeculectomy Study.
Intermediate-term results of a randomized clini-
Am J Ophthalmol. 2009;148:670–84.
cal trial of the 350 versus the 500 mm2 Baerveldt
12. Gedde SJ, Schiffman JC, Feuer WJ, et al. Treatment
implant. Ophthalmology. 1994;101:1456–64.
outcomes in the Tube Versus Trabeculectomy (TVT)
3. Christakis PG, Kalenak JW, Zurakowski D, et  al.
Study after five years of follow-up. Am J Ophthalmol.
The Ahmed Versus Baerveldt Study. Design, base-
2012;153:789–803.
line characteristics, and intraoperative complications.
13. Gedde S.  Treatment outcomes in the Primary Tube
Ophthalmology. 2011;118:2172–9.
Versus Trabeculectomy (PTVT) study after 1 year
4. Christakis PG, Tsai JC, Zurakowski D, et  al. The
of follow-up. Presented at: American Academy of
Ahmed Versus Baerveldt Study. One-year treatment
Ophthalmology Annual Meeting; Oct. 14–18, 2016;
outcomes. Ophthalmology. 2011;118:2180–9.
Chicago.
5. Barton K, Gedde SJ, Budenz DL, et  al. The Ahmed
14. Lim S.  Postoperative complications in the Primary
Baerveldt Comparison Study: methodology, baseline
Tube Versus Trabeculectomy (PTVT) study during
patient characteristics, and intraoperative complica-
the first year of follow-up. Presented at: American
tions. Ophthalmology. 2011;118:435–42.
Academy of Ophthalmology Annual Meeting; Oct.
6. Barton K, Feuer WJ, Budenz DL, et  al. Three-year
14–18, 2016; Chicago.
outcomes in the Ahmed Baerveldt Comparison (ABC)
15. Sherwood MB, Smith MF, Driebe WT Jr, et  al.

Study. Ophthalmology. 2014;121(8):1547–57.
Drainage tube implants in the treatment of glaucoma
7. Budenz DL, Barton K, Feuer WJ, et  al. Treatment
following penetrating keratoplasty. Ophthalmic Surg.
outcomes in the Ahmed Baerveldt Comparison
1993;24(3):185–9.
Study after one year of follow-up. Ophthalmology.
16. Jutley G, Yang E, Bloom PA.  Surgical management
2011;118:443–52.
of raised intra-ocular tension in the hostile ocular sur-
8. Christakis PG, Tsai JC, Kalenak JW, et al. The Ahmed
face: recurrent tube erosion in a patient with systemic
Versus Baerveldt Study. Three-year treatment out-
sclerosis. BMC Ophthalmol. 2018;18(Suppl 1):222.
comes. Ophthalmology. 2013;120:2232–40.
17. Tarbak AAA, Shahwan SA, Jadaan IA, et  al.

9. Trible JR, Brown DB.  Occlusive ligature and stan-
Endophthalmitis associated with the Ahmed glaucoma
dardized fenestrations of a Baerveldt tube with
valve implant. Br J Ophthalmol. 2005;89:454–8.
and without antimetabolites for early postopera-
Molteno Implants: Surgical
Technique 9
Parth R. Shah, Ashish Agar, and Colin I. Clement

9.1 Introduction and Literature tant to know exactly which model is used as the
Review surgical technique is slightly different for each.
All Molteno implants are safe with MRI.
Molteno implants (Molteno Ophthalmic Limited, Several studies have shown the efficacy of the
Dunedin, New Zealand) were developed by Molteno implants. Molteno and colleagues com-
Anthony CB Molteno in the 1960s and were the pared the outcomes from the largest database of
first glaucoma drainage implants in the world. Molteno implants in the Otago Glaucoma Surgery
They comprise a fine-bore silicone tube attached Outcome Study. This included 718 cases of trab-
to an injection-moulded polypropylene plate eculectomy and 260 cases of Molteno implants
drainage plate. There are now several models of over 17 years. Results from single-plate, double-­
the Molteno implant available, each successive plate and Molteno3 glaucoma implants were
model incorporating changes based on surgical combined and reported as one group. They con-
experience and outcomes (Table 9.1). It is impor- cluded that insertion of a Molteno implant pro-
vided superior long-term IOP control to
trabeculectomy when carried out as a first opera-
tion in cases of primary glaucoma [1]. At 5-year
follow-up, of those with Molteno implants, 21%
P. R. Shah
Prince of Wales Hospital, Randwick, NSW, Australia were on no hypotensive medications, 64% were
on one medication, and 15% required two or
A. Agar
Glaucoma Unit, Prince of Wales Hospital, more hypotensive medications [1].
Sydney, NSW, Australia A retrospective single-centre case series from
Glaucoma Unit, Sydney Eye Hospital, Finland found that Molteno3 implants for uncon-
Sydney, NSW, Australia trolled glaucoma reported a 28% complete suc-
Marsden Eye Specialists, Sydney, NSW, Australia cess rate (IOP 6–20 mmHg off glaucoma drops)
and 50% qualified success rate (IOP 6–20 mmHg
Department of Ophthalmology, University of New
South Wales, Sydney, NSW, Australia on 1 or more glaucoma drops) [2]. The group
included patients who had failed previous glau-
C. I. Clement (*)
Glaucoma Unit, Sydney Eye Hospital, coma procedures. A case series of Molteno
Sydney, NSW, Australia single-­plate implants showed effective long-term
Eye Associates, Sydney, NSW, Australia IOP lowering when performed as the primary
surgical procedure for the management of uveitic
Fairfield Eye Surgery, Sydney, NSW, Australia
glaucoma [3]. The author commented that IOP
Discipline of Ophthalmology, The University of fell progressively during the first year after the
Sydney, Sydney, NSW, Australia

© Springer Nature Singapore Pte Ltd. 2019 57


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_9
58 P. R. Shah et al.

Table 9.1  Currently available Molteno implant models (modified and used with permission from Professor AT
Molteno)
9  Molteno Implants: Surgical Technique 59

surgery, and the medication was slowly tapered 9.2 Device Selection
even up to 3 years postoperatively.
The Otago Glaucoma Surgery Outcome The plate area necessary for IOP control depends
Study showed that 3-year results for the on patient age, glaucoma severity and previous
Molteno3 implant were comparable with the ocular history. In general, the greater the amount
double-plate implant [4]. There have been few of aqueous to be drained and the stronger the
direct comparative studies between the most patient’s fibrosing response, the greater the area
popular Molteno, Ahmed and Baerveldt required for drainage [7].
implants. A Cochrane review of aqueous shunts The most recent model, Molteno3, has the fol-
for glaucoma in 2009 reported that there is no lowing features (Fig. 9.1):
evidence of superiority of one glaucoma tube
shunt over another [5]. One study showed that • Thin plate profile: 0.4 mm thick
Molteno single-plate implants achieved lower • Larger drainage area comparable to the Ahmed
IOP in the long term compared with the Ahmed implant
FP7 valved implant (New World Medical, Inc., • Primary and secondary drainage areas
Rancho Cucamonga, California, USA), with • Curved to match the shape of the globe: mak-
similar rates of surgical failure [6]. ing it suitable for myopic eyes and in patients
with tight orbits
• Single quadrant surgery

Fig. 9.1 Molteno3 Secondary drainage area Primary drainage area


device. From: Molteno
AC. Molteno3
Glaucoma Drainage
Device Surgical Guide.
2006. Available via:
https://www.molteno.
com/files/299/file/
Suture hole
Molteno-Surgical-
Guide-SG-GDD-0816-
pdf
Ridge

Suture hole

Translimbal tube
60 P. R. Shah et al.

• Same performance as the earlier model 1. Local (sub-Tenon or peribulbar block) or


double-­plate implant [4] general anaesthesia.
• Trans-limbal or pars plana insertion 2. Betadine prep and sterile head drape.
• Can be positioned supra-Tenon’s if necessary 3. 7-0 silk superior corneal stay suture (see
• Flexible curved plate, slides into place easily Fig. 9.3 for location).
• Anterior suture hole position for fast, easy 4. Limbal conjunctival peritomy to create
insertion 4-clock hour fornix-based conjunctival flap.
(a) Quadrant selection: in general, the supe-
rior temporal quadrant is preferred as
9.3 Surgical Technique surgical exposure is better.
for Insertion of Molteno •  The inferior quadrants may be used
Glaucoma Implant when superior quadrant access is lim-
ited. The inferior temporal quadrant is
9.3.1 List of Surgical Instruments preferred in order to minimise the risk of
diplopia in patients with good vision in
• Molteno implant both eyes.
• Lid speculum •  In eyes containing silicone oil, the
• Fine-spring scissors implant can be placed superiorly or infe-
• Non-toothed forceps for handling conjunctiva riorly. Any silicone oil entering the tube
2× drains to the bleb, and silicone oil that
• Squint hooks 2× rarely blocks the ostium can be cleared
• Steri-Strips with neodymium:YAG laser [7].
• Cautery (b) A non-toothed forcep and fine-spring

• Fine non-toothed suture tying forceps scissors are used to make a perilimbal
• Fine needle holder incision through conjunctiva and Tenon’s
• 2 ml syringe 3× capsule with radial relieving incisions at
• 23-gauge needle each end in order to expose sclera and
• Rycroft cannula the rectus muscle insertions in the appro-
• 7-0 silk suture 2× (or 8-0 Prolene) priate quadrant(s).
• 5-0 Vicryl (polyglactin 910) suture 1× 5. Meticulous bipolar diathermy of episcleral
(optional) vessels.
• 10-0 nylon suture 2× (or 8-0 Vicryl) 6. Exposure of rectus muscles.
• 3-0 nylon or Supramid (polyamide) suture (a) Suture tying of the recti muscles is
• Anterior chamber maintainer (optional) widely described however is not neces-
• 15° super sharp blade sary in the authors’ opinion.
• In cases where the patient’s own sclera cannot (b) Using blunt dissection, Tenon capsule is
cover the tube, donor sclera, or equivalent tis- dissected posteriorly to expose bare
sue such as Tutoplast (Innovative Ophthalmic sclera 3  mm posterior to the muscle
Products, Inc., Costa Mesa, CA, USA) insertions.
• Balanced salt solution 10 mL 7. Position and secure Molteno implant.
• Subconjunctival antibiotics and steroid (a) The plate is sutured between and slightly
beneath recti muscles. The plate is posi-
tioned so that it lies symmetrically
9.3.2 Step-by-Step Guide between the rectus muscles, in order to
to Insertion of Molteno minimise the risk of post-operative
Implant diplopia.
(b) A 7-0 silk suture (or 8-0 or 9-0 Prolene)
Figure 9.2 summarises the steps involved for the is passed through sclera at the rectus
insertion of a Molteno glaucoma implant. muscle insertion, from below up through
9  Molteno Implants: Surgical Technique 61

4-clock hour conjunctival


peritomy

Diathermy

Expose recti muscles

Healthy, thick Unhealthy, thin


Lamellar scleral flap Scleral Donor sclera
hinged at limbus health graft

Position and secure


implant

Trim tube to correct


length

Absorbable suture ligation *

Paracentesis

Channel formation: sulcus,


AC, pars plana

Insert tube

Relieving incisions *

* Optional steps Conjunctival closure

Fig. 9.2  Flowchart summarising the surgical steps in the insertion of a Molteno implant
62 P. R. Shah et al.

long shelf life and therefore easily acces-


sible in cases where urgent surgery is
required.
9. Trim tube to desired length.
(a) Position the tube across the desired loca-
tion, conventionally oriented perpendic-
ularly to the limbus in line with the
origin of the tube from the plate. Trim
the end of the tube 2 mm beyond the lim-
bus at an angle of 45° with the bevel fac-
ing forward. Take care not to stretch the
tube and preferably leave a margin of
Fig. 9.3  Channel formation into ciliary sulcus using
2  mm in addition to the desired length
23Ga needle, 3 mm from limbus
just in case there is inadvertent stretch.
Remember a long tube can always be
the anterior suture hole in the plate, then trimmed further, but if cut too short, the
return the suture through sclera at the tube cannot be lengthened!
muscle insertion in a posterior to ante- 10. Intraluminal stent.
rior direction (mattress suture). Pull the (a) A 3-0 nylon or 3-0 Supramid (polyam-
suture tight and tie a knot. Repeat this ide) suture is used as an intraluminal
suture on the other side of the plate [7]. stent. The suture is positioned such that
(c) A 7-0 silk suture is recommended the intraluminal portion ends prior to the
because it is braided, holds well in thin tube entering the eye. The other end is
and friable tissues and has a nice suture placed under the lateral rectus and into
needle for scleral bites. The advantage of the inferior fornix to facilitate removal at
the alternative Prolene is durability with the slit lamp or in theatres.
reduced chance of plate migration [7]. 11. Channel formation and tube insertion.
8. Scleral covering. (a) The Molteno tube can be inserted into
(a) A scleral covering over the length of the the sulcus, anterior chamber (AC) or
tube is important to prevent tube extru- pars plana.
sion through the conjunctiva. (b) An anterior chamber (AC) paracentesis
(b) This can be achieved with the creation of is made using a 15° super sharp blade.
a lamellar scleral flap as for a trabeculec- This allows for reformation of the cham-
tomy. The advantage of this is that it ber once the tube is placed. An AC main-
avoids the tenting associated with a tainer can be inserted through the
donor sclera. The disadvantage is that it paracentesis (optional step, see Fig. 9.5).
results in more anterior insertion of the (c) The authors prefer a ciliary sulcus loca-
tube, which may be more likely to erode tion in all pseudophakic eyes to avoid
through sclera. There is also a theoreti- endothelial dysfunction associated with
cal risk of posterior erosion of the tube an anterior chamber tube.
into underlying choroid. •  A 23-gauge needle on viscoelastic is
(c) If the sclera is thin or unhealthy, as is passed through the sclera 3  mm from
often the case for patients who are candi- the limbus into the ciliary sulcus in a
dates for Molteno tubes, a small piece of plane parallel to the iris and intraocular
donor sclera can be used. This can be lens (Fig. 9.3). Once the needle is esti-
cadaveric donor sclera (obtained from mated to enter the sulcus, a small vol-
local Eye Bank) or pericardium ume of viscoelastic is injected to balloon
(Tutoplast). Tutoplast has the benefit of a the iris forward and ensure there is a
9  Molteno Implants: Surgical Technique 63

clear space in which to place the tube. on the site of tube entry and observe
The needle is retracted with a small vol- how the tube within the eye moves in
ume of viscoelastic injected into the relation to the iris and intraocular lens.
scleral tunnel on the way out which (d) Anterior chamber placement.
allows subsequent tube insertion to pass •  
With the anterior chamber formed, a
more readily. 23-gauge needle is used to fashion an
•  The tube is trimmed with the aim of entry point approximately 2 mm distal
having it extend to approximately the to the limbus (Fig.  9.5). The needle is
pupil margin once positioned within the inserted downwards and forwards, aim-
eye. Unlike anterior chamber tube ing to emerge from the angle parallel to
placement, for sulcus placed tubes, the the iris plane. It is important to ensure it
bevel is cut to face backwards. The tube emerges as far as possible equidistant
is guided into the sulcus using suture from both the cornea and iris, to reduce
tying forceps (Fig. 9.4). the chance of touching either.
•  When positioned in the eye, confirm its •  A strong pair of forceps is used to thread
location within the sulcus with either the tube through this incision (Fig. 9.6).
direct visualisation or by applying alter- A small relieving cut can be made with
nating anterior and posterior pressure the needle, enlarging only the scleral
entry point slightly while preserving the
narrower intrascleral portion. This is to
reduce the risk of peri-tube aqueous
leakage which may cause hypotony
post-­operatively. If an AC maintainer is
not used, the position of the tube must
be checked with the AC reformed as the
process of insertion can result in
shallow.
•  If it still appears too close to either the
iris or cornea, then a second alternative
entry may need to be made. This will be
slightly displaced from the original site
Fig. 9.4  Insertion of trimmed tube into the ciliary sulcus and so may require additional tube

Fig. 9.5  Channel formation into the anterior chamber. Note an AC maintainer has been used in this case. Images cour-
tesy of Dr. Jed Lusthaus
64 P. R. Shah et al.

Fig. 9.6  Tube insertion into anterior chamber. Images courtesy of Dr. Jed Lusthaus

and cut the suture ends 3–4 mm long to


prevent the knot untying itself [7].
•  The Vicryl tie dissolves in 3–5 weeks. It
was proposed that aqueous begins to
drain into primary drainage area; the
pressure ridge creates a primary bleb
underneath Tenon capsule which acts as
the flap in a biological valve, keeping
aqueous in the primary area, preventing
hypotony [7]. The case series reported by
Valimaki did not find a low rate of hypot-
ony with the Molteno3 implant [2].
Fig. 9.7  Vicryl suture tie being placed around tube for •  As IOP rises, the flap lifts and aqueous
delayed drainage
drains into a secondary drainage area
where it is absorbed into the surround-
length, another reason to always trim ing tissues. A large secondary drainage
the tube slightly longer than desired. area provides for excellent absorption
(e) Pars plana placement requires a full vit- and higher IOP reduction.
rectomy to be performed. The technique •  The ‘biological valve’ is reported to be self-
is similar, but clearly the angle of inser- cleaning and resists blockage by inflamma-
tion will be much more acute. tory exudate, blood clot or fibroblast
1 2. Optional steps. ingrowth, unlike a mechanical valve [7].
(a) Delayed drainage: Vicryl suture tie. •  The Vicryl suture can be omitted when
•  A 5-0 Vicryl suture tie around the tube is treating urgent cases of acutely raised
an important step in preventing post-op intraocular pressure where medical
complications related to early over management in the immediate post-
drainage (Fig. 9.7). It allows time for the operative period is not appropriate and
­tissues to heal, resulting in a thin and significant IOP reduction is required
permeable bleb capsule. immediately. In addition, it may be omit-
•  Using a 2 mL syringe and Rycroft can- ted in some cases of neovascular glau-
nula, inject saline up the tube to test that coma, silicone oil-­ induced glaucoma
the tube has been completely occluded. and a few cases where inflammatory
Place a second throw to lock the knot exudate or blood is present in the eye.
9  Molteno Implants: Surgical Technique 65

Fig. 9.8  Relieving incisions made into tube using the Fig. 9.10  Conjunctival closure using 8-0 Vicryl suture
Vicryl suture needle

Fig. 9.9  Donor scleral graft over tube secured with 10-0
nylon Fig. 9.11  Appearance at completion of surgery with tube
placement into ciliary sulcus in pseudophakic patient

(b) Relieving incisions (Sherwood slits) can


be made in the tube anterior to the Vicryl 15. Subconjunctival injection of antibiotics

tie using the suture needle (Fig.  9.8). (cefazolin) and steroid (dexamethasone)
This assists post-operative IOP control (Fig. 9.11).
by allowing a small degree of post-­
operative drainage.
13. Scleral suturing. 9.4 Variations to Surgical
(a) The scleral flap or piece of donor sclera Technique for Different
is secured to the underlying sclera using Models
10-0 nylon or 7-0 silk (Fig. 9.9).
1 4. Conjunctival closure. 9.4.1 Paediatric Version
(a) The conjunctiva is closed using 10-0
nylon or 8-0 Vicryl using episcleral bites • In a young patient, position the Molteno glau-
at the limbus (Fig. 9.10). coma implant in an anterior position, between
(b) It is important to ensure that Tenon’s fas- the insertions of the extraocular muscles. This
cia has not been caught behind the poste- reduces the impact of subsequent growth of
rior edge of the plate and that it lies freely the globe on the length of Molteno implant
over the limbus of the eye. If caught, tubing in the anterior chamber (AC) and
carefully lift and free the tissues [7]. reduces the need for reoperation.
66 P. R. Shah et al.

9.4.2 Double-Plate Implant 2. Valimaki J.  Surgical management of glaucoma with


Molteno3 implant. J Glaucoma. 2012;21(1):7–11.
3. Vuori ML. Molteno aqueous shunt as a primary sur-
• Molteno double (twin)-plate implants provide gical intervention for uveitic glaucoma: long-term
twice the drainage area of an original Molteno results. Acta Ophthalmol. 2010;88(1):33–6.
single-plate (S1) implant without interfering 4. Thompson AM, et  al. Otago glaucoma surgery out-
come study: comparative results for the 175-mm2
with the action of the extraocular muscles. molteno3 and double-plate molteno implants. JAMA
• The Molteno double-plate implants are suit- Ophthalmol. 2013;131(2):155–9.
able for patients with very severe glaucoma, 5. Minckler DS, et  al. Aqueous shunts for glaucoma.
patients with especially vigorous fibrous tissue Cochrane Database Syst Rev. 2006;(2):CD004918.
6. Nassiri N, et  al. Ahmed glaucoma valve and single-­
response, younger patients with good ciliary plate Molteno implants in treatment of refractory
body function and patients who have glaucoma glaucoma: a comparative study. Am J Ophthalmol.
associated with uveitis or retinal detachment. 2010;149(6):893–902.
7. Thompson AM, Bevin TH, Molteno ACB.  Surgical
technique 1 (Molteno) (chapter 98). In: Shaarawy
TM, Sherwood MB, Hitchings RA, Crowston JG,
editors. Glaucoma. London: Saunders Elsevier; 2009.
References p. 403–16.

1. Molteno AC, et al. Long-term results of primary tra-


beculectomies and Molteno implants for primary
open-angle glaucoma. Arch Ophthalmol. 2011;
129(11):1444–50.
AADI Technique
10
Suresh Kumar and Sahil Thakur

10.1 Introduction 10.2 Dissection


of the Conjunctiva
Aurolab aqueous drainage implant (AADI) has
been marketed in India by Aurolab, Madurai, A peripheral clear corneal 6-0 Vicryl or 6-0
India, since June 2013. AADI is a non-valved Prolene suture to provide traction and exposure
device that is useful in refractory glaucomas of the surgical field (Fig. 10.1).
when other methods to control the intraocular The conjunctival peritomy is started in the
pressure have failed. It is made of permanent supero-temporal quadrant to raise a fornix-based
implantable grade silicone, a proven material for conjunctival flap. The preferred location for the
patient safety [1]. The implant plate surface area implant is supero-temporal quadrant because of
is 350  mm2, and it has lateral wings that are more space available in this area. In case of scar-
designed to be placed under the rectus muscle. It ring in this region, the supero-nasal quadrant can
is a 35 mm silicon tube attached to a 13 mm con- be used for implant placement. The inferior
vex radius plate which conforms to the curvature quadrants are not preferred because of risk of
of the globe. It has additional holes to facilitate endophthalmitis. Before making a conjunctival
anchoring of the end plate to the sclera so as to incision, it is preferable to inject around 0.5 ml of
minimise device movement. There are various 4% xylocaine with adrenalin solution under the
surgical methods of implanting a glaucoma conjunctiva that aids both in haemostasis and
drainage device which have been elucidated in mechanical separation of the tissue from the
this chapter. sclera. Additionally, most of the eyes requiring

Electronic Supplementary Material  The online version


of this chapter (https://doi.org/10.1007/978-981-13-5773-
2_10) contains supplementary material, which is available
to authorized users.

S. Kumar (*)
Department of Ophthalmology, GMCH,
Chandigarh, India
S. Thakur
Department of Ocular Epidemiology, Singapore Eye Fig. 10.1  Corneal traction suture and dissection bleb
Research Institute, Singapore, Singapore raised using lignocaine

© Springer Nature Singapore Pte Ltd. 2019 67


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_10
68 S. Kumar and S. Thakur

implant surgery may already have scarred con-


junctiva that can undergo buttonholing with con-
ventional mechanical dissection; fluid-assisted
dissection using xylocaine/BSS can help in
avoiding this complication. A 9 to 12 o’clock or
12 to 3 o’clock hour peritomy is done depending
on the right or left eye that is to be operated.

10.3 AADI Implant


and the Extraocular Muscles Fig. 10.3  Both superior rectus and lateral rectus hooked

After the conjunctival incision, only minimal


cautery should be used to secure all bleeders in
the area where the implant is to be fixed and the
needle track is to be created. Excessive cautery
can lead to more scarring and irregular astigma-
tism later on. Using careful blunt dissection, the
bare sclera is then approached between the supe-
rior lateral rectus. Adequate posterior dissection
with tenotomy scissor will ensure proper place-
ment of the plate of the implant. The muscles are Fig. 10.4  AADI patency checked
then isolated from the surrounding tissue by a
cotton tipped applicator and then hooked using a the attachment of the plate. The tube occlusion
muscle hook. Surgeons should be careful while can be then tested using methylene blue dye. A
isolating these muscles as inadvertent damage to hydrating cannula is used to inject the dye, while
these muscles can later manifest as diplopia or serrated forceps hold the occluded tube. This con-
strabismus (Figs. 10.2 and 10.3) [2]. firmation of complete occlusion is vital as a
­partially occluded tube can result in early post-
operative hypotony. The implant is then slipped
10.4 AADI Preparation under the rectus muscles so as the wings are well
placed behind the muscle insertions. The plate is
The AADI needs to be primed before implanta- then anchored using 9-0 nylon sutures to the
tion. The patency of the tube is assessed using a sclera. An effective way is to use the 9-0 nylon
hydrating cannula (28 or 30 gauge) and balanced suture and make the needle pass through the sclera
salt solution (Fig. 10.4). Then the tube is ligated out through the hole on the implant on the tempo-
with 6-0/7-0 Vicryl suture around 2–3 mm from ral aspect and then take the same needle through
the nasal hole of the implant (without cutting the
suture) and out through the sclera. The suture is
then cut after assessing the length required to tie
secure knots which anchor the plate to the sclera.
Ideally the plate needs to be secured about 8 mm
away from the limbus. This provides sufficient
sclera ahead of the plate which can be subse-
quently used to anchor the tube or for scleral tun-
nel preparation. Additionally, it is preferable to
put plate anchoring sutures in the horizontal
direction to more effectively prevent side to side
Fig. 10.2  Preparation of supratemporal pocket movement of the implant (Fig. 10.5).
10  AADI Technique 69

10.5 Tube Placement Techniques

10.5.1 Scleral Tunnel

We avoid using scleral tunnels as they pose addi-


tional risk of inadvertent scleral perforation. The
scleral tunnel if attempted should start about
3–4  mm in front of the plate and extend about
4 mm short of the limbus. We advise putting an
anchoring suture using 9-0 nylon between the
Fig. 10.5  Implant fixation suture (8-0 nylon)
plate and the tunnel for additional tube stability.
About 1–1.5 mm away from the limbus, a nee-
dle (23-gauge) track is made into the anterior
chamber (AC). While withdrawing the needle
from the sclera, it is advisable to minimally extend
the entry of the track in the horizontal direction on
both sides with the help of needle to assist easy
entry of the tube (Fig. 10.6). Some surgeons pre-
fer to additionally push in a little viscoelastic via
this needle track to facilitate easy AC entry. It is
advisable to always measure the approximate
length of the tube using callipers before cutting
Fig. 10.6  Anterior chamber entry with 26G needle
the tube. The tip of the tube is cut with bevel-up
fashion and is made to insert the tube into the AC.
Any inadvertent tube track which is made and
not used should be sutured to prevent leak and
risk of post-operative endophthalmitis [2]. In
case of shallowing of the AC during insertion, a
paracentesis using a needle or 15° blade can be
made to reform the chamber. The tube is subse-
quently secured using 9-0 nylon sutures to the
sclera. The aim is to prevent micromotion of the
tube and subsequent extrusion from the AC. As
with Baerveldt-type implants, venting slits can be
made if immediate IOP control is required [3]. Fig. 10.7  Implant with ligating suture (6-0 vicryl)
They are made in the tube close to the limbus and
away from the occluding ligature with 1–2 small
punctures with a spatulated (10-0 nylon) needle
(Figs. 10.7 and 10.8).

10.5.2 Patch Grafts

As with Ahmed glaucoma valves, a variety of


graft materials can be used to cover the tube [4].
We prefer to use split thickness glycerine-­
preserved human cadaveric scleral patch grafts at Fig. 10.8 Fenestrations in tube proximal to ligation
our centre for covering the implant. Fresh scleral suture to aid in early IOP control after surgery
70 S. Kumar and S. Thakur

10.7 AADI in Paediatric


Population

Kaushik et  al. have successfully demonstrated


the use of AADI in patients with paediatric glau-
coma. They reported a cumulative success rate of
91.18% at 6 months and 81.7% at 18–24 months.
The mean number of topical anti-glaucoma med-
ications decreased from 3.1 ± 0.6 to 1.8 ± 1.3 at
Fig. 10.9  Partial-thickness scleral-patch graft sutured on 6 months and 1.6 ± 1.1 at 24 months (p < 0.001).
the tube They also did not report any tube erosion or
infection. They also compared their results to
published reports of the Baerveldt and AGV
implant and demonstrate AADI to have a similar
effectiveness and safety profile [5].

10.8 AADI in Pseudophakics,


Aphakics and PPKG

AADI implant has been used for a variety of


refractory glaucomas in pseudophakic/aphakic
Fig. 10.10  Conjunctival closure with 8-0 vicryl patients and also in eyes with post-penetrating
keratoplasty glaucoma (PPKG). In such eyes it is
grafts from corneo-scleral buttons preserved in wise to implant the tube in the ciliary sulcus. All
McCarey-Kaufman (MK) media can also be other steps of the surgery are performed as men-
employed for the same purpose. While using tioned above. Once the plate is secured and the
glycerine-preserved grafts, serial washing away tube ligated, a 23-gauge needle is used to make
of the glycerine is imperative before use. the track into the ciliary sulcus 2–2.5 mm away
A 3 × 3 mm graft is usually sufficient for cov- from the limbus. It is vital to visualise the needle
ering the tube (Fig. 10.9). The biomechanical and in pupillary area behind the iris for confirming
tectonic stability offered by the scleral tissue has the entry in the ciliary sulcus. During insertion of
given us good results. Additionally, the use of the tube in the ciliary sulcus, it is advisable to cut
partial-­thickness scleral-patch graft reduces the the tube at a longer length where the tube is just
chances of formation of extremely elevated blebs visible at the pupillary rim in an undilated pupil.
near the limbus that can potentially lead to delen It is also essential to push in a little viscoelastic
formation and ocular surface disease. Clear cor- via the needle track created to prevent collapse of
neal grafts and pericardial and fascia lata grafts this tract. Rest of the steps are similar to the tech-
can also be used similarly to cover the tube. nique described above. The implantation of the
tube in the ciliary sulcus eliminates the chances
of tube-endothelial touch and subsequent decom-
10.6 Conjunctival Closure pensation of the cornea in PPKG.
Bayer et al. have recently demonstrated that a
The conjunctiva is closed in running fashion glaucoma implant can control IOP whether placed
using an 8-0 Vicryl round bodied suture, without in the anterior chamber or the ciliary sulcus. The
tension. It is a good practice to administer a sub- ciliary sulcus group in their study had a higher
conjunctival injection of a combination of steroid IOP reduction ratio, decreased endothelial decom-
and antibiotic at the conclusion of the surgical pensation and reduced incidence of flat anterior
procedure (Fig. 10.10). chamber than the anterior chamber group [6].
10  AADI Technique 71

10.9 AADI in Post-vitrectomy Eyes devices, although during the initial few weeks,
AADI may require anti-glaucoma drugs to tide
AADI implant can also be used for glaucoma fol- over a period of raised IOP till Vicryl suture starts
lowing vitreo-retinal surgeries. The tube is degenerating. With new data being added every
implanted in the vitreous cavity, in eyes which day, AADI seems to be a good alternative for
have undergone complete vitrectomy. All other medically untenable glaucomas that require sur-
steps of the surgery are performed as mentioned gical intervention.
above. Once the plate is secured and the tube
occluded, a 23-gauge needle is used to make an
oblique bevelled entry into the vitreous cavity 10.12 Intraoperative Nightmares
4 mm away from the limbus. The needle is used and Their Management
to slightly extend the opening so that the tube can
be easily slid into the sclerostomy. The tube is • Conjunctival buttonholing: Identify and suture
then trimmed and then slid into the sclerostomy with 8-0 vicryl.
wound. Approximately, 4–5  mm length of the • Rectus muscle damage/disinsertion: Suture
tube is left in situ. A 10-0 nylon suture is passed the muscle to its insertion with 6-0 Vicryl to
in a purse-string fashion to secure the tube to the prevent lost muscle.
sclera. A patch graft is then used to cover the • Scleral tear while suturing/scleral tract forma-
entry of the tube into the sclera, and it is sutured tion: Suture with 6-0 Prolene; vitreous leaks
with 10-0 nylon sutures. The remaining tube is may require cutting of the vitreous, cryo-­
anchored to the sclera with 9-0 nylon sutures. application to the area of perforation and use
The tube position can be visualised after dilation of scleral patch graft. Retinal evaluation must
using indirect ophthalmoscope post operatively. be done later on for any retinal breaks or reti-
nal detachment.
• Intraoperative hyphema: Always remove the
10.10 A
 ADI in Eyes Prone blood in AC as it may lead to occlusion of
to Develop Uveal Effusion lumen of the tube in the post-operative period.
• Inadvertent shortening of the tube: The
It is advisable to prepare sclerotomies in infero- implant can be moved forward by 2 mm, and
nasal quadrant that allow choroidal drainage in additional tube length can be acquired.
such high-risk eyes which otherwise are very dif- • Long tube: On table can be easily corrected.
ficult to manage postoperatively. Post-operatively may require anterior
approach using Vanna’s scissors.
• Flat AC: AC can be reformed using BSS or
10.11 Advantages of the AADI viscoelastic. It is imperative to wash out the
viscoelastic at the end of the surgery; other-
AADI is a boon for resource-starved countries in wise post-operative IOP spike will be there.
Asia like India that have a huge burden of refrac- • Post-operative high IOP: Being a non-valved
tory glaucoma. Due to its $50 cost and being 5 implant AADI implantation requires the
times cheaper than AGV and 15 times cheaper patient to be maintained on anti-glaucoma
than Baerveldt, the switch to AADI seems obvi- drugs till the implant becomes functional after
ous [5]. It also has a larger surface area and seems 4–6 weeks.
to give lower IOP in the long term as compared to • Careful post-operative monitoring can help
valved devices. As the tube is occluded for the optimise anti-glaucoma drug use in AADI
first 4–6  weeks, the subconjunctival space and patients. We usually follow up the patient on
implant are not exposed to the inflammatory first post-operative day, after 1  week, two
mediators and theoretically have a lesser chance weekly follow-up till implant is fully func-
of bleb encapsulation. Therefore, there is no typi- tional (8–12 weeks) and two monthly follow-
cal hypertensive phase as in the case of valved ­up for 6 months.
72 S. Kumar and S. Thakur

References and fenestration used in Baerveldt aqueous shunts


for early postoperative intraocular pressure control. J
Glaucoma. 2002;11(1):65–70.
1. Gowri Priya C, Sivakumar K, Pillai M, Krishnadas
4. Thakur S, Ichhpujani P, Kumar S.  Grafts in glau-
SR, Sriram R, Muthukkaruppan V.  Evaluation of
coma surgery: a review of the literature. Asia Pac J
surface free energy of Aurolab Aqueous Drainage
Ophthalmol (Phila). 2017;6(5):469–76.
Implant (AADI) and its influence on cell adhesion
5. Kaushik S, Kataria P, Raj S, Pandav SS, Ram J. Safety
property, in comparison with Baerveldt implant.
and efficacy of a low-cost glaucoma drainage device
Invest Ophthalmol Vis Sci. 2013;54(15):4475.
for refractory childhood glaucoma. Br J Ophthalmol.
2. Riva I, Roberti G, Oddone F, Konstas AGP,
2017;101(12):1623–7.
Quaranta L.  Ahmed glaucoma valve implant: surgi-
6. Bayer A, Onol M. Clinical outcomes of Ahmed glau-
cal technique and complications. Clin Ophthalmol.
coma valve in anterior chamber versus ciliary sulcus.
2017;11:357–67.
Eye (Lond). 2017;31(4):608–14.
3. Kansal S, Moster MR, Kim D, Schmidt CM Jr, Wilson
RP, Katz LJ.  Effectiveness of nonocclusive ligature
Glaucoma Drainage Devices
in Special Cases 11
Sirisha Senthil

11.1 Introduction Molteno, (AADI), Aurolab Aqueous drainage


device) are defined as those that are passive and
Glaucoma is a leading cause of irreversible blind- do not offer any resistance to either anterograde or
ness worldwide. Treatment for glaucoma includes retrograde flow. Valved (Ahmed, Krupin, Joseph,
the use of eye drops, laser treatments and a vari- OptiMed, White shunt pump) devices offer a cer-
ety of surgical procedures. The current standard tain resistance and allow unidirectional flow of
as an initial surgical procedure for glaucoma is aqueous. Valved implants when installed have
trabeculectomy. Glaucoma drainage devices immediate function, whereas non-­valved designs
(GDD) are used when medical, laser and con- are typically restricted by a variety of temporary
ventional filtering surgery fail. During the past flow-restricting methods like absorbable suture,
few decades, GDDs have become an accepted supramid suture for tube occlusion (to prevent
alternative to other surgical procedures, even as immediate hypotony) which starts draining aque-
a primary surgery. They are useful especially ous usually after 4–6 weeks [3].
in managing complicated glaucomas for which
standard glaucoma surgeries carry high risk of
failure. They have been successful in controlling 11.1.2 Indications
IOP in a variety of glaucomas [1].
The following are the indications for glaucoma
drainage devices:
11.1.1 Types of Implants
• Glaucomas where conventional filtering sur-
Two basic types of implants are available, flow geries have failed.
restrictive (valved) and non-flow restrictive (non- • Refractory childhood glaucomas.
valved) [1, 2]. Non-valved devices (Baerveldt, • Neovascular glaucoma and traumatic glau-
coma as a primary procedure or following a
failed filter.
Electronic Supplementary Material  The online version
of this chapter (https://doi.org/10.1007/978-981-13-5773- • Aphakic glaucoma, pseudophakic glauco-
2_11) contains supplementary material, which is available mas, glaucoma following corneal transplant
to authorized users. and vitreoretinal surgeries.
S. Senthil (*) • Uveitic glaucomas with marked variations in
Glaucoma Services, LV Prasad Eye Institute, IOP, tubes work better than trab.
Hyderabad, India • Glaucoma in aniridia, Sturge-Weber syndrome
e-mail: sirishasenthil@lvpei.org
and ICE syndrome.
© Springer Nature Singapore Pte Ltd. 2019 73
M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_11
74 S. Senthil

• Glaucoma in eyes with lid abnormalities, be possible, and glaucoma drainage implants
ulcerative blepheritis, ocular surface disease. with posterior subconjunctival drainage have a
definite role to play. Placing an implant in these
eyes is technically challenging due to the space
11.2 Surgical Success constraint, this along with the complexity of
the glaucoma makes it one of the most difficult
Systematic review of reliable literature on glau- glaucomas to manage. The complications related
coma drainage devices has shown that the over- to improperly placed implant and inadequate
all success rates range between 60 and 90% in conjunctival closure can be devastating and
a period of 12–27  months after surgery, with a can lead to serious sight-threatening problems.
yearly failure rate of 10% in subsequent years, Preoperative planning, various modifications in
irrespective of the type of implant used [1]. the surgical technique and meticulous surgery
Complications such as hypotony and supracho- can help in successful management of these com-
roidal haemorrhage are comparable for the dif- plex glaucomas.
ferent devices, although a higher percentage of Various modifications of the surgical technique
diplopia occurred after use of the larger Baerveldt and the implants are described in literature with
implants [4]. both valved and non-valved implants [7–10]. Most
There is also insufficient evidence to conclude important preoperative planning includes choos-
that outcomes of trabeculectomy differ substan- ing the right location for the implant placement.
tially from implants in patients with complicated The extent, position and height of the buckle help
glaucomas [5]. The Tube versus Trabeculectomy to decide the site of placement of the GDD. It is
study that compared Baerveldt 350 with trab- better to avoid the quadrant in which the buckle
eculectomy with mitomycin C revealed a lower is anteriorly placed due to the difficulties in fix-
failure rate in the tube group (4% vs. 13%) at ing the plate. In an anteriorly located belt buckle,
the end of 1  year. However there was a greater GDD can be fixed 8 mm from the limbus (behind
need for topical antiglaucoma medications (1.3 the buckle); in posterior buckle, the implant can
vs. 0.5) in the tube group. The mean IOP values be placed over the encircling band and sutured to
were similar for the two groups (12.4 mmHg vs. the capsule or the buckle itself. In the presence of
12.7 mmHg) [6]. segmental buckle, it is better to choose a quadrant
where the episcleral band is absent. If the conjunc-
tival scarring is extensive, a paediatric implant is
11.3 A
 GV in Eyes with Post VR chosen or an adult implant can be trimmed appro-
Surgery Glaucoma priately to ensure adequate and free conjunctival
closure. It is better to avoid dissection in areas with
Management of refractory secondary glaucoma thin sclera and avoid excising the buckle or dis-
following vitreoretinal surgeries is a challenge. turbing the buckle. Good preoperative IOP control
These complex glaucomas are increasing due to is mandatory.
advancement in surgical techniques and retinal If conjunctiva is scarred, conjunctival relax-
surgeons operating complex retinal pathologies, ing incisions would help better surgical exposure
which were otherwise deemed inoperable. The [4]. Meticulous conjunctival dissection should
glaucoma associated with vitreoretinal surgeries be carried out to avoid buttonholes or conjunc-
is multifactorial and often refractory to medical tival tears. Both valved and non-valved devices
treatment. The challenge is even bigger if these have a role to play in these situations [7–10].
eyes with severe conjunctival scarring, encir- These eyes are more prone to complications
cling episcleral buckle and retained silicone oil related to implant/tube erosion and extrusion
in the eye. due to improper conjunctival closure or tissue
In eyes with multiple previous surgeries and necrosis or retraction [10]. Appropriate surgical
scarred conjunctiva, trabeculectomy would not modifications can help decrease serious implant-
11  Glaucoma Drainage Devices in Special Cases 75

related complication in these eyes. In eyes with tive procedures [18]. If there is severely scarred
no mobile conjunctiva, cyclodestructive proce- conjunctiva, trabeculectomy is avoided in favour
dures may be safer. of glaucoma drainage devices which offers good
prognosis.
In a study by Netland and others [15], glaucoma
11.4 Ahmed Glaucoma Valve drainage implants were found to effectively reduce
(AGV) with Boston the intraocular pressure in nearly all patients. The
Keratoprosthesis glaucoma drainage device is usually implanted
either prior to or concurrently with keratoprosthesis
When conventional keratoplasty is not possible or surgery. In the presence of preexisting glaucoma,
has high risk of failure, an artificial cornea or ker- AGV is performed prior to K-pro. In the presence
atoprosthesis may be used to replace the severely of preexisting glaucoma with severely scarred cor-
damaged or diseased cornea. Keratoprostheses nea precluding tube placement or visibility, then a
are made of clear plastic and have excellent tis- simultaneous K-pro and AGV are performed.
sue tolerance and optical properties. Some of the precautions taken for placing
Indications for Keratoprosthesis: Patients with implants in these eyes are appropriate location for
repeated graft failure, severe ocular surface dis- implant placement and choosing appropriate size
ease, severe corneal scarring with vascularization of the implant based on the health and mobility of
[11, 12]. the conjunctiva. Paediatric implants or trimmed
Advances in technique and the reduction adult implants can be used in the presence of
in incidence of endophthalmitis have together severely scarred conjunctiva. Meticulous surgery
improved patients’ prognosis following kerato- is needed to prevent tube or plate-related compli-
prosthesis surgery [13, 14]. However, in some cations [19]. The length of the tube to be placed in
patients with keratoprosthesis, one of the major the anterior chamber should be adequate so that
long-term complications is glaucoma [15, 16]. it can be seen through the central optical cylinder
Successful management of glaucoma is essential of the keratoprosthesis. Postoperative assessment
to preserve the vision in all such patients. of IOP is by digital estimation, stereoscopic disc
Detection of glaucoma and its management evaluation and visual field evaluation periodi-
following keratoprosthesis implantation surgery cally every 2–3 months.
can be a challenge. The usual line of management Glaucoma in keratoprosthesis is a serious
of glaucoma through monitoring the intraocular long-term complication which can lead to irre-
pressure cannot be pursued in these eyes, as intra- versible loss of vision. Managing glaucoma in
ocular pressure cannot be accurately assessed in such eyes is a challenge. Glaucoma drainage
eyes with keratoprosthesis. Digital palpation is implants may be used to effectively reduce the
one of the more reliable options for intraocular intraocular pressure in a majority of patients.
pressure measurement in the eyes with kerato-
prosthesis, as none of the currently available
IOP measuring devices can measure intraocular 11.5 G
 DD in Refractory Paediatric
pressures in the absence of normal cornea [17]. Glaucomas
In the absence of reliable pressure readings, how-
ever, one has to rely mostly on optic nerve head Congenital glaucoma is a potentially blinding
assessment and serial visual field examination for disease that is refractory to medication treatment.
glaucoma diagnosis and follow-up. Also, medical In paediatric glaucoma, the mainstay of treat-
treatment of glaucoma in these eyes with artifi- ment is surgical, and antiglaucoma medications
cial cornea or absent cornea is not an option, and are used as an adjunct to control the IOP when
treatment of glaucoma is essentially surgical. the child is waiting for surgery [20, 21].
Surgical management may be accomplished The surgical procedures for congenital glau-
by glaucoma drainage implants or cyclodestruc- coma are trabeculotomy, goniotomy, or com-
76 S. Senthil

bined trabeculotomy-trabeculectomy. Combined Challenges with implantation of GDD in


trabeculotomy-trabeculectomy is our preferred children:
surgical choice to manage primary congenital Children with congenital glaucoma have large
glaucomas. Though the procedure is associated globes for the orbit size with thin and stretched
with good early success rates, about 20% or 1/15 sclera. This poses a challenge in implanting a
of the surgeries fail at the end of 1 year [22]. The large drainage device in the posterior subcon-
surgical success decreases over time due to rapid junctival space. Another important issue is that
wound healing response and excessive scarring the child’s eye grows rapidly which leads to tube
in children. Secondary congenital or develop- retraction. So a longer tube has to be left in the
mental glaucomas associated with anterior seg- anterior chamber. However, tube corneal contact
ment dysgenesis, aniridia have poorer success or tube lenticular contact is a problem when a
rates. longer tube is left in the anterior chamber. A lon-
Glaucoma drainage devices are important ger subconjunctival tube with a sinuous course
alternatives in the management of these refrac- is an option in these eyes. The tube-related prob-
tory congenital glaucomas, especially when lems are more in children due to eye rubbing.
the filtering surgery has failed. When a 1° Therefore a good clinical judgement is manda-
trabeculotomy-­trabeculectomy fails, the surgical tory while deciding on the adequate length of
options available are repeat trabeculotomy with the tube in the anterior chamber (depending on
mitomycin C, glaucoma drainage devices and the pupillary size and the presence of other iris/
transscleral cyclophotocoagulation. corneal abnormalities). Larger implants and large
Trabeculectomy with mitomycin C has suc- blebs can cause motility disturbances in children
cess rates ranging from 48 to 95%, but the long-­ and may also lead to extrusion of the implant.
term risk of bleb-related problems is more and is With adequate with meticulous preoperative
serious [23–25]. planning and appropriate intraoperative precau-
Transscleral diode laser cyclophotocoagu- tions, the success rates of GDDs are good. Both
lation—TSCPC is easy to perform, but the valved and non-valved implants have similar
intraocular pressure control is unpredictable. success rates; however, the higher rates of hyper-
Vision-threatening complications like retinal tensive phase are noted in children with valved
detachment and phthisis bulbi have made these implants, and need for antiglaucoma medications
procedures less acceptable, especially if there is is higher. However, with non-valved implants, the
a visual potential. However, in eyes with poor/ IOP control is better, lesser hypertensive phase
or nil visual potential or if the 2nd/3rd surgery and lesser number of antiglaucoma medications
fails or/if there is a chance of anaesthetic com- needed. However the hypotony-­related complica-
plication, then a limited transscleral diode laser tions are higher with these implants. Hence it is
cyclophotocoagulation TSCPC can be conducted the discretion of the treating surgeon to choose
[26–28]. the type of implant based on the indication, risk
Glaucoma drainage devices: The success of factors and surgeons’ experience [29–31].
GDD has increased due to better implant models
and materials and less complications with surgi-
cal training and expertice [29–31]. 11.6 Summary
The indications are:
Glaucoma drainage devices are valuable options,
• Failed conventional surgery for primary con- and sometimes the only option in complicated glau-
genital glaucoma. comas especially when trabeculectomy with antifi-
• Secondary glaucomas like Sturge-Weber syn- brotic agents has failed. In some situations like those
drome, pseudophakic/or aphakic glaucoma, with scarred conjunctiva, neovascular glaucoma,
anterior segment dysgenesis, aniridia or post traumatic glaucomas and refractory paediatric glau-
penetrating keratoplasty glaucoma. comas implant surgery may be a primary option.
11  Glaucoma Drainage Devices in Special Cases 77

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soft contact lenses as an adjunct to the Boston kerato-
they have been demonstrated to effectively lower prosthesis. Int Ophthalmol Clin. 2008;48:43–51.
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16. Chew HF, Ayres BD, Hammersmith KM, Rapuano CJ,
Laibson PR, Myers JS, et al. Boston keratoprosthesis
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17. Birnbach CD, Leen MM. Digital palpation of intraocu-
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No: CD004918. https://doi.org/10.1002/14651856. A.  Mitomycin C-augmented trabeculectomy in
CD004918.pub2. refractory congenital glaucoma. Ophthalmology.
6. Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, 1997;104:996–1001.
Brandt JD, Budenz DL.  Treatment outcomes in the 24. Al-Hazmi A, Zwaan J, Awad A, al-Mesfer S, Mullaney
tube versus trabeculectomy study after one year of PB, Wheeler DT. Effectiveness and complications of
follow-up. Am J Ophthalmol. 2007;143(1):9–22. Mitomycin C use during pediatric glaucoma surgery.
7. Smith MF, Doyle JW, Fanous MM.  Modified aque- Ophthalmology. 1998;105:1915–20.
ous drainage implants in the treatment of complicated 25. Beck AD, Wilson WR, Lynch MG, Lynn MJ, Noe
glaucomas in eyes with pre-existing episcleral bands. R. Trabeculectomy with adjunctive mitomycin C in pedi-
Ophthalmology. 1998;105:2237–42. atric glaucoma. Am J Ophthalmol. 1998;126:648–57.
8. Scott IU, Gedde SJ, Budenz DL, Greenfield DS, 26.
al Faran MF, Tomey KF, al Mutlaq
Flynn HW Jr, Feuer WJ, et  al. Baerveldt drainage FA. Cyclocryotherapy in selected cases of congenital
implants in eyes with a pre-existing scleral buckle. glaucoma. Ophthalmic Surg. 1990;21:794–8.
Arch Ophthalmol. 2000;118:1509–13. 27. Phelan MJ, Higginbotham EJ.  Contact transscleral
9. Latina MA, Gulati V.  A modification of the Ahmed Nd: YAG laser cyclophotocoagulation for the treat-
valve for tight places. Ophthalmic Surg Lasers ment of refractory pediatric glaucoma. Ophthalmic
Imaging. 2003;34:396–7. Surg Lasers. 1995;26:401–3.
10. Choudhari NS, George R, Shantha B, Neog A,
28. Alvarado JA. Endocyclophotocoagulation for pediatric
Tripathi S, Srinivasan B, Vijaya L. Ahmed glaucoma glaucoma: a tale of two cities. J AAPOS. 2007;11:10–1.
valve in eyes with preexisting episcleral encircling 29. Chen TC, Bhatia LS, Walton DS. Ahmed valve surgery
element. Indian J Ophthalmol. 2014;62(5):570–4. for refractory pediatric glaucoma: a report of 52 eyes.
11. Aldave AJ, Kamal KM, Vo RC, Yu F. The Boston type J Pediatr Ophthalmol Strabismus. 2005;42:274–83.
I keratoprosthesis: improving outcomes and expand- 30.
Dave P, Senthil S, Choudhari N, Garudadri
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Combined Surgeries: Glaucoma
Drainage Devices and Cataract 12
Sagarika Patyal, Santosh Kumar,
and Suneeta Dubey

12.1 Introduction 12.2 Advantages


and Disadvantages
Cataract accounts for 50–80% of the bilateral of a Combined Surgery
blind in India with an annual incidence of two
million cases of cataract-induced blindness [1– Combined procedure is advantageous for both
3]. Both cataract and glaucoma commonly coex- the patient and surgeon. The patient needs to
ist and often need to be tackled together [4]. undergo surgery only once, with restoration of
Cataract may be present in a patient suffering both vision and control of intraocular pressure.
from glaucoma due to the ageing process itself, as Requirement of medication also decreases for
a result of previous glaucoma surgery or as an glaucoma postoperatively. It also decreases the
effect of glaucoma medications. The decision to risks of anesthesia and additional stress of multi-
perform a staged procedure versus a combined one ple surgeries. A combined phacoemulsification
is based on the extent of the two coexistent condi- and glaucoma drainage device surgery has the
tions, the surgeon’s preference, and presence of theoretical advantage of improving both vision
other factors specific to the individual patient. and IOP control, without the high risk of failure
as in trabeculectomy and the risk of
trabeculectomy-­related blebitis.
For the surgeon, it is a boon to be able to
assess the optic nerve and visual fields postopera-
tively. The surgical advantage of a combined pro-
cedure with a glaucoma drainage device is the
Electronic Supplementary Material  The online version ease of placement of the tube in the anterior
of this chapter (https://doi.org/10.1007/978-981-13-5773-
2_12) contains supplementary material, which is available
chamber or the sulcus during the cataract
to authorized users. surgery.
However combined procedure may increase
S. Patyal (*)
Centre of Sight, New Delhi, India the risk of postoperative complications like shal-
low anterior chamber, choroidal effusion/hemor-
S. Kumar
INHS Asvini, Mumbai, India rhage, and infection. Patients may require more
intensive postoperative medication than with
S. Dubey
Department of Ophthalmology, Dr Shroff’s Charity cataract extraction alone. The visual recovery is
Eye Hospital, New Delhi, India also longer than with cataract surgery.

© Springer Nature Singapore Pte Ltd. 2019 79


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_12
80 S. Patyal et al.

The surgery itself may be challenging due to Failed trabeculectomy is the most common
coexisting morbidities like neovascularization, indication for the combined surgery [5].
zonular weakness, poor visibility, and inadequate (h) Has been tried in phacomorphic glaucoma
dilatation of pupil. [10].

12.3 Indications for Combined 12.4 Technique of Combined


Cataract with Glaucoma Surgery of Tube Implant
Drainage Devices with Phacoemulsification
with IOL Implantation
Trabeculectomy is still considered the gold stan-
dard surgical treatment of glaucoma; however, 1. Surgery is performed with all aseptic precau-
glaucoma drainage devices (GDDs) have come to tions under peribulbar/general anesthesia.
occupy a special place in the treatment of refrac- 2. Phacoemulsification is performed in a stan-
tory glaucomas [5]. Glaucoma drainage devices dard conventional manner. All the incisions
are usually chosen in patients where the conven- (side ports/main port) are to be sutured in a
tional filtering surgery is likely to fail. However, water tight manner in combined surgery to
they are increasingly being opted for as a primary prevent leakage of wound.
choice too in certain patients [6–8]. 3. The tube implant surgery can be performed
after performing phacoemulsification, and
(a) Visually significant cataract in a patient IOL insertion or the plate of the implant can
requiring more than three antiglaucoma med- be fixed first followed by phacoemulsifica-
ications to maintain adequate intraocular tion and then the tube of the implant can be
pressure control [9]. inserted into the appropriate position.
(b) Patient is unable to tolerate the side effects of 4. For tube implant surgery, superior rectus
the antiglaucoma drugs or has systemic con- bridle suture or corneal traction suture is
traindications to their use. applied for better exposure of the surgical
(c) Patient, one eyed with advanced glaucoma in site as per surgeon’s preference.
that eye, may benefit from a single combined 5. Peritomy and blunt dissection of the con-
surgery. junctiva are either fornix or limbus based,
(d) Presence of significant risk factors like angle again depending on the surgeon’s choice.
recession and pigment dispersion syndrome 6. We prefer fornix-based conjunctival inci-
where conventional surgery is likely to fail. sion, which is created by making an incision

(e) Inability of the patient to tolerate two through the conjunctiva at the limbus extend-
surgeries. ing 4–6 clock hours of limbus circumfer-
(f) Preferred modality in patients with visually ence. A relieving incision is then made
significant cataract associated with any of the parallel to upper border of medial rectus or
following conditions: presence of uveitis, lateral rectus muscle depending on which
neovascular glaucoma, and traumatic glau- quadrant the implant is to be inserted (quad-
coma are known to be less likely to improve rant of tube implantation depends on mobil-
with trabeculectomy. ity of conjunctiva, location of preexisting
(g) Eyes with failed prior trabeculectomy, sclera implants if any, depth of anterior chamber,
buckling, or vitrectomy which may be asso- and/or presence of peripheral anterior syn-
ciated with conjunctival scarring, with sig- echiae). The dissection extends posteriorly
nificant cataract, and with uncontrolled for about 10–12 mm. A pocket is made for
intraocular pressure may also benefit from insertion of tube implant. Tenon’s capsule (if
combined cataract with AGV implantation. thick) can be dissected.
12  Combined Surgeries: Glaucoma Drainage Devices and Cataract 81

Limbus-based flap is created by making 17. Anterior part of the tube is covered with a
an incision through the conjunctiva at least donor scleral patch graft, which is fixed to
8 mm posterior to limbus. the sclera with a 9-0 nylon suture. If a lamel-
For nasal quadrant implantation, the ante- lar scleral flap has been made, then the tube
rior edge of plate to be positioned no more must be covered by the scleral flap, the cor-
than 8  mm from the limbus to avoid com- ners of which are sutured to the sclera.
pression on optic nerve by the posterior edge 18. The conjunctiva is closed with 8-0 vicryl
of the device. suture. The conjunctival closure should be
7. For bloodless field, wet field cautery may be water tight, and any leaks can be checked
done if required. using 2% fluorescein dye.
8. Before fixing the plate, the valve of the implant 19. Subconjunctival antibiotics and steroids are
is primed with 1  cc balanced salt solution given at the end of the surgery.
(BSS) using a 30-gauge cannula. BSS should 20. Postoperatively, intensive topical steroids,

be seen to flow through the valve to ensure that antibiotics, and cycloplegics are prescribed.
it is open prior to insertion of the implant. Antibiotic drops are usually stopped 2 weeks
9. Plate of the implant is fixed to the sclera by postoperatively. Steroids are tapered over
passing the sutures through the holes in the 8–12 weeks.
front part of the plate with 9-0 nylon sutures.
10. Tube is shortened to the desired length with
its sharp bevel facing anteriorly to allow 12.5 Some Useful Tips
2–3 mm tube in anterior chamber, not touch-
ing the corneal endothelium. The surgery may be complicated due to poor dila-
11. Anterior chamber (AC) paracentesis wound tation of the pupil. This could be as a result of
is created. AC is formed with sodium hyal- chronic use of miotics, chronic angle closure, prior
uronate 1% to prevent collapse of AC. trauma, presence of synechiae, and chronic inflam-
12. To prevent the movement of the tube, a radial mation. Associated diabetes and pseudoexfolia-
groove is made in the sclera at the proposed site, tion may also lead to poor dilatation. A good
and the edges of the groove are retracted using preoperative assessment can help identify this. The
mild cautery or a 10/0 or 9/0 monofilament patient can be asked to stop the miotics prior to the
suture may be used to fix the tube to the sclera. surgery. Intraoperatively, the synechiae can be bro-
13. Tube of the implant is entered into the AC ken with an iris repositor or a cyclodialysis spat-
parallel to iris plane through the sclerostomy ula. Once the adhesions are broken, the viscoelastic
made with a 23-gauge needle. may help in achieving adequate dilatation.
14. In eyes with severe iridocorneal adhesions, Intercameral epinephrine 1:10,000 may be used to
the tube can be inserted in the ciliary sulcus. aid dilatation. If by all these means adequate dila-
In that case, entry should be made 1.5–2 mm tation is not achieved, one can do sphincteroto-
posterior to the limbus. During withdrawal mies, or use iris hooks, or Malyugin ring.
of needle, viscoelastic should be injected to Stretching of the pupil using Sinskey hook also
push the iris anteriorly and IOL posteriorly can be done.
to facilitate entry.
15. Tube is fixed to the sclera with 9-0 nylon
suture. 12.6 Literature Search
16. Sodium hyaluronate 1% is removed thor-

oughly from the AC, and the side ports are Cataract surgery, by conventional means of extra-
sutured in a water tight manner. The efficacy capsular cataract extraction and by phacoemulsi-
of tube implant is checked by injecting BSS fication, with Ahmed glaucoma valve has been
in AC. reported with good outcomes. [5, 10–15]
82 S. Patyal et al.

In a series of 15 eyes of long-standing phaco- Hoffman et al. [14] reported cumulative suc-
morphic glaucoma with almost 360° anterior cess rate of 89% at 18  months for a combined
synechia, combined surgery of extracapsular cataract surgery along with Baerveldt implant.
cataract extraction was performed in the supero- In Asian eyes, Chung et al. [15] reported a simi-
nasal quadrant with implantation of heparin-sur- lar success rate using both Ahmed glaucoma valve
face- modified PCIOL after AGV was implanted and Baerveldt drainage implant as a combined sur-
in the superotemporal quadrant between the gery with phacoemulsification. The Baerveldt
superior rectus and lateral rectus muscles [10]. implant was associated with higher rate of failure as
The authors reported good postoperative visual compared to the AGV in this study. But overall, they
outcome and control of IOP. reported that the combined procedure provided a
In a retrospective case review by Valenzuela good IOP control with visual rehabilitation.
et  al. [5], combined phacoemulsification and Cost factor is a limitation of wider use of AGV
AGV implantation was done in 35 eyes. The most in combination with phacoemulsification [12].
common indication was failed trabeculectomy
and a significant cataract. They performed clear
corneal phacoemulsification first, followed by the 12.7 Summary
AGV implantation. The corneal incision was
sutured with a 10-0 nylon. They recommended A comprehensive preoperative examination of the
putting a ligature near the tube-plate junction to patient can help in deciding whether a combined
reduce the aqueous flow and the pro-­inflammatory procedure of cataract and GDD will help achieve
mediators in the first few days. This would a good IOP control with a better visual outcome.
decrease the plate encapsulation and risk of early The patient can be saved the stress of multiple sur-
hypotony. The study reported a qualified success geries including the cost and post-op visits. The
rate of 89% for the control of IOP. Visual acuity combined surgery may offer the surgeon an easier
improved in 85% of the eyes. access to the tube placement. However, the surgi-
A combination of cataract extraction with cal procedure is long and does not obviate the
AGV and intravitreal fluocinolone acetonide was chances of complications. Thus, a meticulous
reported in patients with chronic noninfectious weighing of the pros and cons should be done
uveitis. This was found to be beneficial in con- before advising the combined procedure.
trolling the IOP and inflammation in these
patients [11].
A study conducted to compare the outcomes
of phacoemulsification combined with trabecu-
References
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IOP reduction. However, antimetabolites were Krishandas R, Manimekalai TK, Baburajan NP, et al.
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survey. Ophthalmology. 2003;110:1491–8.
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5. Valenzuela F, Browne A, Srur M, Nieme C, Zanolli M, 11. Chang IT, Gupta D, Slabaugh MA, Vemulakonda GA,
López-Solís R, Traipe L. Combined phacoemulsifica- Chen PP.  Combined Ahmed Glaucoma Valve place-
tion and Ahmed glaucoma drainage implant surgery ment, intravitreal fluocinolone acetonide implanta-
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Glaucoma. 2016;25:162–6. Glaucoma. 2016;25:842–6.
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Brandt JD, Budenz DL.  Treatment outcomes in the Gomez L, Castaneda-Diez R, Thomas R, Gil-­
tube versus trabeculectomy study after one year of Carrasco F. Achieving target pressures with combined
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Brandt JD, Budenz DL.  Tube versus trabeculec- lectomy. J Curr Glaucoma Pract. 2015;9(1):6–11.
tomy study group: three year follow-up of the tube 13. Nassiri N, Sadeghi Yarandi S, Mohammadi B,

versus trabeculectomy study. Am J Ophthalmol. Rahmani L.  Combined phacoemulsification and
2009;148(5):670–84. Ahmed valve glaucoma drainage implant: a retrospec-
8. Wilson MR, Mendis U, Smitj SD, Paliwal A. Ahmed tive case series. Eur J Ophthalmol. 2008;18(2):191–8.
Glaucoma valve implant vs trabeculectomy in the sur- 14. Hoffman KB, Feldman RM, Budenz DL, et  al.

gical treatment of glaucoma: a randomized clinical Combined cataract extraction and Baerveldt glau-
trial. Am J Ophthalmol. 2000;130(3):267–73. coma drainage implant: indication and outcomes.
9. Marchini G, Ceruti P, Vizzari G, Berzaghi D, Zampieri Ophthalmology. 2002;109:1916–20.
A.  Management of concomitant cataract and glau- 15. Chung A, Aung T, Wang J, et al. Surgical outcomes
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10. Das JC, Chaudhuri Z, Bhomaj S, Sharma P, Gupta refractory glaucoma with cataract. Am J Ophthalmol.
R, Chauhan D.  Combined extracapsular cataract 2004;137:294–300.
extraction with Ahmed glaucoma valve implantation
in phacomorphic glaucoma. Indian J Ophthalmol.
2002;50:25–8.
Glaucoma Drainage Devices
(Ahmed Glaucoma Valve) 13
in Penetrating Keratoplasty-­
Associated Glaucoma

Madhu Bhadauria

13.1 Introduction lectomy may not be able to control the IOP as


there is associated deformed anterior segment
Raised intraocular pressure (IOP) following pen- and inflammation. Most of the PK patients need
etrating keratoplasty (PKP) is the second most to wear contact lenses for better visual outcomes
common cause of graft failure and an impor- [3]. Contact lenses are not indicated following
tant cause of irreversible blindness. Therefore trabeculectomy due to constant rubbing of the
management of IOP may be required before, bleb by contact lens edge leading to leaks and
along with or after the patient has undergone subsequent bleb infection and endophthalmitis.
PKP. Irreversible visual loss is seen due to optic The raised bleb may lead to poor fit of contact
nerve damage, and graft failure is caused by lenses [4]. Glaucoma drainage devices offer a
persistent rise in IOP leading to chronic corneal better alternative as there is no bleb at the limbus,
endothelial damage leading to corneal oedema a good IOP control and a stronger eyeball. A tube
and compromised graft clarity [1]. placed in the posterior chamber or the pars plana
Post-penetrating keratoplasty glaucoma can prevent endothelial loss following a glau-
(PPKPG) by definition is an elevated intraocular coma drainage device surgery. Ahmed glaucoma
pressure (IOP) greater than 21 mmHg, after pen- valve has been found to be very useful in patients
etrating keratoplasty, with or without associated who have either preexisting glaucoma or develop
visual field loss or optic nerve head changes. It glaucoma following PK.
is not always possible to assess the disc or field
changes due to media opacity; hence, raised IOP
remains the hallmark for diagnosis [2]. PKPG 13.2 Incidence
may pose significant problem due to its higher
incidence, difficulty in diagnosis, monitoring Olson and Kaufman [3] retrospectively reviewed
and challenges in its management. It is often their patients after aphakic keratoplasty or com-
refractory to medical therapy; standard trabecu- bined cataract extraction with PK to determine
the frequency of persistently increased IOP.  In
their study, 37 of 81 eyes (46%) had an IOP
Electronic Supplementary Material  The online version >35  mmHg in the first postoperative week, and
of this chapter (https://doi.org/10.1007/978-981-13-5773-
2_13) contains supplementary material, which is available 28 of these (35%) were being treated with glau-
to authorized users. coma medications 6 months after surgery. Seven
eyes (19%) required cyclocryotherapy to control
M. Bhadauria (*) the pressure. Patients with preoperative raised
RIO Eye Hospital, Sitapur, Uttar Pradesh, India

© Springer Nature Singapore Pte Ltd. 2019 85


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_13
86 M. Bhadauria

IOP or high IOP during the first postoperative as well as making patient unfit for contact lens.
week were more likely to have persistent post- The use of antimetabolites has been associated
PK glaucoma [5]. In other studies, incidence of with severe intraocular infections leading to pro-
glaucoma following PKP is reported to be 9–31% found visual loss [11]. Hence glaucoma drainage
in the early postoperative period and 18–35% in devices (GDDs) may provide a safer alternative.
the late postoperative period [6, 7]. They are composed of a silicone tube attached
to a flat plate that is sewn to the sclera. Aqueous
flows from the eye through the tube onto the
13.2.1 Risk Factors plate to form a sub-­tenon bleb. Early postopera-
tive hypotony is avoided by a valve (as in the
The risk factors for developing glaucoma after Ahmed implant) or through an occluding liga-
PKP: ture or stent that dissolves or is removed some
4–6 weeks postoperatively.
1. Preexisting glaucoma
2. Aphakia
3. Anterior segment inflammation 13.3 Pre-AGV Patient Workup
4. Corneal diagnosis (herpes simplex, Fuchs’

dystrophy, ICE, keratitis, PBK, ABK, trauma) Many of the risk factors outlined above can
5. Intraocular lens removal be screened preoperatively, with a glaucoma-­
6. Vitrectomy oriented ophthalmic examination. Standard eval-
7. Post-keratoplasty/extracapsular cataract uation consists of recording of visual acuity, tear
extraction/intraocular lens film evaluation, lid closure and detailed slit lamp
examination for presence of any anterior segment
anomaly or subtle inflammation. Examination of
13.2.2 Rationale for Using the pupil can give a good idea regarding preexist-
the Ahmed Glaucoma Valve ing glaucoma damage. Tonometry and a pupillary
examination can often identify previously unsus-
Medical management of PPKPG seems most pected glaucoma despite cloudy cornea. In pres-
convenient to the doctor as well as to the patient. ence of clear media, gonioscopy is a must to find
However, it is not really the best option in most out angle closure, peripheral anterior synechiae
of the patients who require more than one drug. or abnormal structures. In the patients with a
Beta blockers cause dry eye which is detrimental significant proportion of the angle obstructed by
to the health of ocular surface and may lead to anterior synechiae, post-­keratoplasty glaucoma
unhealthy epithelium and epithelial defects [8]. is a certainty, and tube in posterior chamber is a
Dorzolamide suppresses the endothelial pump safer alternative.
function leading to corneal oedema or thicker In presence of cloudy or opaque media,
cornea. Prostaglandins can cause inflamma- anterior chamber angle may be examined with
tion which leads to an immunogenic response anterior segment optical coherence tomography
hence may abet graft rejection. Activation of (OCT) [12] and/or ultrasound biomicroscopy
herpes due to prostaglandin use too can lead to (UBM) to determine the configuration of the
graft infection and failure. So far, only alpha anterior chamber angle peripheral synechiae and
agonists have no documented direct deleteri- other structures like lens haptic. It aids the sur-
ous effects. Topical medication can be used for geon in planning the site for a glaucoma drainage
a short duration, but for long term, drugs are device (GDD) [9].
not an appropriate choice due to their own side The presence of a large afferent pupillary
effect and effect of preservative on the ocular defect is an ominous sign. Visual fields are unre-
surface [9, 10]. Trabeculectomy too is associ- liable in the patient with hazy media and impos-
ated with complications leading to graft failure sible to perform in the presence of opaque media.
13  Glaucoma Drainage Devices (Ahmed Glaucoma Valve) in Penetrating Keratoplasty-Associated… 87

In evaluating patients with hazy media follow- 13.5 Technique


ing trauma, Fuller and Hutton [13] found that
flash visual evoked potential (flash VEP) was Anaesthesia-glaucoma drainage devices are usu-
the single best predictor of postoperative vision, ally implanted under local anaesthesia. Peribulbar
followed by bright flash electroretinogram and block is given using lignocaine and sensorcaine
ultrasonography. in ratio of 50% each along with 150  units of
It is practical to take fundus photographs at hyaluronidase. Neither external pressure nor
the first examination in patients with clear media adrenalin is used in the block to avoid ischaemia
and serially repeat them at least once a year to of optic nerve head in an already compromised
detect if there is any progression of the glauco- optic disc.
matous optic neuropathy.

13.5.1 Surgical Technique


13.4 IOP: Measurement
The penetrating keratoplasty is done as per the
IOP in the early postoperative period, when the corneal surgeons’ choice, and the sutures are
corneal surface is irregular, can be measured applied. The glaucoma drainage device is subse-
with the tono-pen. It has a small plunger and quently inserted. Some prefer to fix at the plate
a disposable cover for aseptic technique. The before the beginning of the surgery and before
dynamic contour tonometer (DCT) can be used the button is removed so as to fix in a firm eye.
as it has the advantage of not being dependent For the purpose of fixation, a superior rectus
on the corneal thickness [14]. If the graft sur- bridal suture or corneal traction suture is taken.
face is smooth, has an intact epithelium and if A fornix-based conjunctival flap is dissected
regular mires can be obtained, then Goldmann in one quadrant, usually a supero-temporal or
Applanation Tonometer can be used to measure infero-­temporal quadrant. Conjunctival flap is
the IOP. Marked corneal astigmatism causes an dissected meticulously to avoid button holing,
elliptical fluorescein pattern. To obtain an accu- and a deep enough pocket is dissected almost
rate reading with the Goldmann Applanation beyond the equator to house the silicone plate.
Tonometer, the clinician should rotate the prism If need be, vertical relaxing cuts may be given
so that the red mark on the prism holder is set at in tenon to create space for the plate. The valve
the least curved meridian of the cornea (along is primed using 30-gauze cannula to open the
the negative axis). Also, two pressure readings, valve mechanism as during storage, the flaps
taken 90° apart, can be averaged. The accuracy of the valve may have become firmly attached
of Goldmann Applanation Tonometry is reduced to each other. The plate is then sutured with 9/0
in certain situations, such as corneal oedema, nylon to the sclera, 7–9 mm away from the lim-
scars, blood staining or any condition that thick- bus between superior and lateral rectus. The tube
ens or alters the corneal elasticity [15]. Corneal is inserted into the anterior or posterior chamber
epithelial oedema and stromal oedema predis- or from the pars plana depending upon the surgi-
pose to inaccurately low readings. Pressure cal choice. A side port is made to inject fluid or
measurements taken over a corneal scar will be Healon to keep AC formed and firm all the time.
falsely high. Measuring IOP with Goldmann The tube needs to be covered to prevent erosion
Applanation Tonometer is standardized for a of the tube. For covering the tube, three methods
central corneal thickness (CCT) of 520  μm; could be used, a rectangular partial-thickness
thus, overestimation of IOP may occur due to scleral flap, suture-less partial-thickness scleral
an increase in the corneal thickness. The other tunnel, and donor sclera.
practical tonometer is I-Care rebound tonometer Partial-thickness scleral flap technique—In
which has only 1.8 mm contact and can be used this technique, a partial-thickness limbal-based
without anaesthesia. scleral flap measuring 5 mm × 5 mm is dissected.
88 M. Bhadauria

The entry into the anterior chamber is made using 13.5.3 Scleral Patch Graft Cover
23-gauze needle underneath the partial- thickness of the Tube
flap about 1 mm away from the posterior limbus.
The direction is chosen depending upon its loca- The technique is similar to the above, except that
tion anterior or posterior to the iris. Now, the tube no scleral flap or tunnel is made. Tube is covered
is made straight from its attachment to the plate with a scleral patch graft from the cadaver eye.
and measured so that about 2 mm of tube will be Suturing is done with 8 or 9/0 nylon, and the con-
in the anterior chamber or posterior chamber and junctiva is closed. This technique is extremely
cut on the distal end with a tapering intraocular useful when the sclera is thin and fragile due to
end. Posterior chamber is the preferred site as it multiple surgeries, collagen disorders and thin
prevents the tube cornea touch which may lead sclera in children. Scleral cover can also be used
to chronic endothelial loss progressing to corneal on top of the tunnel for thicker tube cover in case
decompensation. The tube is fixed to the sclera following surgery tube exposure is expected.
near the plate using 10/0 nylon suture on spatu-
lated needle. Then, partial-thickness scleral flap
is sutured with 10/0 nylon on the top of the tube 13.5.4 Pars Plana Tube Insertion
to cover it completely. The conjunctival flap is Technique
stretched to cover the entire area and is sutured
from end to end including the partial-thickness The tube can be inserted through the pars plana
bites on the clear cornea with 8/0 vicryl suture. only in the eyes which have undergone vitrec-
The aim is to prevent any exposure of overlying tomy. In case vitrectomy is done in the same sit-
sclera which may melt if left exposed. A well-­ ting, the tube is inserted from the same 23-gauze;
maintained anterior chamber with a little firm eye MVR port else in previously vitrectomized eyes
is the end point. a fresh port can be made with 23-gauze needle,
and the tube is inserted. The remaining tube is
covered with donor sclera, and the procedure is
13.5.2 Scleral Tunnel Technique [16] completed.

In this technique, instead of a scleral flap, a


partial-­
thickness scleral tunnel is dissected, 13.6 Postoperative Care
which is open at both ends. After fixing the valve
with the sclera, the tube is stretched forward to Postoperative care is the same as in all the cases
see the location of tube. After that tube is kept of AGV/GDD.  However, anti-corneal graft
away by tucking it in the speculum. Two inci- rejection protocol is started with the use of oral
sions measuring 2 mm are made parallel to the steroids in the dosage of 1  mg/kg. One hourly
limbus. The distance from the limbus is kept topical steroids and if required cycloplegics are
1 mm and 7 mm away. With the help of a scleral used with the aim to keep the inflammation and
tunnel blade, these two incisions are connected immune status of the eye to the least. The special
to each other at approximately half-thickness points which need to be taken care of are tube
deep scleral just like in SICS.  Now the tube is corneal touch, hypotony and shallow AC, immu-
shortened for 2  mm length in AC.  It is passed nogenic graft rejection and dellen formation
from 7  mm away incision to 1  mm incision due to high bleb. Tube corneal touch can lead to
and is exteriorized. A 23-gauze needle is then chronic endothelial loss leading to graft failure.
inserted into AC in phakic eyes and PC in apha- To prevent tube corneal touch, special care is
kic or pseudophakic eyes to create a wound of taken to use the correct direction and placement
entry for the tube. Then, the tube is inserted into of the tube. In case it is not so, a revision surgery
AC/PC. to reinsert the tube is indicated (Fig. 13.1).
13  Glaucoma Drainage Devices (Ahmed Glaucoma Valve) in Penetrating Keratoplasty-Associated… 89

Ahmed Glaucoma
Valve

• Tube in PC
• Bleb

Fig. 13.1  Postoperative pictures of the eye with penetrating keratoplasty and AGV. Note the bleb and the tube in pos-
terior chamber. Also shown are the parts of the AGV

Hypotony can lead to endothelial loss and important to manage both. Usually, hyperten-
graft failure. To prevent this, wound entry is kept sive blebs are high and congested, and steroid
tight fitted. Some Healon may be left in AC if responders will have less high and less raised
there is hypotony. If shallow AC occurs, prompt blebs [17]. True demarcation is really difficult. If
measures to correct it by using Healon injection the bleb is high and congested, we can keep the
in AC may be done. steroids on or can use something like betametha-
Corneal graft rejection can be initiated by any sone along with antiglaucoma medications. If
surgical or inflammatory insult to the cornea, and bleb is good, a very mild steroid like fluorometh-
AGV is a surgery; hence, we need to take pre-­ olone may be used with antiglaucoma medication
emptive steroid cover to prevent it. Following till such time IOP rise persists. Post-penetrating
this, a graft needs close watch for rejection. Early keratoplasty patients usually need some amount
signs of graft rejection may be masked due to ste- of steroid for a very long period of time. To pre-
roid cover, but meticulous search must be made vent hypertensive phase, it is may be wise to start
for Khodadoust line, localized graft oedema and antiglaucoma medication after 10–15 days even
KPs, especially close to sutures or blood vessel. if the IOP is normal. Very high blebs affect cor-
Early detection with aggressive treatment can neal wetting and may lead to dellen formation.
save the graft from failing. A high viscosity lubricant can be used to prevent
Steroid responders need to be watched care- dellen formation.
fully as steroid response and hypertensive phase Although GDDs demonstrate an excellent
of bleb commence at the same time, and it is rate of IOP control, the risk of corneal graft
90 M. Bhadauria

failure is high and may be even higher than in By the use of GDD, some patients may not
the eyes undergoing trabeculectomy. The high require any further treatment, but the number of
incidence of graft rejection following AGV is an glaucoma medications is significantly reduced
important matter, and the reported incidence has even in those patients who qualify to be success-
been between 15% and 41%. Kirkness describes ful. Hypertensive phase is seen in nearly 80% of
pathogenesis of graft rejection by the presence Indian eyes but gets controlled by steroids and
of a tidal flow of cells in and out of the tube antiglaucoma medications. Success rate has been
located in the AC leading to a possible con- found to be higher when the AGV or GDD is
tact of aqueous humour with circulating lym- either done before PK or simultaneously [25].
phocytes, through the drainage tube, and the Post PKPG patients are not only prone to graft
tube may also allow the retrograde passage of failure following AGV but also are less success-
inflammatory cells into the AC, increasing the ful in terms of IOP control.
risk of graft rejection [18]. The other mode of Many patients who need to undergo PK often
occurrence, as hypothesized, could be due to have glaucoma either before PK or develop glau-
an alteration of the blood-ocular barrier caused coma following PK.  It is prudent to do a good
by the GDD.  Studies show that graft failure glaucoma evaluation in all the patients who are
is maximum when GDDs are placed post PK likely to undergo PK so that glaucoma can be
[19]. This was attributed to corneal endothelial controlled before PK is done. In case of AGV,
trauma during GDD implantation which is more success rate in terms of IOP control is more if
relevant to post-PKPG eyes [20]. done before PK; it will be wise to do so as the
surgeon can do PK on a quite eye with low pres-
sure. AGV can be done simultaneously if IOP
13.7 Conclusion is not likely to be controlled on drugs follow-
ing PK. If glaucoma develops following PK and
Success rate following AGV in PKPG is tabled AGV is required, it should be done with all the
below as published in IJO [21]. The results of due care to avoid graft rejection or failure. Done
authors in the table are compared with IJO study properly, it is a good modality for long-term suc-
[19, 22, 23]. cess and reduction of antiglaucoma medications.

No. of Follow-up
Authors and year eyes (months) Definition of success (mmHg) Success rate (%)
Colemann et al. 16 9.3 IOP < 22 or reduction 78 (1 yr)
1995 [24] >20% if preoperative IOP > 22, IOP > 4 for
>2 months, no additional glaucoma surgery, no
visually devastating complications
Topouzis et al. 16 30.5 6 < IOP < 22 at last 2 visits, no additional 76 (1 yr)
1999 [25] glaucoma surgery, no visually devastating 68 (2 yrs)
complications, no loss of light perception, no 54 (3 yrs)
removal or replacement of AGV 45 (4 yrs)
Romaniuk et al. 17 12 Not available 73.5
2004 [20]
Present study 20 6 Absolute success was defined as 55
(Panda et al., 5 < IOP < 21 mmHg
2010) Qualified success was defined as 30% with
5 < IOP < 21 mmHg with medications or minor medication and
procedures 15% with additional
minor surgery
AGV Ahmed glaucoma valve, IOP intraocular pressure, PKP penetrating keratoplasty, yr year
13  Glaucoma Drainage Devices (Ahmed Glaucoma Valve) in Penetrating Keratoplasty-Associated… 91

13.8 Summary adjunctive mitomycin C or 5-fluorouracil treatment.


Br J Ophthalmol. 1997;81:877–83.
12. Fukuda R, Usui T, Tomidokoro A, Mishima K, Matagi
The success of the GDD is best when it is N, Miyai T, Amano S, Araie M. Noninvasive observa-
implanted before or concurrent with the PK. The tions of peripheral angle in eyes after penetrating kera-
lowest graft survival rate is seen when the GDD is toplasty using anterior segment fourier-domain optical
coherence tomography. Cornea. 2012;31(3):259–63.
implanted after the PK [24]. The placement of the 13. Fuller DG, Hutton WL.  Prediction of postop-
tube in the anterior chamber is associated with erative vision in eyes with severe trauma. Retina.
better graft clarity compared to the pars plans 1990;10:S20–34.
tube. However, there is lack of a randomised clin- 14. McMillan F, Forster RK.  Comparison of MacKay-­
Marg, Goldmann and Perkins tonometers in abnormal
ical study to compare the two sites. The choice corneas. Arch Ophthalmol. 1975;93:420–4.
of placement thus depends on the anatomy of the 15. Doughty MJ, Zaman ML.  Human corneal thickness
angle and status of lens and vitreous along with and its impact on intraocular measures: a review
the surgeons’ preference. and meta-analysis approach. Surv Ophthalmol.
2000;44(5):367–408.
16. Bhadauria M.  Sutureless and intra-scleral tube

implantation in Ahmed Glaucoma. https://www.
aao.org/annual...video/sutureless-intrascleral-tube-
References implantation-in-ahmed.
17. Nouri-Madhavi K, Caprioli J. Evaluation of the hyper-
1. Dunn SP, Gal RL, Kollman C, et  al. Corneal graft tensive phase after insertion of the Ahmed glaucoma
rejection 10 years after penetrating keratoplasty in the valve. Am J Ophthalmol. 2003;136:1001–8.
cornea donor study. Cornea. 2014;33:1003–9. 18. Kirkness CM, Ling Y, Rice NS.  The use of silicone
2. Lim MC, Brandt JD, Baik AK. Glaucoma after cor- drainage tubing to control post keratoplasty glau-
neal transplantation, Chapter 116. In: Mannis MJ, coma. Eye. 1988;2:588–90.
Holland EJ, editors. Cornea. Edinburgh: Elsevier; 19. Topouzis F, Coleman AL, Choplin N, Bethlem MM,
2017. p. 1338–54. Hill R, Yu F, et  al. Follow up of the original cohert
3. Wilson SE, Kaufman HE. Graft failure after penetrat- with the Ahmed Glaucoma Valve implant in eyes with
ing keratoplasty. Surv Ophthalmol. 1990;34:325–56. prior or concurrent penetrating keratoplasties. Am J
4. Pederson K.  Enhance postoperative filtering bleb-­ Ophthalmol. 1999;128:198–4.
induced vision difficulties with well-fitted GP 20. Kirkness CM, Ling Y, Rice NS.  The use of silicon
contact (oxygen-permeable) lenses. Optometry. drainage tubing to control post-keratoplasty glau-
2005;76(2):115–22. coma. Eye (Lond). 1988;2:583–59026.
5. Olson RJ.  Aphakic keratoplasty. Determining donor 21. Panda A, Prakash VJ, Dada T, Gupta AK, Khokhar
tissue size to avoid elevated intraocular pressure. Arch S, Vanathi M.  Ahmed glaucoma valve in post-­
Ophthalmol. 1978;96:2274–6. penetrating-­keratoplasty glaucoma: a critically evalu-
6. Bertelmann E, Pleyer U, Rieck P.  Risk factors for ated prospective clinical study. Indian J Ophthalmol.
endothelial cell loss post kertoplasty. Acta Ophthalmol 2011;59:185–9.
Scand. 2006;84:766–70. 22. Romaniuk W, Fronczek M, Szkaradek P, Dorecka

7. Kirkness CM, Moshegov C.  Post keratoplasty glau- M. Implantation of Ahmed-type valve in the treatment
coma. Eye. 1988;2:19–26. of glaucoma, following penetrating keratoplasty. Klin
8. Sherwood MB, Grierson I, Millar L, et  al. Long-­ Ocz. 2004;106:170–2.
term morphologic effects of antiglaucoma drugs on 23. Coleman AL, Hill R, Wilson MR. Initial clinical expe-
the conjunctiva and Tenon’s capsule in glaucomatous rience with the Ahmed glaucoma valve implant. Am J
patients. Ophthalmology. 1989;96:327–35. Ophthalmol. 1995;120:23–31.
9. Dada T, et al. Post-penetrating keratoplasty glaucoma. 24. Rapuano CJ, Schmidt CM, Cohen EJ, et  al. Results
Indian J Ophthalmol. 2008;56:269–77. of alloplastic tube shunt procedures before, dur-
10. Sihota R, Sharma N, Panda A, Aggarwal HC, Singh ing, or after penetrating keratoplasty. Cornea.
R.  Post penetrating keratoplasty glaucoma: risk fac- 1995;14:26–32.
tors, management and visual outcome. Aust N Z J 25. Al Torbak AA.  Graft survival and glaucoma out-
Ophthalmol. 1998;26:305–9. come after simultaneous penetrating keratoplasty
11. Mochizuki K, Jikihara S, Ando Y, et  al. Incidence and Ahmed glaucoma valve implant. Cornea.
of delayed onset infection after trabeculectomy with 2003;22:194–7.
Combined Surgeries:
Glaucoma Drainage Devices 14
with Boston KPro

Suneeta Dubey, Nidhi Gupta, Madhu Bhoot,


and Shalini Singh

14.1 Introduction rior plates. Boston keratoprosthesis is assembled


using the corneal graft which is sutured into the
The artificial cornea, or keratoprosthesis host rim like in penetrating keratoplasty.
(KPro), is a viable option for visual rehabilita- The major complications of B-KP I include
tion in patients not amenable to allotransplanta- tissue necrosis, glaucoma, posterior uveitis, and
tion. It includes patients with severe bilateral retroprosthetic membranes.
ocular surface disorders like chemical injury,
limbal stem cell deficiency, Stevens-Johnson
syndrome (SJS), and ocular cicatricial pemphi- 14.2 B-KP I and Glaucoma
goid (OCP).
The design of KPro has been evolving over the Glaucoma is one of the most common and chal-
years to incorporate the desired features since its lenging complications associated with B-KP I
introduction for the first time by Quengsy in surgery [1–3]. Various studies have shown a high
1789. Boston keratoprosthesis type I (B-KP I) is incidence of pre-existing glaucoma (36–76%) in
the most commonly implanted keratoprosthesis these patients, whereas many (2–28%) who do
worldwide. It has a “collar button” design which not have any signs of pre-existing glaucoma can
consists of a central stem with anterior and poste- develop raised IOP following KPro implantation
[4–8].

Electronic Supplementary Material  The online version


of this chapter (https://doi.org/10.1007/978-981-13-5773- 14.2.1 Pre-existing Factors
2_14) contains supplementary material, which is available Contributing to Glaucoma
to authorized users.
Candidates for B-KP I often have history of mul-
S. Dubey (*) · M. Bhoot
Glaucoma Services, Department of Ophthalmology, tiple corneal surgeries or have comorbidities that
Dr. Shroff’s Charity Eye Hospital, New Delhi, India can lead to damage to the angle structures result-
e-mail: suneeta@sceh.net ing in the development of glaucoma. Those with
N. Gupta multiple graft failures have extensive PAS lead-
Cornea Services, Department of Ophthalmology, ing to angle closure and raised IOP [9].
Dr. Shroff’s Charity Eye Hospital, New Delhi, India Inflammation and scarring of the drainage angle
S. Singh in SJS and chemical burns (alkali > acid) [10],
Retina Services, Department of Ophthalmology, whereas trabeculitis in Herpes simplex viral
Dr. Shroff’s Charity Eye Hospital, New Delhi, India

© Springer Nature Singapore Pte Ltd. 2019 93


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_14
94 S. Dubey et al.

keratitis may lead to development of glaucoma. 14.3.1 Role of Glaucoma Drainage


In patients with aniridia, iris stromal extensions Devices (GDD)
may block the angle structures contributing to
high IOP [11]. Most of the B-KP I patients require GDD implan-
tation to control glaucoma as trabeculectomy has
high failure rates due to multiple associated
14.2.2 Postoperative Factors comorbidities. Both valved and non-valved
Contributing to Glaucoma GDDs are widely used in clinical practice.
Ahmed glaucoma valve (FP7; New World
The major contributing factors for the develop- Medical, Rancho Cucamonga, CA, USA) is the
ment and progression of glaucoma are crowding GDD of choice in these patients as it is less space
of angle due to KPro back plate, obstruction of occupying, and there is less chance of hypotony
aqueous outflow due to inflammation and pig- postoperatively as compared to non-valved tube
ment dispersion [3], and blockage of angle by shunts [14, 15]. Position of the tube is an impor-
vitreous in aphakic patients [12]. Long-term use tant determinant of success of the procedure and
of steroids can also result in development of high depends on the type of KPro, status of the ante-
IOP in steroid responders. rior chamber angle, and the status of the lens.
Tubes may be implanted either in the anterior
chamber or ciliary sulcus with or without vitrec-
14.3 The Challenges tomy or through the pars plana with vitrectomy
[16, 17]. Pars plana tube placements offer many
IOP measurement in both pre and post KPro advantages in terms of better visual rehabilitation
eyes is a major challenge faced by clinicians. with improved contact lens fitting, lesser risk of
Preoperatively, it is difficult to measure IOP tube erosion, and less chance of obstruction of
because of corneal scarring and edema [12], tube caused by crowding within the anterior
and postoperatively, the presence of PMMA chamber. Huh et  al. combined PPV with GDD
optic and back plate poses a problem in mea- and KPro in a series of 20 eyes and reported good
surement of true applanation values. Digital control of IOP in 85% of their patients at
palpation by an experienced ophthalmologist is 31.6  months (±17  months) of follow-up with
presently the most preferred method for assess- lower rate of complications. None of the eyes in
ment of IOP [13]. Other techniques to measure their series had conjunctival erosion or showed
IOP at the limbus, like the pneumo-tonometer progression of glaucoma.
and tono-pen can also provide a rough estimate GDD can be implanted concurrently with
of the IOP. Optic nerve head evaluation is dif- KPro or in a staged manner in patients who have
ficult due to the corneal opacity, and visual high risk of development of glaucoma. The com-
fields may be unreliable or difficult to perform bined procedure results in restoration of optical
because of advanced glaucoma and associated clarity and IOP control in a single sitting, whereas
comorbidities. a staged procedure results in better control of IOP
A thorough preoperative evaluation is rec- postoperatively decreasing the occurrence of
ommended in patients undergoing KPro to glaucomatous optic neuropathy. The disadvan-
assess the need for glaucoma surgery. KPro tages of a staged procedure are the ambiguity of
placement without glaucoma surgical interven- the position of the tube as well as the cost and
tion is considered in patients with open angles risk associated with two procedures. Many stud-
without any history of glaucoma, whereas KPro ies have placed GDD simultaneously with KPro
placement with glaucoma surgical intervention and have shown good results [3, 4, 6]. Law et al.
is considered in patients with pre-existing implanted the entire GDD before the KPro proce-
glaucoma. dure, in the same sitting. The tubes were mainly
14  Combined Surgeries: Glaucoma Drainage Devices with Boston KPro 95

inserted into the anterior chamber or the ciliary extending 4–6 clock hours, and the limbus-based
sulcus. Their results showed good outcome with flap is made by incising the conjunctiva and
less complication rate. In 82.8% of patients, KPro Tenon’s capsule at least 8  mm posterior to the
was well retained, and complications like corneal limbus. Relaxing incisions of 5 mm are given on
necrosis, retinal detachment, endophthalmitis, both sides of the flap. The plate is positioned
and vitritis were less seen. 8–10  mm away from the limbus in the supero-
temporal quadrant, whereas for superonasal
quadrant implantation, the plate is positioned
14.3.2 Surgical Steps and Tips 8  mm away, to avoid compression on the optic
for Surgery nerve (Fig.  14.2). The valve of the implant is
primed by injecting balanced salt solution
Surgery can be performed under peribulbar or through the drainage tube using a 30-gauge can-
general anesthesia. The entire GDD can be nula to ensure that the valve is open prior to its
implanted after placing the KPro or vice versa insertion. Care should be taken to avoid touching
(Fig.  14.1). Alternatively, the plate of the GDD the valve site with forceps as this may damage
can be fixed first followed by KPro implantation, the function of the valve. The plate is secured to
and then the tube can be inserted by visualization the sclera with 9-0 nylon. The cornea surgeon
through the KPro optics. Any quadrant can be then implants the B KP I. The tube of the GDD is
chosen for implantation, superotemporal quad- laid on the surface of the cornea by stretching it
rant being the most common, followed by supero- out and is shortened to the desired length with its
nasal, inferotemporal, and inferonasal. Superior sharp bevel facing up to allow 2–3 mm of tube in
rectus bridle suture or corneal traction suture or the anterior chamber. Preferably the tube should
both can be applied for better exposure of the sur- be kept a little longer than the desired length as
gical site. Peritomy is done which could be either there are chances of postoperative tube retrac-
limbus based or fornix based, according to the tion. To prevent movement of the tube, a radial
surgeon’s preference. A fornix-based conjuncti- groove is made in the sclera, 0.75 mm behind the
val flap and Tenon’s capsule are dissected to limbus, and the edges of the groove retracted
allow insertion of the plate of the implant into using mild cautery. A track in the sclera is created
sub-Tenon’s space 8–10 mm behind the corneal through this groove with a 23G bent needle. The
limbus. needle should remain parallel to the plane of the
The fornix-based flap is made by incising the iris, and viscoelastic material injected into the
conjunctiva and Tenon’s capsule at the limbus, eye through this track.

Fig. 14.2  Insertion of plate of AGV, 8–10 mm away from


Fig. 14.1  Placement of Boston Kpro type I the limbus
96 S. Dubey et al.

Fig. 14.3  Placement of scleral patch graft over the tube

In cases where the anterior chamber view is Fig. 14.4  Conjunctival suturing with 8-0 polyglactin
obscured due to corneal scarring, the tube is suture
inserted blindly along an imaginary plane
directed parallel to the plane of the iris 0.75 mm
posterior to the limbus for anterior chamber tube
placement. For sulcus placement of tube, entry
into the eye is made 1.5–2  mm posterior to the
limbus, and for placement of the tube through the
pars plana route, entry is made 3.5 mm posterior
to the limbus with concomitant vitrectomy. The
tube is fixed to the sclera with 9-0 nylon suture.
The anterior part of the tube is covered with a
donor scleral patch graft/cornea/processed peri-
cardium which is fixed to the sclera with 9-0
black nylon sutures (Fig. 14.3). It is always better
to use a partial-thickness corneal or scleral patch
graft instead of the full-thickness graft as it is less
bulky, and thus, there are less chances of limbal Fig. 14.5  Placement of BCL over the B-KP I at the end
of the surgery
conjunctival retraction postoperatively. In cases
of nonavailability of donor tissue, tube can be
placed beneath a scleral tunnel to prevent tube
extrusion. The conjunctival flap is closed with
8-0 or 10-0 polyglactin suture (Fig. 14.4). A ban-
dage contact lens (BCL) is then placed in the eye
(Fig. 14.5).

14.3.3 Pars Plana Tube Insertion

Pars plana insertion of the tube is done by per-


forming a three-port vitrectomy after fixation of
the plate of the GDD and implantation of KPro
(Fig. 14.6). Sclerotomies are made in inferotem-
Fig. 14.6  Vitrectomy ports made after fixation of the
poral, superotemporal, and superonasal quad-
plate of AGV to the sclera
14  Combined Surgeries: Glaucoma Drainage Devices with Boston KPro 97

pars plana vitrectomy is now the chosen tech-


nique. This technique is ideal in these cases as the
conjunctiva is usually scarred and the fornices
are shallow.

14.3.4 Complications Following GDD

1. Blocked tubes: Corneal diseases such as SJS


syndrome, OCP, and chemical burns may lead
to failure of GDD due to formation of a thick
capsule around the shunt plate restricting flow
of aqueous [19, 20]. Few studies have shown
that by modifying the plates and/or changing
Fig. 14.7  Insertion of tube through one of the vitrectomy the drainage locations of GDD, resistance to
ports after completion of vitrectomy
flow of aqueous can be reduced. The drainage
locations could be the various cavities around
rants, respectively. The distance from the limbus the eye such as ethmoid and maxillary sinus,
is usually 3–4 mm. In cases of extensive anterior lacrimal sac, and lower lid fornix [21–23].
segment pathology where the limbus is not The aqueous can be drained to these locations
clearly defined, the measurements are made from by the help of extension tubes.
the center of the cornea. Wide-angle viewing sys- 2. Tube erosion: Tube may get eroded through
tem is used for visualization. A complete vitrec- the patch graft and the conjunctiva as well.
tomy is performed with or without the aid of There are many risk factors that may lead to
triamcinolone acetate. Triamcinolone acetate erosion of the tube. One of the major risk fac-
helps in visualizing and removal of vitreous tors is duration of the GDD in situ. The longer
fibrils which may cause plugging of tube of GDD the GDD in the eye, the greater is the risk of
[18]. At the end of vitrectomy, one of the superior erosion [24]. Presence of bandage contact lens
sclerotomies, usually temporal, is used for inser- (BCL) in these eyes is another risk factor [25].
tion of tube of the implant in pars plana region BCL rubs against the conjunctiva over the
(Fig.  14.7). The tube is fixed to the sclera tube resulting in tube exposure [24]. This may
­following which the infusion cannula is removed. further lead to complications like endophthal-
This decreases the chances of hypotony. mitis, hypotony, choroidal detachment, and
Vitrectomy at the time of keratoprosthesis and extrusion of the device. To avoid such compli-
GDD implantation has many advantages: cations, prompt surgical revision is advised.
Huddleston et al. reviewed eyes with tube ero-
–– It gives an overall view of the fundus and thus sion repair and found that 45% of the patients
gives an idea about the patient’s visual could be managed by an additional surgical
potential. repair, whereas 15% required GDD removal
–– It helps in clearing potentially inflammatory [26]. Preoperatively, the status of the conjunc-
material which may lead to retro-prosthetic tiva should be well examined. If the conjunc-
membrane [6]. tiva adjacent to the erosion is healthy,
–– It prevents vitreous incarceration of the tube [4]. sufficient and loose enough to cover the ero-
–– Vitreous biopsy sample can be procured. sion, then the erosion is repaired with a new
graft over the tube followed by closure with
Traditionally, vitrectomy was done through the adjacent conjunctiva. The following tis-
open-sky technique; however, with the advent of sues can be used as graft tissues in repair of
micro-incisional techniques, 23- or 25-gauge tube erosion. They are the autologous and
98 S. Dubey et al.

donor eye tissues (split-thickness hinged References


scleral flap [27], cornea, conjunctival pedicle
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3. Chew HF, Ayres BD, Hammersmith KM, et  al.
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Glaucoma Drainage Devices
in Children 15
Oscar Daniel Albis-Donado
and Alejandra Hernandez-Oteyza

15.1 Introduction surgical procedures for an adequate IOP control,


and GDD are frequently used in the second or
Childhood glaucomas represent a diagnostic and third surgical attempt [3].
therapeutic challenge for both ophthalmologists The Molteno Glaucoma implant (MGI) (IOP
and glaucoma specialists, not only because Inc., Costa Mesa, CA, USA) was the first GDD
achieving intraocular pressure (IOP) control is used in children in 1973, followed by the
difficult but also because some patients may still Baerveldt glaucoma implant (BGI) (Pharmacia
have poor vision in spite of successful IOP con- and Upjohn Inc., Kalamazoo, MI, USA) and the
trol due to amblyopia, corneal opacities, and/or Ahmed glaucoma valve (AGV) (New World
uncorrected high myopia and astigmatism. Medical, Inc., Rancho Cucamonga, CA, USA),
Medical treatment is only used adjunctively to the latest, being currently the most used GDD in
reduce intraocular pressure (IOP), but the main- children [4].
stay of treatment is surgical management [1, 2].
All cases of primary congenital glaucoma require
surgical treatment, and although angular surgery 15.2 Ahmed Glaucoma Valve
(goniotomy or trabeculotomy) has been the pre-
ferred first procedure, glaucoma drainage devises The AGV was approved by the US Food and
(GDD) have a leading role in refractory cases and Drug Administration for glaucoma surgery in
are even preferred as a first surgical effort in 1993. It is a tube-shunt device with unidirectional
selected cases where other surgeries are contrain- flow and a restrictive mechanism that has the
dicated or unlikely to succeed (i.e., when there is advantage of decreasing early postoperative
significant conjunctival scarring) [3–10]. hypotony, by opening only when the pressure
Furthermore it has been found that 20% of chil- surpasses 8  mmHg. Retrospective studies on
dren with glaucoma often require two or more AGV in children reveal a 28–49% in IOP reduc-
tion [4, 6–13].
O. D. Albis-Donado (*)
Instituto Mexicano de Oftalmología,
Querétaro, Mexico 15.2.1 Ahmed Valve Models
A. Hernandez-Oteyza
Asociación Para Evitar la Ceguera en México, Four Ahmed glaucoma valve models have been
Mexico City, Mexico
used in children: the non-flexible polypropylene
Omesvi Ophthalmic Diagnostics, S-2 and S-3 and the flexible silicon FP7 and FP8.
Mexico City, Mexico

© Springer Nature Singapore Pte Ltd. 2019 101


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_15
102 O. D. Albis-Donado and A. Hernandez-Oteyza

The S-3 model was originally designed for sufficiently avoid hypotony for most children due
children under 12 years of age. It has a smaller to their activities [30–32].
single plate than the S-2 model (width, 9.6 mm
vs. 13.0 mm; length, 10.0 mm vs. 16.0 mm; sur-
face area, 96.0 mm2 vs. 184.0 mm2), but the tube 15.4 Baerveldt Glaucoma Implant
dimensions remain the same. The FP7 and FP8
models are the equivalent to de S-2 and S-3 mod- The Baerveldt glaucoma implant (BGI) was
els in size, respectively, but the single plate is developed as an alternative, larger surface-area
made of silicon instead of polypropylene, which implant with a softer, radio-opaque material. The
in theory reduces the formation of fibrous tissue, principle of this non-valved device is similar to
hence encapsulation, allowing a higher success the MGI, but it incorporates four fenestrations on
rate, although there is contradictory evidence in its body, designed to let fibrous tissue grow
this matter [14–29]. through them and limit bleb size and secondary
Currently, ultrasonic biometry of the eye size is strabismus.
essential in deciding the implant’s model; the S-3 As with all glaucoma devices, it is designed to
and the FP8 models should be used when the have the tube inserted into the anterior chamber,
eye’s axial length is smaller than 20.5 mm, inde- but it is possible to insert the tube behind the iris
pendently from the patient’s age. Sometimes or through pars plana, a version with a Hoffman
though, in newborns with very large globes but elbow is available for this purpose. The available
with normal size orbits, there may not be enough sizes are 250 and 350 mm2, and there seems to be
space to fit in an adult size implant, so an S-3 or no significant difference in terms of IOP control
FP8 model must be placed to attempt an initial in the long term, so individual criteria for each
IOP control; in these cases, valve replacement at eye should be used to choose the best model
a later age is sometimes necessary to obtain long-­ [30, 32–36].
term IOP control.

15.5 Surgical Techniques


15.3 M
 olteno Glaucoma Drainage for Valved and Non-valved
Device Devices

The Molteno glaucoma drainage device (MGI) There are many variations in the surgical tech-
was the first glaucoma device to offer drainage to nique to implant a glaucoma device, many which
a posterior bleb, away from the limbus, although require the opening of a scleral flap and a patch of
the first surgeries did have the implant at the lim- various materials to cover the tube. We prefer the
bus. With more than 30 years of mostly positive scleral tunnel technique described by Dr. Felix
experience and extensive long-term research, the Gil-Carrasco, as it has proven to decrease signifi-
newest Molteno 3 offers improved surgical time, cantly the risk of tube extrusion and requires no
a better material, a lower profile, and possibly additional tissue to be used as a patch [1, 17, 21].
better results regarding IOP control. Small children have to be operated under gen-
The use of MGI in pediatric glaucomas has eral anesthesia. An examination under anesthesia
very good reported rates of success but still is made before starting the surgery, in which IOP
necessitates close follow-up in order to detect must be measured during induction. Special
any possible complication. Early hypotony is attention must be put on the conjunctiva and the
very common during the first 6  months of sur- angle to better plan the implantation of the valve
gery, so the use of a tube ligature is mandatory; and the tube. Some older children in whom gen-
we believe this is a sound recommendation for eral anesthesia is contraindicated may be oper-
children, because the pressure ridge might not ated under sedation and topical anesthesia.
15  Glaucoma Drainage Devices in Children 103

Before beginning, we strongly suggest remov- secured using absorbable sutures, and then the
ing all talcum powder from the surgical gloves conjunctiva should perfectly cover the patch
with a wet gauze. The valve’s tube must be and be fixed water-tightly to the limbus [4–8,
primed with balanced salt solution or viscoelastic 10–16, 37, 38].
material; this is particularly important for the The technique just described does not vary
AGV or it might not work at all. much from that used in adult patients, with the
Additional topical anesthesia and sub-Tenon exemption that absorbable sutures are used to
lidocaine help reduce the risk of vagal reflexes close the conjunctiva in children. So, what is
from any manipulation of the extraocular mus- “special” about inserting a valve in a child’s eye?
cles. A fornix-based conjunctival flap is per- Well, children with primary congenital glaucoma
formed in the superior temporal quadrant of the tend to have large corneas and thin scleras, and
eye (if it is the second valve implanted, the supe- limbal structures may be distorted beyond recog-
rior nasal quadrant is used), followed by careful nition. If the globes are larger but the orbits
dissection of Tenon’s capsule to create a pocket aren’t, the space between these two structures
and adequate cautery of episcleral vessels, when might be smaller, making it more challenging to
needed. The valve’s plate is then inserted under implant the valve.
the conjunctiva/Tenon flap and firmly secured to Extraocular muscles may be thin and elon-
the sclera using 7-0 silk suture; 8 mm posterior to gated and may not stretch properly, making it dif-
the limbus if an MGI, BGI, or an S2 AGV model ficult to rotate the eye inferiorly to be able to
is used; and at 9 mm from the limbus when using work in the superior temporal quadrant; traction
the FP7 model (if the valve is placed in the supe- sutures may be used to aid us with this problem,
rior nasal quadrant, sometimes it must be fixed 1 but they will induce folding of the flexible sclera,
or 2 mm nearer to the limbus). making the construction of the tunnel and the
A scleral tunnel is then performed using a 23G insertion of the tube very difficult.
needle folded in a “Z” shape, starting at 4  mm As mentioned before, the sclera is thinner,
posterior to the limbus and rectifying its direction making the suture of the valve’s plate a risky
abruptly at the limbus to enter the anterior cham- step; furthermore, sometimes, the plate must be
ber parallel to the iris plane: The needle must be placed more posteriorly than the usual 8–9 mm
mounted on a viscoelastic syringe to be able to because the apparent position of the limbus is
reform the anterior chamber; as we remove the usually more anterior than its real position (where
needle from the eye, viscoelastic material must we’d find the angle structures); if this is the case,
be injected into the tunnel. The silicon tube is the plate must be fixed to the sclera 10–11 mm
then trimmed to create a 30–45° bevel which posterior to the apparent position of the limbus.
must be facing up; the tube is then inserted into For the same reason, the scleral tunnel must also
the scleral tunnel. The conjunctiva/Tenon is then be 1 or 2 mm longer, initiating it 6 mm from the
closed at the limbus with 8-0 polyglactin (Vicryl; apparent position of the limbus; the abrupt change
Ethicon Ltd) inverted sutures. in the direction of the limbus must also be done a
The tube must be ligated when using either an bit posteriorly, to ensure the tube enters the ante-
MGI or BGI, using an absorbable 7-0 or 8-0 rior chamber through the trabecular meshwork.
Vicryl suture. If there is need for early filtration in Secondary glaucomas in children present in
cases of advanced glaucomas, an AGV might be an eye that had had a normal development, so the
the better alternative, but a venting slit in the tube globe’s size and scleral thickness is usually simi-
anterior to the ligature can provide some filtration lar to that of an adult. Sometimes secondary glau-
for the first 3–4 weeks until the suture is released. comas have abnormal angles and corneal
If a graft patch is to be placed, the tunnel opacities, making surgeries more challenging.
might not need to be so long, so insertion of the When operating on eyes with pseudophakia or
tube becomes easier, but the patch must be aphakia, one must be prepared to perform an
104 O. D. Albis-Donado and A. Hernandez-Oteyza

anterior vitrectomy, when necessary, to remove an AGV or a 250 BGI or a Molteno 3 is possible
any remaining vitreous from the anterior cham- in the inferior temporal or nasal quadrants, but
ber and prevent it from blocking the tube [39]. It because this is rarely performed, there is no avail-
is not uncommon to have to remove inflamma- able data as to its success rate [18].
tory membranes, anterior or posterior synechiae, Vision tends to improve or remain stable in
so it is always wise to have extra viscoelastic most children after implanting an AGV and
material, anterior vitrector, retinal forceps, and seems to be a bit more blurry with non-valved
microincision scissors on hand. implants. This may be due to the period of ele-
Postoperative care includes 1% prednisolone vated IOP before the ligature gets loose. Most
acetate every 2 h during the daytime in the first patients with one or two GDD will need one or
week and tapered weekly over 1 month. Antibiotic more glaucoma medications at some point after
drops must be installed four times a day until the surgery to maintain an adequate IOP control, but
absorbable sutures fall off (2–4 weeks). the number of needed medications seems to be
When using one of the non-valved implants, lower with BGI.  Some may even require addi-
the IOP might be very elevated until the ligature tional, more aggressive glaucoma surgeries, such
is released, so aqueous suppressants might be as cyclodestructive procedures.
needed to maintain an IOP below 30, or even bet- Having more than two previous glaucoma sur-
ter below 20, for the 3–5  weeks needed for the geries and intraoperative complications are rec-
ligature to loosen. ognized predictors for failure. This reflects on the
importance of having as much experience as pos-
sible in GDD implantation in adult eyes before
15.6 S
 uccess Rate of the Three daring to operate on children, and on choosing
Implants the right time to perform the implant, even con-
sidering primary insertion on selected cases.
Success rate reported in the literature is some- Hispanic ethnicity and female sex have been sug-
times difficult to compare because often different gested to be risk factors for failure, but the under-
definitions of success are used, plus “glaucoma in lying reason is yet unknown.
children” encompasses various entities with dif- All studies show that success rates for GDD
ferent pathophysiologies and risk factors that can decline over time; the pediatric population needs
influence a surgery’s success. Most studies con- a longer valve survival, so efforts to find medica-
sider success when postoperative IOP lies between tions or surgical procedures that prolong such
6 and 21  mmHg, without complications that survival are essential.
require further surgeries or the loss of light per-
ception. Furthermore, up to 45% of the children in
whom valves are implanted have undergone pre- 15.7 Complications
vious glaucoma surgeries before the AGV implan-
tation, thus modifying its success potential. Trans-surgical complications from AGV are sim-
Having said that, cumulative probabilities of ilar to those found in adults and include hyphema
success reported in literature are around 63–97%, and lens touch with subsequent cataract forma-
45–86%, 51–87%, 41–45%, and 33–56% at 1, 2, tion. However, there are two tube-related postsur-
3, 4, and 5 years, respectively. The mean time to gical complications that are quite unique to the
failure in refractory pediatric glaucoma reported pediatric population: retraction of the tube into
in different studies is 19–29 months. the scleral tunnel due to the globes’ growth, espe-
After a second implantation, more commonly cially in unsuccessful cases where high IOP con-
reported with AGV, IOP lowers further; the tinues to cause buphthalmos and, on the other
cumulative probability of success reported in the hand, plate migration secondary to the shrinkage
literature is 86–93% in 1 year, 86–89% in 2 years, of the sclera and globe after IOP reduction, with
and 53–69% in 5 years. A third implantation of the tube advancing into the anterior chamber,
15  Glaucoma Drainage Devices in Children 105

often closer to the corneal endothelium. Silicon-­ extreme in the pediatric population, especially in
plate FP7 AGV has posterior holes through which patients with previous surgical interventions on
fibrous tissue can grow, fixating the valve further the conjunctiva; for this reason, attempts to regu-
and making migration less likely, although it can late and control the healing process of blebs are
still happen due to eye growth. constantly being made. The possible benefit of
Other postoperative complications are similar using silicone plates instead of polypropylene
in children and in adults, but incidences may plates has been mentioned previously in this
vary. Some complications require additional sur- chapter.
geries to correct them, which in children repre- Mitomycin C is an antimetabolite that inhibits
sents another challenge as it implies another fibroblast proliferation and collagen synthesis. It
round of general anesthesia. Postoperative com- is widely used intraoperatively or postoperatively
plications include tube block with iris or vitreous, in glaucoma-filtering surgeries in adults. There
hypotony, shallow anterior chamber, hyperten- are controversial results on the use of mitomycin
sive phase, tube malposition with tube-corneal C associated to GDD in children; some studies
touch, decreased endothelial cell density, cosmet- have found an increased success rate, while oth-
ically large blebs, bleb encapsulation, strabismus, ers show a decreased survival rate. Furthermore,
tube or valve’s plate extrusion, and endophthal- its use in children is much more restricted as dev-
mitis. Choroidal detachments are very rare in astating complications such as late-onset bleb-­
children and tend to disappear very quickly related endophthalmitis or tube erosion occur
[21, 22, 25, 33]. more frequently than in the adult population due
Corneal decompensation is more common in to the lower scleral rigidity in children [28].
children, and it’s secondary to tube-corneal Bevacizumab (Avastin, Genentech Inc., San
touch; it is related to the higher flexibility of tis- Francisco, CA, USA) is a recombinant antibody
sues and the continuous remodeling that occurs that binds to all isoforms of vascular endothelial
as the child grows. Loss of resistance around the growth factor (VEGF) and has been used as an
tube’s entrance to the anterior chamber explains off-label drug in ophthalmology to treat many
the anterior displacement of the tube’s tip fre- retinal pathologies (proliferative diabetic retinop-
quently observed in children. The greater inci- athy, neovascular age-related macular degenera-
dence of dyscoria observed in children might be tion, macular edema), and recently it has gained
due to the enlargement of the entrance of the tun- some turf as an adjunctive therapeutic agent in
nel into the anterior chamber [5]. glaucoma surgeries. Bevacizumab may be
Extrusion is a common long-term complica- injected at the end of the surgery at a dose of
tion observed in tubes implanted using patches, 2.5 mg between the conjunctiva and Tenon’s cap-
with an incidence of 5.6% in children to 2.5% in sule, next to or on top of the valve’s plate. A sec-
adults. The scleral tunnel technique reduces ond dose 1 week later, which is recommended in
extrusion risk to around 0.4–1.5% [21, 24]. adults, is not advised in children, since it would
require another round of general anesthesia [23].
Antiangiogenic agents like Bevacizumab and
15.8 Adjunctive Therapy antimetabolites such as mitomycin C have been
used intraoperatively in children as an attempt to
Glaucoma-filtering surgeries and tube-shunt pro- enhance valve survival, with a reported success
cedures fail due to excessive fibrosis, either by rate of 80–90% for mitomycin C and 80% for
creating a large encapsulated bleb that inhibits subconjunctival bevacizumab but with a safer
fluid exchange or, specifically in GDD, by fibro- profile for the second one. Further research is
vascular ingrowth into the valve’s chamber that needed to find a plate material or an adjunctive
virtually shuts it down, leading to failure of the safe therapeutic agent that prevents bleb encapsu-
procedure in both cases. The fibrous tissue lation and fibrovascular ingrowth, thus ensuring a
response following a GDD implant is more better success rate for GDD [29].
106 O. D. Albis-Donado and A. Hernandez-Oteyza

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9. Helmy H.  Combined trabeculotomy-­trabeculectomy
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10. Ou Y, Yu F, Law SK, Coleman AL, Caprioli

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MH.  Results of Ahmed glaucoma valve implanta-
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27.
Thieme H, Choritz L, Hofmann-Rummelt C,
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2014;18(6):550–3.
Modifications of Surgical
Techniques in Glaucoma Drainage 16
Devices

Kleyton Barella and Vital Paulino Costa

16.1 Introduction Molteno® implant (Molteno Ophthalmic Ltd.,


Dunedin, New Zealand), developed by Anthony
Glaucoma drainage devices (GDDs) are used to Molteno and launched in 1973. The Molteno®
redirect the aqueous humor to a subconjunctival/ implant has been used worldwide with good effi-
subtenon extraocular reservoir in order to reduce cacy, but hypotony in the immediate postopera-
the intraocular pressure (IOP). GDDs are fre- tive period was frequent due to the absence of
quently implanted in eyes with a previous trab- resistance to flow [3]. In 1976, the Krupin®
eculectomy, uveitis, and presence of upper implant (Hood Laboratories, Pembroke, MA,
perilimbic conjunctival scar or neovascular glau- USA) was developed, with a one-way valve,
coma. A GDD consists of a tube that connects the decreasing the postoperative risk of hypotony
intraocular space directly to the subtenon space [4]. In 1992, Lloyd, Baerveldt, Fellenbaum,
or to a valved or non-valved plate. These plates et  al. launched the Baerveldt® implant (BGI)
are available in various materials, sizes, and (Abbott Medical Optics, Abbott Park, IL, USA),
designs and are sutured to the sclera between the a non-­valved implant with a wing shape that is
rectus muscles [1]. positioned under the rectus muscles and sutured
The first attempt at GDD surgery, in which a to the sclera [5]. In 1993, Abdul Mateen Ahmed
horsehair was implanted into the anterior cham- launched the Ahmed® glaucoma valve implant
ber, was performed by Rollet and Moreau in (AGV) (New World Medical, Rancho
1906 [2], and the first “modern” GDD was the Cucamonga, CA, USA), which also included a
valve system. AGV implants are characterized
by a silicone tube connected to a Venturi-type
valve formed by two thin silicone elastomer
Electronic Supplementary Material  The online version membranes. Theoretically, these valves are
of this chapter (https://doi.org/10.1007/978-981-13-5773- designed to open with an IOP of 10–12 mmHg
2_16) contains supplementary material, which is available and to close with an IOP of 8–9 mmHg, with an
to authorized users. average flow of 2.75  μL/min, thus preventing
K. Barella postoperative hypotony [6]. Currently, the most
Penido Burnier Institute, Campinas, Brazil implanted worldwide GDDs are the BGI and the
Glaucoma Service, University of Campinas, AGV.
Campinas, Brazil The purpose of this chapter is to describe
V. P. Costa (*) modifications of surgical techniques and new
Glaucoma Service, University of Campinas, GDDs.
Campinas, Brazil

© Springer Nature Singapore Pte Ltd. 2019 109


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_16
110 K. Barella and V. P. Costa

16.2 Modifications of Surgical


Techniques

16.2.1 Scleral Tunnel

16.2.1.1 Gil-Carrasco’s Technique


The silicone tube that extends from the end of the
plate to the anterior chamber can lead to complica-
tions such as tube exposure, tube migration, and
endophthalmitis [7]. Usually, donor sclera or
Tutoplast® pericardium (Innovative Ophthalmic
Products, Inc., Costa Mesa, CA, USA) patches are
used to cover the tube in order to prevent such adverse
Fig. 16.1  A 23 G needle is connected to methylcellulose
effects. However, exposure to pathogens such as pri- 2% and is used to make a scleral tunnel 3 mm from the
ons from donor tissue may occur, which may put limbus. The needle enters the anterior chamber between
patients at risk for contracting Creutzfeldt-Jakob dis- the cornea and the iris. When the needle enters the eye,
ease [8]. Moreover, melting of the patch is frequent, methylcellulose is injected intracamerally to avoid
decompression and to decrease the risk of hypotony
which leads to tube exposure and requires new sur- (methylcellulose is not recommended in non-valved
gery. The real mechanisms behind this are unknown. devices). In cases of thin sclera or shallow anterior cham-
Some theories have been proposed, such as fast ber, we prefer to avoid this technique
immune-­ mediated melting (less than 180  days),
mechanical stress, and patch atrophy, all of them
leading to a progressive thinning of the graft [9].
Hence, passing the tube through a scleral tun-
nel could eliminate the risk of prion transmission
and reduce the risk of an autoimmune response.
Finally, eliminating the necessity of a graft may
decrease both cost and operative time, with better
cosmetic results.
Graft-free techniques have been invented for
GDDs since 1998 by Gil-Carrasco et  al., who
published the first variation of this technique by Fig. 16.2  Tube placed in the anterior chamber through
the scleral tunnel
creating a scleral tunnel into the anterior cham-
ber, 3  mm from the limbus in 14 patients with
uncontrolled uveitic glaucoma (Video 16.1) angulated, aiming for mid-anterior chamber, par-
(Figs. 16.1 and 16.2) [10]. allel to the iris plane and away from the posterior
corneal surface. The anterior chamber is entered
16.2.1.2 Gdih-Gdih Technique followed by injection of viscoelastic, which par-
In 2017, Gdih et al. evaluated the safety, efficacy, tially fills the scleral tunnel and the anterior cham-
and costs of AGV implantation through a 6 mm ber (valved implants). The tube is then passed
scleral tunnel. Eighty-four eyes underwent this through the scleral tunnel using the tube introducer
procedure with a success rate of 83% after and advanced until the tip reaches up to 2 mm into
24 months. The rates of scleral and conjunctival the anterior chamber (Fig. 16.3) [11].
erosion were 0% and 2.4%, respectively, with a
cost reduction of $192–376 per surgery.
In this technique, an scleral tunnel 6 mm from 16.2.2 Sherwood Slit in Non-valved
the superior temporal limbus was dissected using a Implants
crescent blade ending 1  mm from the limbus. A
23 G needle is then passed through the tunnel until Non-valved implants need a mechanism to pre-
it reached the end. At this point, the needle was vent postoperative hypotony. Intraluminal stents
16  Modifications of Surgical Techniques in Glaucoma Drainage Devices 111

Fig. 16.3  Schematic drawing of Gdih-Gdih scleral tunnel technique

5-0
Vicryl® ligature
Episcleral plate

Tube

Fig. 16.4  Schematic drawing of a BGI with the Sherwood slit anterior to the area of the Vicryl® occlusion

and occlusion sutures around the tube with Vicryl® intraocular pressure during the early postopera-
are frequently used to avoid hypotony after sur- tive period and hypertensive phase [12]. To make
gery. However, total occlusion of the tube is asso- the Sherwood slit, a 30° micropoint blade is
ciated with high IOPs in the early postoperative passed through the tube parallel to the scleral sur-
period. Sherwood described a slit in the tube ante- face (slit length of 0.6  mm), allowing aqueous
rior to the area of occlusion, allowing aqueous to drainage through the slits when the IOP reaches
escape to the subconjunctival space, lowering the 20–25 mmHg (Fig. 16.4).
112 K. Barella and V. P. Costa

16.3 N
 ew Glaucoma Drainage AGVs, Kim et  al. [16] analyzed the results of
Devices 154 AGVs. Success was defined as an IOP of
5–18  mmHg with at least 20% of reduction
16.3.1 Ahmed Glaucoma Valve M4® from baseline, with no loss of light perception
and no other glaucoma surgical procedure.
AGVs were initially manufactured with a poly- Patients who received the FP7 implant (n = 76)
propylene plate (“S” model). The plate material were followed for a mean follow-up of
was replaced by silicone, and its thickness was 578  ±  157  days and showed an IOP reduction
reduced while keeping all other features (flexible from 31 ± 10 to 13 ± 5 mmHg after 1 year. The
plates, “FP” model). Although the introduction of cumulative probability of success was 70% at
a silicone plate has increased the success rates of 1 year, decreasing to 61% at 18 months. Patients
this surgery, eyes frequently develop a hyperten- in the S2 group (n  =  38) were followed for a
sive phase 2–4  weeks following the procedure mean follow-up of 662 ± 186 days and showed
[13], which is explained by a decrease of the an IOP reduction from 33 ± 12 to 15 ± 8 mmHg
aqueous humor permeability through the fibrous after 1 year. The cumulative probability of suc-
capsule [14]. Recently, the M4 model was cess was 66% at 1  year, decreasing to 53% at
released, including the same valve, but covered 18  months. Finally, patients in the M4 group
with a polyethylene biocompatible porous shell (n = 40) were followed for a mean follow-up of
that theoretically decreases the risk of a hyperten- 504  ±  158  days and showed an IOP reduction
sive phase in the postoperative period, since it from 27 ± 12 to 15 ± 4 mmHg after 1 year. The
allows the fast vascularization of the polyethyl- cumulative probability of success was 80% at
ene plate (Table 16.1) [15]. 1 year, decreasing to 52% at 18 months. They
The M4 model has a 160  mm2 surface area found that the mean IOP reduction (P  =  0.31)
(24 mm2 less than the FP7 model), but this area and the cumulative probability of success
doesn’t include the surface area of the porous, (P  =  0.99) were not significantly different
which increases the real area of contact with the between the groups.
capsule (Fig.  16.5). However, the published lit- Gil-Carrasco et  al. [17] prospectively com-
erature on the M4 AGV does not suggest a better pared the efficacy and safety of the S2 and M4
efficacy of this device when compared to the pre- Ahmed implants in 42 eyes with neovascular
vious models [16–18]. glaucoma (21 eyes in each group). At 1 year the
In a retrospective study to compare the S2 group showed an IOP reduction from 42 ± 12
safety and efficacy of the M4, S2, and FP7 to 16 ± 9 mmHg, whereas the M4 group showed

Table 16.1 AGVs® and their features


Valve Plate
Type Model Thickness Width (mm) Length (mm) Surface area (mm2)
Single plate FP7 0.9 mm 13 16 184
Single plate S2 1.9 mm 13 16 184
Single plate M4 2.0 mm 14 10.5 160
Single plate (pediatric) FP8 Not Informed 9.6 10 96
Single plate (pediatric) S3 Not Informed 9.6 10 96
Valve Materials
Type Model Plate body Tube Valve Valve box
Single plate FP7 Silicone Silicone Silicone Polypropylene
Single plate S2 Polypropylene Silicone Silicone Polypropylene
Single plate M4 Polyethylene Silicone Silicone Polypropylene
Single plate (pediatric) FP8 Silicone Silicone Silicone Polypropylene
Single plate (pediatric) S3 Polypropylene Silicone Silicone Polypropylene
All tubes present length of 25 mm with internal diameter of 0.305 mm and external of 0.635 mm [15]
16  Modifications of Surgical Techniques in Glaucoma Drainage Devices 113

Fig. 16.5  Methylcellulose application over the entire Fig. 16.6  Tube inserter with the M4 AGV
implant plate facilitates the insertion. The M4 valve is
protected by a rigid polyethylene capsule
sions, bovine-derived and porcine-derived, where
versions are cross-linked to become stable and
a decrease from 43  ±  11 to 18  ±  9  mmHg permanent gelatin implants. Hydrolytic stability
(P > 0.05). shows no evidence of hydrolytic degradation.
In a retrospective study, Cvintal et  al. [18] The biocompatibility properties of gelatin are
evaluated 75 surgeries with M4 implants. Success well established and do not cause a foreign body
was defined as IOP between 6 and 20 mmHg and/ reaction.
or 20% reduction, with no reoperation or loss of Three 6.0-mm-long implants, with different
light perception. Mean baseline IOP was internal diameters for varying levels of IOP con-
31.2  mmHg and decreased to 20.4  mmHg at trol, were initially designed. The XEN-140 had
3  months, 19.3  mmHg at 6  months, and the largest lumen, with an inner diameter of
20.3 mmHg at 1 year (P < 0.01). The cumulative approximately 140  μm. The XEN-63 had an
probabilities of failure were 32% and 72% at intermediate lumen (approximately 63 μm), and
6 months and 1 year, respectively. the XEN45 had the smallest inner lumen (approx-
The surgical technique is similar to that used imately 45 μm). Other than the geometric changes
when the PF7 model is implanted. However, to the implant, the material, manufacturing pro-
since the surface is porous and adheres to the cesses, and implantation procedures of all XEN
Tenon’s capsule, we prefer to coat it with methyl- models are identical. The XEN45 implant, in par-
cellulose before placing it in the subtenon space. ticular, was designed to reduce or eliminate
Also, a tube inserter can be used to facilitate posi- hypotony by providing enough outflow r­ esistance.
tioning the implant in the desired quadrant The design works similar to a valve. The inner
(Fig. 16.6) (Video 16.1). diameters were designed considering the total
implant length, the viscosity of aqueous humor,
and typical aqueous production rates of the
16.3.2 XEN® human eye. The XEN45, which has an inner
diameter of approximately 45 μm, allows a flow
In 2016, the FDA approved the XEN® Glaucoma of 0.02 μL/s or 1.2 μL/min (at 5 mmHg pressure
Treatment System (AqueSys Inc., Aliso Viejo, gradient), thus providing approximately
CA, USA). The XEN® gel stent is a hydrophilic 6–8  mmHg flow resistance, which essentially
tube composed of a gelatin cross-linked with glu- eliminates hypotony [19].
taraldehyde. The material has been extensively The implant is hard when dry but is designed
used in a variety of medical applications. The to be soft and flexible when hydrated. After being
implant has been developed in two material ver- implanted in the eye, it becomes soft within
114 K. Barella and V. P. Costa

1–2 min. In its natural hydrated state, the implant Newtonian fluids principles prevented hypotony
is straight but adapts to the tissue shape. Implant without the use of valve systems.
flexibility is an important criterion to avoid migra- In 2016, Sheybani et al. [20] published a pro-
tion and potential erosion. The implant has a typi- spective study of 49 patients with open-angle
cal “S” curve going through the scleral channel. glaucoma who underwent the insertion of the
This is an expected outcome during implantation XEN 140 Gel Implant with mitomycin C. Patients
that further mitigates potential migration. had a baseline IOP of 23.1  ±  4.1  mmHg on an
The XEN gel stent is deployed using the hand- average of 3.0 ± 1.1 medications. At 12 months,
held inserter and standard ophthalmic microsur- 89% of patients achieved an IOP ≤18 mmHg and
gical instruments. An inferior-temporal corneal ≥20% reduction from baseline. Forty percent of
incision is made, and cohesive viscoelastic is patients were medication-free at 12 months.
inserted in the anterior chamber. The needle Perez-Torregrosa et al. evaluated phacoemulsi-
enters the eye targeting the superonasal quadrant fication combined with the XEN45 implant and
(a surgical goniscope lens may be used to avoid subconjunctival mitomycin C in 30 eyes with
iatrogenic trauma and bleeding). The implant cataract and open-angle glaucoma. The baseline
enters through the scleral spur and exits the sclera IOP was 21 ± 3 mmHg, which decreased 29.3% at
3  mm posterior to the limbus into the subcon- 1 year. The mean number of drugs at baseline was
junctival space (care must be taken not to perfo- 3.1 drugs which decreased 94.5% at 1  year.
rate the conjunctiva at this point) (Fig. 16.7) [20]. Complications occurred only in three eyes, among
Sheybani et  al. [21] described the fluidics of which two were excluded because the implanta-
XEN and compared the Ex-Press and 10 mm sili- tion was impossible (subconjunctival hemorrhage
cone BGI. The flow testing was performed with a and extrusion when trying to reposition the
pressure transducer at multiple flow rates and a implant). In a third case, the bleb was encapsu-
syringe pump. At a physiologic flow rate of 2.5 μL/ lated at 5  months after surgical procedure. The
min, the steady-state pressures were the following: authors concluded that phacoemulsification com-
7.5  mmHg in the XEN45 group, 0.09  mmHg in bined with the XEN45 implant can effectively
the Ex-Press group, and 0.01  mmHg in the reduce IOP and the number of drugs in mild and
Baerveldt tubing group. The author suggests that moderate open-angle glaucoma patients [22].

Fig. 16.7  Schematic drawing of the Xen® implantation


16  Modifications of Surgical Techniques in Glaucoma Drainage Devices 115

16.3.3 InnFocus® saturated in 0.4 mg/mL mitomycin C (MMC) are


placed in the subconjunctival space for 3 min fol-
Another device under investigation is the lowed by irrigation with sterile saline solution. A
InnFocus MicroShunt® (Santen Pharmaceutical point on the sclera was marked 3 mm posterior to
Co., Ltd., Osaka, Japan), a microtube that shunts the limbus with the inked marker/ruler. A radial,
aqueous humor from the anterior chamber to a shallow scleral pocket (approximately 1  mm
flap formed under the conjunctiva and Tenon’s wide × 1 mm in length) is dissected. A 25 G nee-
capsule. This product uses a biomaterial called dle is advanced through the apex of the scleral
polystyrene-block-isobutylene-block-styrene, pocket into the anterior chamber above the iris
which is an ultrastable biomaterial that causes plane. The course of the drainage tube approxi-
virtually no foreign body reaction, minimizing mately bisects the angle that was formed between
inflammation and capsule formation. This shunt the iris and cornea. The MicroShunt is maneu-
is implanted via an ab externo approach vs. the ab vered through the scleral pocket and needle tract
interno approach usually associated with MIGS; with a forceps and the fins of the device wedged
however, it does not require dissection of the snugly into the scleral pocket. The proximal end
sclera. A study of 23 patients with MicroShunt of the shunt extends 2–3  mm into the anterior
placement with or without cataract surgery chamber. Flow of aqueous humor is confirmed by
showed that more than 95% had sustained “quali- observing drop formation at the distal end of the
fied success” (defined as an IOP ≤14 mmHg and tube. The distal end of the device is tucked under
IOP reduction ≥20% from baseline) [23]. the subconjunctival space to lie flush with the
The surgical technique starts with a 6 mm con- sclera, and the flap is closed with multiple inter-
junctival incision at the corneoscleral junction in rupted 10-0 nylon sutures on a spatula needle
the supero-temporal quadrant to form a fornix-­ [23]. Currently, there are no published results on
based conjunctival flap. The flap is dissected pos- the efficacy and safety of the InnFocus device
teriorly with scissors. Three LASIK shields (Fig. 16.8).

Fig. 16.8 Cross-­ 0.350 mm


sectional eye diagram
8.5 mm 70 microm lumen
illustrating the
dimensions and
placement of the novel
nea
MicroShunt 4.5 mm Cor
Needle
InnFocus Fins Tract Anterior Chamber
MicroShunt

IRIS
eb
a

Bl
tiv
nc

Lens
nju
s
Co
on
Ten
116 K. Barella and V. P. Costa

16.4 Final Comments 11. Gdih G, Jiang K.  Graft-free Ahmed valve implanta-
tion through a 6 mm scleral tunnel. Can J Ophthalmol.
2017;52(1):85–91.
In the last decades, we have evidenced the evolu- 12. Sherwood MB, Smith MF.  Prevention of early
tion of the GDDs and the surgical techniques for hypotony associated with Molteno implants by a
such implants. However, we are still in search of new occluding stent technique. Ophthalmology.
1993;100(1):85–90.
the perfect GDD, associated with extremely high 13. Ishida K, Netland PA, Costa VP, Shiroma L, Khan
efficacy and an attractive safety profile. B, Ahmed II.  Comparison of polypropylene and
silicone Ahmed Glaucoma Valves. Ophthalmology.
2006;113(8):1320–6.
14. Nouri-Mahdavi K, Caprioli J. Evaluation of the hyper-
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2002;86(5):587–92. M, Gargallo-Benedicto A, Osorio-Alayo V, Barreiro-­
9. Smith MF, Doyle JW, Ticrney JW Jr. A compari- Rego A, et  al. Combined phacoemulsification and
son of glaucoma drainage implant tube coverage. J XEN45 surgery from a temporal approach and 2 inci-
Glaucoma. 2002;11(2):143–7. sions. Arch Soc Esp Oftalmol. 2016;91(9):415–21.
10.
Gil-Carrasco F, Salinas-VanOrman E, Recillas-­ 23. Batlle JF, Fantes F, Riss I, Pinchuk L, Alburquerque
Gispert C, Paczka JA, Gilbert ME, Arellanes-Garcia R, Kato YP, et  al. Three-year follow-up of a
L. Ahmed valve implant for uncontrolled uveitic glau- novel aqueous humor MicroShunt. J Glaucoma.
coma. Ocul Immunol Inflamm. 1998;6(1):27–37. 2016;25(2):e58–65.
Glaucoma Drainage Devices:
Complications and Their 17
Management

Bhumika Sharma, Monica Gandhi,
Suneeta Dubey, and Usha Yadava

The management of glaucoma has undergone a • Valve related:


paradigm shift. Glaucoma drainage devices –– Hypotony
(GDD) have become the mainstay of treatment –– IOP fluctuation-hypertensive phase
for the management of refractory and compli- • Structural complications:
cated glaucomas. The GDDs are associated with –– Outflow obstruction
a special group of complications. This could par- –– Conjunctival erosion
tially be attributable to the complex nature of the –– Implant exposure
cases selected. It can also be dependent on the –– Tube migration
design and material inadequacies inherent in the –– Diplopia
contemporary GDDs. The role in the manage- • Surgery related:
ment of glaucoma is based on the patient and dis- –– Corneal decompensation
ease profile; however, before deciding the –– Endophthalmitis
surgery, one must know the associated complica- –– Vision loss
tions and the management of the same to make it –– Surgical failure
more safe, reproducible and dependable to pre-
vent rather than add to the burden of the disease GDD are broadly categorized as valved
progression. (Ahmed, Krupin) and non-valved (Molteno,
The complications can be broadly grouped Baerveldt). The non-valved implants lower the
under: intraocular pressure to a greater extent in com-
parison with the valved implants at the expense
of complications, primarily due to hypotony.
Valved implants are pressure-sensitive unidirec-
tional flow restrictors to prevent over filtration
and subsequent hypotony. Ahmed implant has
B. Sharma (*) · U. Yadava
Guru Nanak Eye Center, Maulana Azad Medical valves which restricts the outflow of aqueous
College, New Delhi, India below the critical pressure of 8–12  mmHg
M. Gandhi (Krupin slit valve works between 9 and 11), thus
Anterior Segment and Glaucoma Services, decreasing the chances of postoperative hypot-
Department of Ophthalmology, Dr. Shroff’s Charity ony [1].
Eye Hospital, New Delhi, India The classic design of a drainage implant is a
S. Dubey draining tube connected to an end plate. This
Glaucoma Services, Department of Ophthalmology, plate has a dual role. The end plate holds the
Dr. Shroff’s Charity Eye Hospital, New Delhi, India

© Springer Nature Singapore Pte Ltd. 2019 117


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_17
118 B. Sharma et al.

d­ istal end of the tube, thus preventing its block- tors induce one common mechanism, scarring,
age. The size (single or dual) of the end plate which leads to implant failure.
influences the size and thickness of the surround-
ing fibrous capsule, thus determining the final
IOP. The tube shunts the aqueous from the ante- 17.1 Hypotony
rior chamber to the end plate (located in the sub-­
Tenon’s space, most commonly The hypotensive phase lasts for around 1–4 weeks
supero-temporally) into a fluid-filled bleb. It is and the causes are:
hypothesized that the aqueous flowing through
the eyes with raised IOP carries pro-­inflammatory (a) The use of non-valved devices
cytokines which induce the formation of fibrous (b) Leakage from the complex (scleral entry,

capsule around the end plate in 4–6 weeks, giving button holing of overlying conjunctiva)
significant resistance to the flow further, and is (c) Till the formation of capsular thickness to a
primarily responsible for the surgical failure. critical level so as to offer adequate resis-
Once aqueous diffuses through this capsule, it is tance to the outflow
absorbed by the periocular capillaries and lym- (d) Malfunctioning valved implant valve
phatics into the venous circulation. Thereby (e) Non-device-related complications—choroi-
increasing the size of the end plate increases the dal detachment, cyclitis and perforation dur-
surface area for diffusion and lowers the IOP fur- ing the anchoring of the device
ther. It has been observed that increasing the size (f) Aqueous hyposecretion—pharmacological
of the end plate only up to a certain point lowers or otherwise
the IOP but does not influence the overall success
rate (which further takes into account multiple The patient can present with a low IOP with
other factors). Ayyala et al. [2] support this con- either a formed anterior chamber or a shallow
clusion in her study comparing the double-plate chamber (Fig. 17.1); it is important to understand
Molteno and the single-plate Ahmed valve, where the cause of the same. It can be conservatively
the overall success rate at 3  years was 50% in managed with medications (topical steroids and
both the arms, even though the IOP was signifi- cycloplegics) unless there is a tube-corneal
cantly lower in the Molteno group at all times. (Fig. 17.2) or a lens-corneal touch, in which case
It is also important to consider the material of early intervention is needed as delay might lead
the end plate. Polypropylene end plates are more to corneal decompensation and development of
rigid and exhibit increased micro motion in the cataract in phakic clear lens (Fig.  17.3). Rather
postoperative period inducing more scarring in than giving a blanket treatment, specific cause
comparison with the more compatible silicon needs specific management.
material. These polymers have a high binding
affinity for plasma and interstitial proteins exac-
erbating the cellular adhesion and cytokine
release inducing chronic inflammation and sub-
sequent fibrosis. (Remember RAM—rigid end
plates in Ahmed and Molteno.) Keeping this in
mind, the material of Ahmed end plate has been
lately changed to silicone (Ahmed glaucoma
valve—flexible plate). Also, the ridge on the
Molteno implant prevents the fibrous growth over
it in contrast to smooth surfaced end plate in
Ahmed which attracts the white cells and colla-
gen to the surface leading to more chances of Fig. 17.1  Shallow anterior chamber post-AGV
dense scarring [3]. Thus, all these multiple fac- implantation
17  Glaucoma Drainage Devices: Complications and Their Management 119

with the proximal end of the tube in the con-


junctiva. The next stage establishes the con-
nection with the aqueous only when the
encapsulation has occurred.
5. Vertical and horizontal cuts are given into the
tube at the proximal end.
6. Literature also describes performing an

orphan trabeculectomy (trabeculectomy with-
out antimetabolites) with the aim of scarring
in the proximity.
Fig. 17.2  Tube-corneal touch after AGV implantation
For other causes, leakage anywhere in the
complex can be best detected with Siedel’s test or
a forced Siedel’s test. If the leak is at the level of
conjunctiva, repair with suturing is the answer.
The device should be primed and adequately
checked before implanting for any malfunction-
ing, as detection later can cause a lot of distress
for the surgeon as well as the patient. For non-­
kissing choroidal detachment, patient is kept
under observation with topical steroids in combi-
nation with cycloplegics and oral steroids where
Fig. 17.3  Corneal decompensation and cataract develop- needed. Kissing choroidals need drainage.
ment after AGV implantation Cyclitis is managed with a strong cycloplegic
with local steroids (topical/subconjunctival/sub
tenon’s injections). Perforations during suturing
For non-valved devices, there are certain warrant a thorough peripheral evaluation with
described surgical modifications which offer cer- adequate laser barrage if perforation had been
tain resistance for controlled outflow. They are as deep enough to cause a retinal break or cryo-
follows: application whichever is feasible. Aqueous sup-
pressants should be stopped so as to allow
1. Temporarily ligating the tube with an absorb- aqueous to flow in sufficient quantity to keep the
able suture (5-0 or 6-0 polyglactin sutures; apparatus functional.
Vicryl or Ethibond), with a view that the According to the literature, Molteno implant
suture provides adequate resistance till the with modification has the lowest incidence of
fibrous capsule of required thickness develops transient hypotony (12%) in comparison with
around the plate which is generally 3–4 weeks. 26% when used without modification; Ahmed
2.
RIPCORD technique: a non-absorbable valve reports 14%, Krupin valve 17% and
(nylon or 3-0 prolene) suture if left in the Baerveldt around 15%.
lumen of the tube only to be removed later, so
as to prevent unrestricted flow through the
tube or temporary tube obstruction with col- 17.2 E
 arly and Late Hypertensive
lagen plug. Phases
3. Combination of internal occlusion with 5-0
nylon and external ligature with polyglactin Hypotensive phase is followed by a phase of
suture. increased IOP, more commonly seen with
4. Two-staged procedure: in the first stage, only valved implants. It usually begins in 3–6 weeks
the end plate is fixed at its desired position (early hypertensive phase) and lasts for about
120 B. Sharma et al.

4–6  months, resolving primarily due to the A randomized clinical trial evaluated the ben-
remodelling of the bleb. In contrast, the late efits of early aqueous suppression in valved
hypertensive phase begins about around implants.
4–6 months after the surgery and is the result The patients were grouped into treatment and
of a thick encapsulation around the end plate. controls. Those with IOP > 10 mmHg, topical dor-
The patient presents with painful diminution of zolamide and timolol combination was started on
vision and heaviness in the eye. On local exam- twice-daily dosage, whereas in the control arm,
ination, there is a congested eye with a large, the anti-glaucoma medications were added only
tense and inflamed bleb with the IOP as high as on need basis to keep the IOP below 15 mmHg.
30–35 mmHg. Some authors arbitrarily defined The observations made were as follows:
hypertensive phase as IOP >21  mmHg during
the first 6 postoperative months. It is hypothe- • Significantly greater IOP reductions occurred
sized that this complication is more commonly during the 1-year follow-up period in the
seen with valved implants (40–80% in Ahmed treatment group though no significant differ-
valve in comparison with 20–30% in Baerveldt ence in the use of anti-glaucoma medication at
and double-­plate Molteno) due to early expo- the end of 1 year between the two groups.
sure of the conjunctiva and Tenon’s to the • The mean IOP in the early treatment group
aqueous with pro-inflammatory cytokines was 14.0 mmHg compared with 16.8 mmHg
inducing early fibrosis and scarring. The in the control group (P = 0.012).
smaller size of the end plate along with the bio-
material, shape and consistency might also Thus, the observations support the hypothesis
contribute to the aetiology. Treatment, primar- that early exposure of conjunctiva and Tenon’s to
ily, is the use of anti-glaucoma medications, the aqueous humour was responsible for early
specifically aqueous suppressants to reduce and thickened bleb encapsulation and the preven-
further cytokines draining into the bleb and tion of the same resulted in better and efficient
stop the vicious cycle, and digital massage. If long-term results.
medications fail to control the IOP, other
options are:
17.3 Bleb Fibrosis
(a) Subconjunctival injection of antimetabolites
(mitomycin C or 5-fluorouracil) in the fornix To understand this, it is important to know the his-
away from the bleb (the question here is why tology of bleb formation. The aqueous from
away from the bleb when the site of action is patients with elevated IOP induces fibro-­
bleb—the answer to this is the site of action proliferative changes in subconjunctival space,
is not the bleb but the bleb wall. If these anti- and those from normotensive the eyes stimulate
metabolites get to enter into the bleb, then connective tissue degeneration. These histological
through the reverse route, they might enter changes were studied with Molteno implants in
the eye causing intense inflammation and three groups. In the first group, placing the end
further complications which are more dread- plate in the subconjunctival space without aqueous
ful than raised IOP) [4, 5]. resulted in uniform, avascular moderately cellular
(b) Bleb needling done with a 30G needle.
connective tissue about 20–60  μm thick and
Again, the entry is made away from the bleb, remained the same till 4  weeks. In the second
but the target is to break the dense fibrotic group, Molteno implantation without modification
bands around the end plate. resulted in vasodilation, oedema and infiltration
(c) Suture lysis for non-valved implants. with polymorphonuclear leucocytes in the first
(d) Revision of surgery by placing another shunt. week, resolving subsequently over 4–6 weeks leav-
(e) Removal of the cyst wall and the use of amni- ing a thick capsule of 400 μm. In the third group,
otic membrane. Molteno with modification resulted in thinner
17  Glaucoma Drainage Devices: Complications and Their Management 121

(200 μm) capsule with relatively lesser inflamma-


tion as compared to second group. It concluded
that fibro-proliferative process was stimulated
when aqueous drained into the subconjunctival
space with degenerative process coming into
action after the first postoperative month when
aqueous displaced the normal interstitial tissue
fluid at an IOP which exceeded the intracapillary
pressure. This excessive fibrous reaction is the
most common cause of bleb failure more com-
monly seen in the first postoperative year. Also the Fig. 17.4  Tube blocked by vitreous strand and blood
rough handling of the end plate during the surgery
may damage the valves within it or the smooth sur-
face which further contributes to fibrous tissue Blood and fibrin in many cases tend to retract
growth and subsequent fibrosis. Bleb encapsula- with topical medications (steroids), but in case after
tion has been estimated to be between 40 and 80% adequate treatment, clots still persist; tissue plasmin-
with Ahmed glaucoma valve and 20–30% with ogen activator (3.5 μg in 0.1 ml) is delivered locally
Baerveldt and double-plate Molteno implant. either into the anterior chamber or directly into the
lumen of the tube. Re-bleed is a risk involved which
needs to be assessed before injecting. If iris tissue is
17.4 Outflow Obstruction the offending agent, then delicate iris strands can be
directly managed with frequency-doubled Nd:YAG
There can be an obstruction anywhere in the path laser, whereas for thicker iris tissue occluding the
traversed by the aqueous from the proximal tip to lumen, argon laser iridoplasty may be required. If all
pooling in the subconjunctival space. Thereby, these fail, surgical release of iris tissue needs to be
the different levels of obstruction are: done at the earliest as low-grade chronic inflamma-
tion set-up will complicate the situation further.
• Proximal end of the tube Clear corneal phacoemulsification is supposedly
• Within the tube anywhere till the point it gets safe in the eyes with drainage implants. Vitreous
connected to the end plate clogging the lumen of the tube in the anterior cham-
• Outflow from the end plate ber can be cut using the frequency-doubled Nd:YAG
laser, whereas if the vitreous is the factor when the
Since we know that the proximal end of the tube is in the posterior segment, a thorough periph-
tube can be at various positions like anterior eral vitrectomy is required. Pars plana clip or a
chamber, ciliary sulcus or posterior segment, the Hofmann elbow prevents the kinking of the tube
blockage can be caused by the blood, fibrin, iris more commonly seen with pars plana placement.
tissue, lens material, the vitreous or kinking of For fibrous or a fibrovascular tissue ingrowth into the
the tube (Fig.  17.4). To evaluate, a well-­ end plate, surgery with manual removal of the tissue
functioning bleb has controlled IOP with a con- is required to establish the flow.
vexity around the end plate formed by the bleb
wall, whereas in a non-functional bleb, the con-
junctiva is seen skinning the end plate where the 17.5 Conjunctival Erosion
structural details of the end plate can be made out and Device Exposure [6]
with raised IOP.  Echography can also be per-
formed to assess the flow when in doubt. Usually Any point from the limbus to posterior bleb can
the obstructions at the proximal tip can be have a conjunctival erosion either due to mechan-
detected on slit lamp evaluation, whereas at the ical exposure or immune-related melt, excessive
other sites, it might not be visible directly. tension, mechanical rubbing of tissue overlying
122 B. Sharma et al.

the tube, poor perfusion and ischemic damage to


the conjunctiva. Prolonged operative time,
increased instrumentation, desiccation of con-
junctival tissue and inflammatory changes in the
combined procedures add further to the risk.
Non-absorbable sutures used to fix the end plate
might also erode the conjunctiva, and a tract is
made for microbial entry. The conjunctival ero-
sion gives a path to the microbes to invade onto
the tube and then intraocular paving into endo-
phthalmitis. The overall incidence of tube expo-
sure is 2% with an average rate of exposure of Fig. 17.5  Tube exposure
0.09% per month. Byun and colleagues [7] have
reported nine times higher risk of exposure with
even a single surgery done before with Ahmed
GDD in comparison with virgin eyes. Also, it is
more commonly seen in inferior quadrant due to
narrow space and lesser conjunctiva to cover the
implant. So conjunctival erosion should be taken
with a pinch of salt and dealt as early as possible.
Besides a risk factor for infection, it also poses a
lot of foreign-body sensation and grittiness to the
patient causing discomfort despite good IOP con-
trol. Hence, to prevent the same, it is advisable to
use donor sclera, cornea, fascia lata, or amniotic Fig. 17.6  Tube exposure
membrane graft over the device and below the
conjunctiva and Tenon’s at the time of closure in
the primary surgery. Also, it is advisable to enter
the anterior chamber through a sclera tunnel
rather than direct entry. Though erosion is more
common over the anterior part of the device
because end plate rests under a thick Tenon’s
layer and fibrous capsule, poor anchorage of the
end plate can lead to erosions. Huddleston and
colleagues [8] postulated that black race, diabe-
tes, previous glaucoma laser procedures and
combined shunt implantation had worst outcome
after initial shunt exposure repair. The physical
properties of the suture material and the bulk of
the knot add further to the risk because compres- Fig. 17.7  Scleral patch graft and conjunctiva covering
sion of small vessels by the suture material cause the exposed tube
local ischemia and apoptosis leading to implant
exposure. If the tube exposure has occurred, good 17.6 Tube Migration
topical antibiotic cover with lubricants should be
used till the patient is taken up for surgery. In sur- The proximal end of the tube might change its
gical repair, patch grafts are used along with con- relative position in comparison with that as left on
junctival advancement or autograft. Recurrent the table. Tube advancement or retraction might
erosions warrant device explantation (Figs. 17.5, occur. The common causes are trauma or change
17.6 and 17.7). in the size of the globe as in paediatric age group,
17  Glaucoma Drainage Devices: Complications and Their Management 123

aphakic or vitrectomized eyes and loose anchor- It is transient and resolves spontaneously in
age of the end plate. The expected change should majority of the cases as the postoperative perioc-
be borne in mind, and the length of the tube with ular oedema resolves. It is best to wait and
position of the tip is accordingly decided. In pae- observe. In cases when it persists, the various
diatric device implantation, the length is left lon- modalities are:
ger with the tip at mid iris since the growth of the
globe causes tube retraction, but not too long to • Administration of aqueous suppressants in the
cause sensory deprivation amblyopia, lenticular early stages to limit the bleb height.
touch causing cataract or corneal touch leading to • Bleb massage and bleb needling once encap-
endothelial damage. So in both advancement and sulation is complete.
retraction, surgical repositioning with adjustment • Prism therapy in mild cases.
of the tube is required. In addition, in retraction, • At the end, if nothing works and diplopia is
tube can also be extended using 18G angiocathe- limiting the day-to-day activity, the device
ter or extensions available from certain manufac- needs to be removed and placed at a new loca-
turers of the device. tion or device modification.

17.7 Diplopia 17.8 Corneal Decompensation

Overall, the reported incidence is between 6 and The endothelial damage primarily in GDD is
18%. Diplopia is the result of persistent restric- through the tube-corneal touch or the insult on
tive strabismus due to the below mentioned rea- endothelium during the surgery. The eyes with
sons [9–11]: pre-existing corneal diseases or penetrating kera-
toplasty are more predisposed. Corneal decom-
• Mechanical resistance offered by the end plate pensation has been reported to be 30%, graft
as well as the bleb due to crowding failure in PKP eyes with GDD ranges of 10–51%.
• Change in the vector forces due to disturbance The degree and duration of raised IOP result in
in the muscular fibres by the insertion of the significant endothelial cell loss ranging from 10
lateral ends of the plate (Baerveldt end plate is to 33% following an acute attack of angle-closure
inserted under the muscle belly) glaucoma and around 77% in patients in acute
• Adhesions formed between the end plate, attack lasting more than 12  days. PKP induces
muscles, sclera and the bleb ocular hypertension in as high as 30% of the eyes
• Fat adherence syndrome and more so in those with pre-existing glaucoma,
primarily due to trabecular meshwork distortion.
This complication is more commonly seen in The rate of corneal decompensation secondary to
the following scenarios: Baerveldt placement in the Tube Versus
Trabeculectomy Study was 7% at 1 year and 16%
• Older, non-fenestrated Baerveldt implant at 5 years. In the Ahmed Baerveldt Comparison
(9%). Hence preferred are the newer, smaller Study, a corneal decompensation rate of 22% was
250  mm2 fenestrated Baerveldt devices. reported.
Fenestrations allow the growth of the fibrous Sidoti et al. elucidated the mechanism that the
bands through the plate reducing the profile of tube is in contact with the iris causing constant irri-
the bleb. In contrast, in Ahmed valve, the tation and chronic low-grade inflammation caus-
reported incidence is 3% and in Molteno with ing PAS and fibrosis and subsequently secondary
ligature is 2%. angle-closure glaucoma along with endothelial
• Baerveldt implant of 350 mm2. decompensation and immunological graft rejec-
• Superonasal positioning of the device. tion. The pars plana tube insertion is a reasonable
• Placement of the wings of the implant below option in patients who have undergone PK or in
the muscles. whom PK is anticipated, resulting in better rates of
124 B. Sharma et al.

corneal graft survival and IOP control comparable • Neovascular glaucoma—22–78% (poorest
with those achieved with limbal tube insertion. surgical outcome)
Complications related to anterior chamber tube • Uveitic glaucoma—75–100%
placement are avoided. Thus, placing the proximal • Developmental glaucoma—44–100%
end into the ciliary sulcus or posterior segment is • Cataract surgery—50–88%
the preferred modality in patients with already • Re-surgery in failed previous implant
compromised corneas or PKP but with its own surgery—44–88%
risks involved of retinal detachment (6%), vitreous
obstruction of the tube tip (9%), epiretinal mem- Overall, the failure rate is reported to be about
brane (9%) and cystoid macular oedema (3%). 10–15% per year over the first 3–4  years. Five-­
year results from the Ahmed Baerveldt compari-
son study demonstrate a failure rate of about
17.9 Endophthalmitis 40–45% (44.7% for Ahmed versus 39.4 for
Baerveldt, P = 0.65). High IOP was the major fac-
Overall, the rate reported with GDD is quite low tor 80% for Ahmed valve failures and 20% contri-
(around 2%). As explained already, conjunctival bution from other causes like persistent hypotony,
erosion due to multiple reasons and implant implant exposure and vision loss. In contrast, for
exposure creates a path for microbial entry. The Baerveldt failures, 53% were due to high IOP and
patient presents with pain and conjunctival con- around 47% due to other causes. On detailed
gestion along with diminution of vision and an review, it has been observed that fibrotic scar is
inflamed bleb. Exudation in the anterior chamber the major culprit for the failure of implant surgery.
around the tube can be seen on slit lamp evalua- Various modifications are done to reduce scarring
tion and subsequent posterior segment evaluation with the use of topical anti-­inflammatory agents
if media clarity is adequate, else with like steroids for a longer time, use of more bio-
ultrasonography. compatible flexible material for the end plates and
use of antimetabolites as used in trabeculectomy.
But the results of antimetabolites is not very con-
17.10 Vision Loss vincing. Cantor et  al. [12] published their work
where they randomized 25 consecutive patients to
The various causes of vision loss are: receive MMC or balance saline solution during
Molteno implantation but found no significant
• Corneal decompensation IOP difference between the two groups. Similarly,
• Progression of glaucoma and snuff-out Costa et  al.’s [13] study on patients with refrac-
phenomenon tory glaucoma could not prove any additional
• Suprachoroidal haemorrhage benefit of using antimetabolites. There has been
• Endophthalmitis no proven advantage of the same; rather the inci-
• Retinal detachment dence of postoperative hypotony (10–63%), flat
• Optic nerve damage following posterior posi- anterior chamber (18–43%), choroidal effusions
tioning of Ahmed valve (>71%), sclera melt, conjunctival erosion and
implant exposure were found to be increased.
In the Tube Versus Trabeculectomy Study,
loss of vision of two or more lines at 5 years of
follow-up following glaucoma drainage device 17.11 Summary
implantation occurred in 39% of patients without
surgical complications and 51% of patients with GDDs are viable alternative to trabeculectomy in
surgical complications. most of the secondary and complicated glauco-
Overall the success rates of drainage implants mas and are a preferred choice of treatment for
in various types of glaucoma are as follows: most of the secondary glaucomas. Proper patient
17  Glaucoma Drainage Devices: Complications and Their Management 125

selection, preoperative assessment, meticulous 2. Ayyala RS, Zurakowski D, Monshizadeh R,


et  al. Comparison of double-plate Molteno and
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randomized, masked, prospective study. J Glaucoma.
References 1998;7:240–6.
13. Costa VP, Azuara-Blance A, Netland PA, et  al.

Efficacy and safety of adjunctive mitomycin C dur-
1. Schwartz KS, Lee RK, Geddee SJ.  Glaucoma
ing Ahmed glaucoma valve implantation: a pro-
Drainage implants: a critical comparison of types.
spective randomized clinical trial. Ophthalmology.
Curr Opin Ophthalmol. 2008;17:181–9.
2004;111:1071–6.
Postoperative Care and Follow-Up
of the Patient with Glaucoma 18
Drainage Devices

Sushmita Kaushik and Gunjan Joshi

Glaucoma drainage devices (GDDs) channel the continued for 2 weeks while the steroid be con-
aqueous from the anterior chamber of the eye tinued for around 8–12  weeks depending upon
through a tube to an equatorial plate. GDDs have the intensity of inflammatory reaction.
become the primary surgery of choice in refrac- It is important to know the complications
tory glaucomas like post-penetrating keratoplasty related to the valved and nonvalved devices at
glaucoma, glaucoma following retinal surgery, different time points of postoperative period and
neovascular glaucoma, and irido-corneal endo- their timely management for optimal results.
thelial syndrome and in patients with scarred These complications are summarized in Fig. 18.1.
conjunctiva. They are frequently used in cases Complications in immediate postoperative
with failed trabeculectomy surgery also. period include:
The GDDs can be classified into valved and
nonvalved devices. Currently the most common 1. Hypotony-related complications are a rela-
GDDs used are the valved Ahmed Glaucoma tively common problem in the early postop-
Valve (AGV) or the non-valved Baerveldt erative period. Studies [1, 2] have shown a
Glaucoma Implant (BGI). Recently, the Aurolab higher rate of persistent hypotony-related
Aqueous Drainage Implant (AADI) has been complications after Baerveldt implant com-
introduced which is similar in design to the BGI. pared to AGV. Reasons for hypotony in imme-
The postoperative care following both these diate postoperative period are mentioned as
implants aims at stabilization of the intraocular follows.
pressure (IOP), early recognition, and appropri- (a) Reasons for hypotony in immediate post-
ate management of the complications. operative period:
The standard care post GDD implantation • Overfiltration through a valved device
includes use of topical antibiotic and topical cor- • Peritubal leakage
ticosteroid drops six to eight times in a day. Also, • Incomplete occlusion of a nonvalved
antiglaucoma medications need to be given in device
patients implanted with non-valved implants • Severe inflammation causing ciliary body
since the tube is occluded to prevent early post- shutdown and aqueous hyposecretion
operative hypotony. The antibiotic needs to be
Treatment for hypotony has to be directed against
the specific cause. Hypotony may also occur fol-
lowing release of the tube ligature in nonvalved
S. Kaushik (*) · G. Joshi devices. These patients need to be carefully
Advanced Eye Center, PGIMER, Chandigarh, India

© Springer Nature Singapore Pte Ltd. 2019 127


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_18
128 S. Kaushik and G. Joshi

Fig. 18.1 Complications Complications in post-operative period


in postoperative period

Early Late

1. Hypotony &related 1. Tube or plate erosion


complications 2. Tube retraction
2. Ligature release in 3. Strabismus
nonvalved implants
3. Corneal decompensation
4. Overhanging bleb
5. Suprachoroidal hemorrhage
6. Hypertensive phase in
valved implants
7. Conjunctival flap retraction
8. Tube or valve obstruction
9. Endophthalmitis

a b

Fig. 18.2 (a) Fundus photographs of a 9-year-old apha- Same child as in (a) after a short course of systemic ste-
kic child who underwent Baerveldt implant, with massive roids. Choroidal effusion has resolved well
exudative retinal detachment secondary to hypotony. (b)

­ onitored for IOP, and the antiglaucoma medica-


m drainage. Management of hypotony-­related com-
tions have to be titrated in them from time to time plications is summarized below.
as ligature opening is a gradual process. (b) Management of hypotony-related
complications:
Hypotony-related complications include choroi- • Frequent topical steroids and oral ste-
dal effusions and shallow anterior chamber roid to reduce choroidal effusion
(Fig. 18.2a, b). The reported incidence of choroi- • Cycloplegic to deepen anterior
dal effusion was 10–18% in various studies [1, chamber
2], but in the Tube Versus Trabeculectomy study • Anterior chamber (AC) reformation
[3], only 1.8% of choroidal effusions required with high-viscosity viscoelastic if fl
­ at/
18  Postoperative Care and Follow-Up of the Patient with Glaucoma Drainage Devices 129

very shallow AC with lenticulo-corneal • Increase in cellular reaction in anterior


touch, with significant choroidal chamber.
effusions • Ultrasound B scan if performed will dem-
• Choroidal effusion drainage is required onstrate aqueous lake around the plate fol-
when choroidals do not resolve with a lowing ligature release.
short course of steroids and cyclople-
gic agents If the ligature does not open spontaneously by
Chronic hypotony may occur in eyes with around 8 weeks, ligature release by laser suture
decreased aqueous production due to ciliary lysis is indicated.
body dysfunction or aging. Surgical revision
with reduction in the size of the plate for
Baerveldt implants could be helpful here. 3. Corneal decompensation can result from tube
Permanent tube ligation and surgical removal of touch to the cornea either due to improper
the implant with closure of scleral fistula may be placement of tube into anterior chamber or
necessary in some cases. due to persistently flat anterior chamber from
hypotony (Fig. 18.4a, b).
The risk of graft failure in post-penetrating
2. Ligature release The tube of nonvalved keratoplasty eyes is high. The problem can be
devices is occluded with polyglactin suture to avoided by proper tube placement and by
delay aqueous outflow till fibrous encapsula- using valved implants that better maintain the
tion of plate has started. Hypotony is the anterior chamber depth better. Pars plana tube
major problem with a loose ligature or prema- placement helps in avoiding corneal or graft
ture opening of the ligature. The 6-0/7-0 poly- decompensation.
glactin suture generally releases around 4. Overhanging bleb occurs if the patch graft is
6–8  weeks postoperatively (Fig.  18.3a, b). too thick or the plate is too anterior. An over-
Signs of ligature release are as follows. hanging bleb can lead to chronic dellen for-
(a) Signs indicating ligature release: mation and ocular irritation. This complication
• Lowering of IOP. can be prevented by appropriate placement of
• Elevation of the conjunctiva overlying the the plate and graft during surgery.
plate by fluid with obscuration of the plate 5. Hypertensive phase is defined as IOP elevation
margins (Fig. 18.3). of >21  mmHg in the first 6 postoperative

a b

Fig. 18.3 (a) Note the partial obscuration of the AADI plate in the same patient at 9 weeks after implantation as
plate at around 7 weeks after implantation as the ligature the ligature has opened up completely
opens up. (b) Note the complete obscuration of the AADI
130 S. Kaushik and G. Joshi

a b

Fig. 18.4 (a) Note the excessively long tube touching the cornea in a uveitic patient. (b) Same patient after reposition-
ing of the trimmed tube

months after an initial IOP reduction to • Tissue plasminogen activator (0.1–0.2 ml


<22 mmHg in the first postoperative week [4]. of 5–20 μg) may be beneficial to dissolve
The reason for this is the resistance of the the blood clot occluding the tube.
fibrous tissue of the capsule to passive flow of 7. Conjunctival flap retraction can occur due to
aqueous [5]. This phase commonly occurs inadequate anchorage of the conjunctiva to the
1–2 months post GDD implantation and may ocular coats. It is also seen in patients with
persist from weeks to several months. Aqueous multiple previous surgeries, those on pro-
suppressants need to be given in this period as longed immunosuppression like those with
aqueous is thought to contain cytokines that uveitis probably due to altered healing
stimulate collagen formation. Early initiation response. Conjunctival resuturing after fresh-
of aqueous suppressant was found to be bene- ening of the conjunctival edges with a nonab-
ficial in reducing IOP spike in patients follow- sorbable suture like 9-0 nylon is the first line of
ing AGV implantation in a recent study [4]. treatment. Patients with recurrent conjunctival
If the hypertensive phase fails to respond to retractions require a conjunctival autograft,
aqueous suppressants and bleb massage, bleb from the same or fellow eye (Fig. 18.5a, b).
needling with mitomycin C can be done.
6 . Tube or valve obstruction can result in pro- Late complications of GDD implantation
found IOP elevation. It can be distinguished include:
from the hypertensive phase by noting the
absence of aqueous lake around the plate clin- 1. Tube or plate erosion may occur through the
ically and can be confirmed by ultrasound B sclera patch (Fig. 18.6a, b) or through the con-
scan. Occlusion at the tube tip can be due to junctiva. It most commonly occurs just at or
vitreous, fibrin, blood clot, iris, neovascular, posterior to the limbus. Covering the tube
or endothelial membranes, while the lumen with a patch graft like sclera/cornea/pericar-
can be obstructed by fibrin or clotted blood. dium/amniotic membrane/fascia lata
Treatment involves removal of the occluding decreases the risk of tube erosion.
material. Alternatively, a sclera tunnel can be made, and
(a) Methods to remove material occluding the the tube can be placed beneath it without a
tube: sclera patch. Tube erosion (Fig. 18.7) if pres-
• Nd:YAG laser in relieving obstruction ent warrants prompt surgical intervention as
from the fibrin and iris. an exposed tube can be a scaffold for infection
• Vitrectomy for vitreous removal. and can lead to endophthalmitis. The surgery
18  Postoperative Care and Follow-Up of the Patient with Glaucoma Drainage Devices 131

a b

Fig. 18.5 (a) Conjunctival retraction and exposure of the scleral patch graft in a 6-year-old child with inferotemporal
Baerveldt implant. (b) Same child 3 days post conjunctival resuturing with nonabsorbable 9-0 nylon suture

a b

Fig. 18.6 (a) Tube exposure through the scleral patch. (b) Same patient after tube explantation and covering the defect
with sclera patch and conjunctiva

involves mobilization of the conjunctiva on


either side of erosion and repositioning of the
tube after washing it with antibiotic-BSS solu-
tion. The tube is then covered with the patch
graft. The healthy mobilized conjunctiva is
then pulled forward to cover the patch graft.
Plate erosion if present requires removal of
the plate and closure of the conjunctival defect
(Fig. 18.8).
2 . Tube retraction may occur later in the course
despite careful surgical technique. Tube
retraction and anterior migration are seen
more commonly in children due to growth of
Fig. 18.7  Plate exposure. The patient finally underwent the eyeball. If present a tube extender can be
plate explant attached, and the tube can be reinserted in
132 S. Kaushik and G. Joshi

Management post GDD implantation in early postoperative period

Concerns in valved implants Common concerns in all GDDs Concerns in non valved
implants

Wound architecture
Tube position IOP

Conjunctival retraction
If corneal/ lenticular
touch present
Conjunctival resuturing

Tube repositioning
High IOP

Overfiltration due to impaired Normal AC and


Low IOP Shallow AC
valve mechanism posterior
segment
Choroidal
effusion Look for YES Lenticulo- Rule out
Shallow AC with irido- corneal touch Rule out Tube NO Give suprachoroidal
YES corneal touch occlusion Aqueous hemorrhage and
suppresants Malignant
NO glaucoma
Add oral steroid YES

NO Relieve tube
Frequent topical steroids and YES occlusion
cycloplegic
If not responding to oral steroid/ Incomplete tube occlusion
360° kissing choroidals/high risk Premature ligature release
of 2% complications
Consider choroidal AC reformation
drainage

Fig. 18.8  The schematic flow chart of the management of post operative complications following GDD implantation

desired position. Alternatively a long tube can


be trimmed short. valved implants like the AGV. One has to
3. Strabismus leading to intractable diplopia is be vigilant for serious complications such
related to the location of the plate and the as large choroidal effusions, conjunctival
height of the bleb. Placement of the tube in retraction, tube and plate erosions, etc. A
superonasal quadrant can cause entrapment of standardized protocol will ensure a good
the superior oblique tendon secondary to fibro- surgical outcome.
sis leading to Brown’s syndrome. One should
also avoid inferior quadrants due to poor cos-
mesis and risk of diplopia. The height of the
bleb can be reduced by needling. Intractable
diplopia requires removal of the GDD [6]. References
1. Christakis PG, Tsai JC, Kalenak JW, et al. The Ahmed
Summary versus Baerveldt study: three-year treatment out-
comes. Ophthalmology. 2013;120:2232–40.
The postoperative care of patients after 2. Budenz DL, Barton K, Feuer WJ, et  al. Treatment
GDD implantation involves meticulous outcomes in the Ahmed Baerveldt Comparison
clinical evaluation. The IOP should be Study after 1 year of follow-up. Ophthalmology.
closely monitored especially during the 2011;118:443–52.
3. Gedde SJ, Herndon LW, Brandt JD, et al. Postoperative
time of ligature release in non-valved complications in the Tube Versus Trabeculectomy
implants and the hypertensive phase in (TVT) study during five years of follow-up. Am J
Ophthalmol. 2012;153:804–14.
18  Postoperative Care and Follow-Up of the Patient with Glaucoma Drainage Devices 133

4. Lieberman MF, Ewing RH.  Drainage implant sur- dure: a randomized prospective trial. J Glaucoma.
gery for refractory glaucoma. Int Ophthalmol Clin. 2016;25(3):248–57.
1990;30:198–208. 6. Ball SF, Ellis G, Glenn Herrington R. Brown’s supe-
5. Law SK, Kornmann HL, Giaconi JA, et  al. Early rior oblique tendon syndrome after Baerveldt glau-
aqueous suppressant therapy on hypertensive coma implant. Arch Ophthalmol. 1992;110(10):1368.
phase following glaucoma drainage device proce-
Histological Considerations
of Glaucoma Drainage Devices 19
Nadia Ríos-Acosta and Sonia Corredor-Casas

19.1 Introduction

The fundament of glaucoma surgery is to artifi-


cially create an additional pathway for aqueous
humor outflow, with a consequent lowering of
IOP (Fig. 19.1).
Scarring of the filtration bleb is an important
enemy of these procedures with subsequent
reduction or abolition of aqueous flow to the sub-
conjunctival space. For this reason wound heal-
ing response is the most important determinant of
the final IOP and success rates. The key compo- Fig. 19.1  Trabecular meshwork with normal appearance
nents involved in filtration failure are Tenon’s by light microscopy in a patient with POAG (H&E stain)
capsule and the episclera.
Aqueous humor contains an important amount
of growth factors (TGF-β, basic fibroblast growth
factor, epidermal growth factor, insulin-like
growth factor-1 (IGF-1), and platelet-derived 19.2 Conjunctival Wound Healing
growth factor); several of these factors contribute
to the wound healing response as chemotactic of Typical glaucoma filtration surgery differs from
mitogenic factors for fibroblasts [1]. other surgical procedures due to the need of
alteration of normal wound healing to achieve
success [2].

1. Wound healing phases [3]:


(a) Coagulative
Disrupted tissue leads to leakage of
plasmatic proteins and blood cells.
N. Ríos-Acosta (*) Coagulation cascade is activated, and
University of Manitoba, Winnipeg, MB, Canada clotting factor activation leads to conver-
S. Corredor-Casas sion of fibrinogen to fibrin for the genera-
Instituto Mexicano de Oftalmologia, tion of clot to stop leakage.
Queretaro, Mexico

© Springer Nature Singapore Pte Ltd. 2019 135


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_19
136 N. Ríos-Acosta and S. Corredor-Casas

(b) Inflammatory
After the formation of clot, signal-
ization begins. Proteins (histamine,
serotonin, prostaglandins, and leukotri-
enes), cytokines (interleukin-1 and
interferon-­ a2b), and growth factors
send signals leading to cellular migra-
tion and attraction of white blood cells
such as neutrophils, macrophages, and
lymphocytes [3, 4].
• Most of the growth factors involved are
upregulated in the aqueous of glaucoma
patients and can increase the proliferation
of Tenon’s fibroblasts by 60% compared Fig. 19.2  A thickened fibrotic peri-valvular wall, demon-
with the aqueous humor of normal persons strating a more densely portion proximal to the plate and
a distal vascularized and loose portion (Masson Trichrome
[4], generating a higher risk of scarring, stain)
especially on drainage devices where speed
and area of exposition are greater.
(c) Proliferation and Repair giant cells. In this reaction TGF-B is a main
Endothelial cells and fibroblast migrate mediator in the encapsulation of the device and
into the injured tissue with subsequent subsequent fibrosis [9].
angiogenesis and formation of granula- When the bleb wall formation is studied
tion tissue. through imaging with anterior segment optical
(d) Remodeling coherence tomography, it has shown to have a
Cross-linking of collagen type I and elastin is hyperreflective wall, implying dense fibrotic cap-
induced by fibroblasts leading to the forma- sule formation on early stages, whereas after tra-
tion of dense scar tissue. Blood vessel regres- beculectomy the blebs have multiple
sion occurs in this phase [3–5]. subconjunctival fluid collections with a thinner
On failed blebs of drainage implants, type IV fibrotic layer [10, 11]. Hence their subsequent
collagen and laminin are found denser and on behavior on aqueous filtration is different
higher amounts than non-failed blebs as well (Fig. 19.2).
as an increased pattern of ECM component It has also been postulated that different mate-
expression [6]. rials, area, and design of the implant have an
influence on scarring behavior.
Materials have been developed for the
19.3 S
 carring of Drainage Devices implants taking into account their reaction and
vs. Scarring in Filtration viability; the most commonly used have been
Surgery polypropylene and silicone. Silicone has been
found to be less inflammatory than polypropyl-
Wound healing response differs in glaucoma ene [12].
drainage devices from that following trabeculec- It has been suggested that the delay on aque-
tomy because a foreign body is inserted and there ous outflow on delayed drainage in implants with-
is a different distribution, speed, and rate of aque- out a flow restriction mechanism may be beneficial
ous outflow [7]. On animal models, the extent of through the delay of pro-inflammatory factors in
scarring after 10  days is greater on drainage aqueous outflow. Molteno implant bleb capsules
devices than after filtration surgery [8]. (polypropylene implant without a valve mecha-
Foreign body reaction is characterized by a nism) have shown breakdown of collagen and pro-
collagen-rich capsule with a few foreign body gressive reduction in the cellularity of tissue;
19  Histological Considerations of Glaucoma Drainage Devices 137

Table 19.1  Risk factors for filtration failure due to sec- On valve implant, other than the regular post-
ondary scarring [14, 15]
operative scheme, few studies have found
High risk of scarring encouraging results using steroids; the use of
• Age under 40 sub-Tenon’s injection of 10 mg of triamcinolone
• African–Caribbean descent
acetonide has proved to reduce mean IOP for up
• Previous ocular inflammation (including surgery
and topical medications) to 1 year [18].
• Uveitis
• Anterior segment neovascularization
Low/medium risk of scarring 19.4.2 Antimitotic Agents
• Previous topical medications
• Age under 40 Their main action mechanism is the inhibition of
• Thin or scant Tenon’s capsule activation of fibroblasts. The most commonly
used are 5-fluorouracil and mitomycin C. 5-FU is
however no difference has been found between associated with fewer side effects than mitomy-
the bleb capsule staining whether the bleb cap- cin C but has been proved to be less effective
sule had been perfused with aqueous humor improving the surgical outcome [19–21].
immediately after surgery or after a delay [6].
After Ahmed valve implantation, a rise of 19.4.2.1 5-Fluorouracil
intraocular pressure around 3–6 weeks after the 5-Fluorouracil is a chemotherapeutic agent, a
surgery is found; this hypertensive phase has not pyrimidine analogue that antagonizes pyrimidine
been commonly observed with the Baerveldt metabolism, interferes with the synthesis of thy-
implant [13]. midine nucleotides [22], and affects DNA syn-
Independently on the device to be implanted, thesis by acting selectively on the synthesis phase
necessary measures to modulate wound healing of cell cycle, so its principal effect acts on divid-
in any glaucoma surgery include gentle handling ing cells. It is an effective long-lasting inhibitor
of soft tissues, control of intraoperative bleeding, of human Tenon’s fibroblast growth [23] and
and pharmacological perioperative treatment alters their function reducing the formation of
(Table 19.1). collagen type 1 and fibronectin. High levels lead
to toxicity and apoptosis of all replicating tissues
[24]. Bleb leaks, corneal toxicity, and endo-
19.4 Common Modulators phthalmitis have been reported after subconjunc-
for Wound Healing tival injections of 5-FU [23].

19.4.1 Corticosteroids 19.4.2.2 Mitomycin C


MMC is a chemotherapeutic agent with antipro-
Their action mechanism is suppression of leuko- liferative properties [4] isolated from the fermen-
cyte concentration and function, alteration of tation filtrate of the Streptomyces caespitosus
vascular permeability which leads to local tissue fungus [2]. Its action mechanism is the inhibition
disruption, diminished fibroblast activity, and of Tenon’s fibroblasts and endothelial cell prolif-
wound healing [3]. eration [3].
The use of corticosteroids may increase IOP Its active metabolite is an alkylating agent that
on steroid-responsive patients (18–36% of gen- cross-links DNA; it interferes with any phase of
eral population and 46–92% of patients with pri- the cell cycle causing inhibition of DNA replica-
mary open-angle glaucoma) [16]. This adverse tion, mitosis, and protein synthesis [3]. In com-
reaction is attributed to increased deposition of parison with 5-fluorouracil, mitomycin C
extracellular matrix and altered trabecular mesh- generates permanent apoptosis mediated by the
work cell function which causes disturbed aque- activation of caspase-3, caspase-9, Fas, Bad, and
ous humor outflow [17]. phosphorylated p53 in human Tenon’s fibroblasts
138 N. Ríos-Acosta and S. Corredor-Casas

[25]. Its effect is dependent of the dose, surface main isoforms associated with Tenon’s fibroblast
area, and time of exposition. proliferation [33].
Although there is activation of fibroblasts on
tube surgery, the evidence in support of using 19.4.4.1 Bevacizumab
MMC is controversial [2]. Intravitreal injection of bevacizumab has been
In some studies the use of adjuvant mitomycin shown to cause regression of iris and angle neo-
C with double-plate Molteno implants has offered vascularization in eyes with neovascular glau-
an increase of 2–3 years of medication-free con- coma [34].
trol compared to similar patients receiving 5-FU The adjunctive use of bevacizumab during
or no antimetabolite therapy. Applied intraopera- AGV implantation has significantly enhanced
tively with Ahmed valve on neovascular glau- shunt survival; it also seems to be much safer
coma patients and refractory glaucoma patients, than MMC with no visually devastating compli-
no benefit has been found on survival against no cations [35–37].
antimetabolite [26, 27]. Antimetabolites seemed to be more effective
Different administration techniques have been in lowering IOP, but overall there has not been
proposed, such as using a layer of cotton soaked significant difference in defined success rate [38]
with MMC at 0.25–0.33  mg/ml, encompassing (Fig. 19.3).
the valve plate onto the sclera for 2–5 min with Van Bergen et al. [39] reported that periopera-
better results and less complications [28]. Still tive use of intracameral bevacizumab led to a
there is no sufficient evidence to establish a significant reduction of bleb needling interven-
guideline on this matter. tions postoperatively and a higher surgical suc-
Other authors have suggested intraoperative cess rate which was equal to the MMC antifibrotic
use of subconjunctival MMC and postoperative effect but with a better safety profile and less
subconjunctival injections of 5-FU [29]. VEGF upregulation in bevacizumab-injected
mice [40].
Subconjunctival injections have also been
19.4.3 TGF-B Inhibitors used to modulate scarring, using bevacizumab
1.25–2.5 mg with significative lowering on IOP
Higher levels of TGF-B and other growth factors at days 15 and 45 [41, 42].
favor wound healing in aqueous humor of glau-
coma patients [30]. This factor stimulates Tenon’s
fibroblasts in  vitro and enhances fibroblast-­
mediated collagen contraction and scarring [4].
Studies performed in animal models show
promising results with less collagen deposition
and evidence of bleb formation in trabeculec-
tomy without side effects [31]. However there is
still much more to research about drainage
implants.

19.4.4 VEGF Inhibitors

VEGF promotes migration of inflammatory cells Fig. 19.3  Microscopic image showing a decreased cel-
and induces angiogenesis, indirectly stimulating lularity of trabecular endothelium from a POAG patient
fibrosis [32]. VEGF 121 and VEGF 165 are the biopsy (H&E stain)
19  Histological Considerations of Glaucoma Drainage Devices 139

19.4.5 Postsurgical Fibrosis 19.5 Future Perspectives


Treatment
Newer design and material for devices are being
19.4.5.1 Digital Massage proposed; microfluidic meshwork valve devices
Digital massage is an option in the hypertensive have shown good experimental results with a
phase of glaucoma drainage implants [43, 44]. thinner fibrotic capsule compared to the AGV
The purpose of digital massage is to force AH PF7; however they still are on experimental phase
through the tube, open the valve mechanism, and [48].
reduce scar formation. The most commonly One of the newest medications suggested for
described technique is to have the patient mas- scarring treatment is pirfenidone (5-methyl-­ 1-
sage the inferior part of their closed and supra- phenyl-2[1H]-pyridone), a modified derivative of
ducted eye through the inferior eyelid with two pyridine. It is currently used as one of the main
fingers for up to a minute; this would hydrodis- treatment options for idiopathic pulmonary
sect Tenon’s encapsulation [45]. fibrosis.
Its precise molecular mechanisms have not
19.4.5.2 Needling yet been elucidated. But there seems to be sup-
Needling with or without 5-FU has been pro- pression of connective tissue growth factor
posed as postoperative treatment on hypertensive (CTGF), platelet-derived growth factor,
phase. α-smooth muscle actin (α-SMA), and TGF-β1.
Bleb needling with 5-FU with patients In vitro, pirfenidone was found to suppress pro-
implanted with an S2 AGV, noncontrolled IOP, liferation and collagen contraction of human
and encapsulated bleb over the plate has shown a Tenon’s fibroblasts.
high qualified success [46]. On experimental trials in rabbits, intrableb
injection with a posterior topical application has
19.4.5.3 Cyst Excision demonstrated less proliferation of fibroblasts and
When medical therapy fails to control scarring, a suppressed transformation of fibroblasts into
Tenon’s cyst excision may be performed. myofibroblasts, lower degree of cellularity at
Conjunctiva is dissected over the encapsulated 2 weeks after operation, and a reduced thickness
bleb, and the cyst wall is excised (Fig.  19.4). of the collagen layer by decreasing TGF-B sig-
After excision, the conjunctiva is closed with a naling [49].
nylon or vicryl suture. In a retrospective study by Recent evaluation of the antifibrotic effects of
Eibschitz-Tsimhoni et  al., surgical revision was PFD versus 5-FU and MMC in  vitro demon-
effective in achieving adequate IOP control in 8 strated that 5-FU was the least cytotoxic and that
of 11 patients, with or without medications [47]. the antifibrotic effect of PFD and MMC was sim-
ilar and higher than 5-FU [50].
There are also two proposed release drug
delivery systems using poly-2-hydroxyethyl
methacrylate (P-HEMA) and poly(lactic-co-­
glycolic acid) (PLGA). The study evaluated the
nonbiodegradable P-HEMA with MMC and the
biodegradable PLGA with 5-FU systems with
and without MMC for their ability to reduce
fibrosis when attached to an Ahmed glaucoma
valve in a rabbit model. The results showed sig-
nificant decrease in in  vivo bleb roof thickness,
ocular injection, ocular inflammation, and overall
Fig. 19.4  Extracellular calcium deposits at the proximal fibrosis in the group with concomitant usage of
portion of a filtering bleb (PAS stain) 5-FU, MMC, and PLGA [45, 51].
140 N. Ríos-Acosta and S. Corredor-Casas

Science still has not found the ideal wound silicone Ahmed glaucoma valves. Ophthalmology.
2006;113(8):1320–6.
healing modulator for filtration surgery, the 13. Bhartiya S, Shaarawy T. Chapter 113: Surgical tech-
adverse effects of antimitotics and steroids are nique 3 (Ahmed glaucoma valve drainage implant).
still a setback for their general use, and results In: Boyle IV JW, Ryan McManus J, Netland PA, edi-
with drainage implants are mixed. However the tors. Glaucoma. 2nd ed. Edinburgh: Elsevier Limited;
2015. p. 1078.
new development of devices and application of 14. Fraser S.  Trabeculectomy and antimetabolites. Br J
newer medications brings new light to future suc- Ophthalmol. 2004;88(7):855–6.
cess in these surgeries. 15.
European Glaucoma Society Editrice Dogma.
Terminology and guidelines for glaucoma. 2nd ed.
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Economic Considerations
of Glaucoma Drainage Devices 20
Maneesh Singh and Arijit Mitra

20.1 Introduction Numerous studies have demonstrated that


reduction of intraocular pressure reduces the risk
Glaucoma is the second leading cause of blindness of visual field loss in glaucoma and prevents blind-
and the leading cause of irreversible blindness in the ness [2, 3]. Medical management and lasers play a
world. It is estimated that there will be around 79.6 very important role in preventing the progression
million people with glaucoma worldwide by the year of glaucoma in an affected individual. When it
2020. In the United States, itself around three mil- comes to surgical management,  Trabeculectomy
lion people are affected by glaucoma and this num- and Glaucoma drainage devices are the two most
ber will increase to around six million by 2050 [1]. prevalent surgical options for glaucoma and the
In India around 12 million people are currently published data from the TVT (Tube versus
affected by the disease and the number is expected to Trabeculectomy) study has shown similar intraoc-
rise to around 16 million by the year 2020 [1]. ular pressure control in tube patients compared to
Glaucoma has a significant impact on the life trabeculectomy patients [4, 5].
of an affected individual because as the field of The number of glaucoma patients is likely to
vision decreases in one or both the eyes, it mark- increase significantly in the future due to population
edly lowers the patients’ ability to perform the growth, increased life expectancy and better detec-
activities of daily living, deteriorating the quality tion. It will have a huge economic impact on the
of life and increases the  requirement for social health systems of the world. In an estimate the dis-
care and support services. Besides direct costs ease cost of glaucoma in the United States, Australia
like inpatient and outpatient expenses, health vis- and Finland is about seven million USD per million
its, cost of medications, nursing care and social inhabitants (2003–2004). Indirect costs have been
services, glaucoma also causes absence from reported to be much higher. Considering that the
work and lost productivity. population of Europe has >800 million inhabitants
and the United States has >300 million inhabitants,
the yearly investments in glaucoma care are signifi-
cant and increase with ageing population [6].
It is extremely important for us to understand
the economics of glaucoma and to prepare the
M. Singh (*)
Glaucoma and Cataract Services, B.B. Eye
infrastructure to combat the increasing costs and
Foundation, Kolkata, India demand of glaucoma care. We also need to pro-
A. Mitra
vide our patients with affordable medical and
Glaucoma and Cataract Services, Disha Eye surgical treatments to make the glaucoma man-
Hospitals Pvt. Ltd., Kolkata, India agement cost-effective.
© Springer Nature Singapore Pte Ltd. 2019 143
M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_20
144 M. Singh and A. Mitra

20.2 Glaucoma in Developing The cost of medical management of glaucoma


Countries has been increasing over the years. Lam et  al.
have explored the trends in glaucoma medication
The major population of the world resides in expenditure, and they concluded that the factors
developing countries. As per Quigley there are associated with increasing glaucoma medication
12.3 million people in the world who are blind expenditure trends include the increasing use of
due to glaucoma, and 70 million people are suf- prostaglandin analogues, changes in insurance
fering from glaucoma [1]. As  the  rate of angle-­ coverage, and possibly more aggressive glau-
closure glaucoma is higher in the Asian population coma treatment [8]. In the Western world, the
and open-angle glaucoma in African population, major cost of treatment is borne by insurance
a vast majority of patients with glaucoma reside companies; however in developing countries like
in developing countries. India, the cost of therapy is mainly borne by the
Lack of awareness of the  disease is also a patient himself. In a study from a tertiary eye care
major concern. As glaucoma is a silent disease hospital in India, less than 10% of their patients
and is practically symptomless, most patients are got their bills reimbursed by medical insurance
detected late. Lack of education and regular eye [4]. Because of self-financing, a lot of newer and
check-up also contributes to late detection of generally costlier treatment interventions are not
glaucoma. Due to poor awareness, these patients available in the developing world and even when
are not willing to use medicines regularly or available have poor acceptance. Very few studies
undergo glaucoma interventions. from India have tried to assess the cost of therapy
Cost is a major issue in these countries along for glaucoma patients [4]. In fact there are none
with poor availability of medications, lack of which have studied the cost-effectiveness of
health insurance and extremely poor adherence glaucoma drainage devices in the developing
to therapy. Due to all these factors, often surgery world. Most of the available data is from Western
is considered as a primary treatment modality in literature. If one understands the finances better,
these countries. According to the United Nations one can better utilise the available resources. It is
and World Bank, more than 1.3 billion people essential to choose the treatment which is most
worldwide live on less than 1 USD per day, and affordable and economically viable for the target
most of them reside in developing countries [7]. patient group.
Glaucoma surgery compared to cataract sur- In developing countries like India, a large
gery cannot improve vision but rather may lead to chunk of people belong to the low-income
vision threatening complications. Hence it is often group, and for them the affordability of drugs is
avoided by ophthalmologists and poorly accepted a major issue. Even trabeculectomy too is often
by patients too. As the number of glaucoma sur- not affordable. Hence glaucoma drainage
geries is going down, a lot of practising ophthal- devices (GDD), due to their higher cost, remains
mologists are not competent in performing a big prohibition for patients and their care
reasonably successful trabeculectomies. Lack of providers.
experience of surgeons and poor confidence result For glaucoma drainage devices, cost is a major
in poor surgical outcome and ultimately result in issue. The surgical time taken in glaucoma sur-
a bad name for the glaucoma surgery. The number gery is more than routine cataract surgery making
of trained specialists who can perform glaucoma it less cost-effective (less profitable) for institu-
drainage device surgery is even fewer. tions. Study done in a tertiary care centre in India
Surgical cost is high initially, but once suc- has shown that more than 50% of patients had
cessful the cost goes down as there is lesser need income of less than 5000 rupees (80 USD) per
of medication and lesser follow-up in the long month; hence affording an Ahmed glaucoma
run. However, even in developing countries, the valve  costing nearly 15,000 Indian rupees (260
rate of glaucoma surgeries is low primarily due to USD) is difficult [4]. As per Nayak and group,
poor acceptance of trabeculectomy and its unpre- per month expenditure on drugs was between
dictability [4]. USD 8.2 and USD 307.09 with an average of
20  Economic Considerations of Glaucoma Drainage Devices 145

USD 65.6 per month [4]. Acceptance of surgery Concurrently the number of trabeculecto-
was poor, and when given as option, only 4% of mies decreased from 51,690 in 1995 to 24,178 in
patients opted for surgery as primary treatment 2004 (53% decrease) [12].
versus lifelong medication. Anand et al. however
have noted a much better acceptance of primary
surgery after proper counselling [9]. They have 20.3.1 Indications of Glaucoma
shown that 35% of patients accepted early sur- Drainage Devices
gery which increased to 65% on proper counsel-
ling and educating patients about glaucoma. Survey among members of the American
Glaucoma Society has noted eight main condi-
tions where shunts have become a primary surgi-
20.2.1 How Funding Can cal choice for more than 50% of its members
Be Improved (2008) [13]. The eight major indications of shunts
are:
1. Government or private health insurance, at a
nominal premium, needs to be made popular. 1 . Previously failed trabeculectomy
Glaucoma shunt surgery too needs to be cov- 2. Previous intra- or extracapsular cataract

ered by these policies. extraction
2. Government subsidy: Government may pro- 3. Previous phacoemulsification
vide subsidy to not-for-profit hospitals per- 4. Post-penetrating keratoplasty
forming glaucoma surgery including shunts. 5. Post-scleral buckle
Tax rebate on glaucoma shunts too can 6. Post-pars plana vitrectomy
enhance the popularity of these devices. 7. Uveitic glaucoma
3. Corporate social responsibility: Corporates
8. Neovascular glaucoma
may be requested to sponsor glaucoma shunt
surgery in charitable hospitals catering to Aqueous shunts are currently the standard of care
patients of low-income group. for complicated glaucoma in the United States
especially in pseudophakic eye with previous one
or more failed trabeculectomies [10]. The long-­
20.3 Glaucoma Drainage Devices term success is comparable to trabeculectomy;
however trabeculectomy may provide lower IOP
Aqueous shunts or glaucoma drainage devices compared to shunts. The failure rate of shunts is
(GDD) are used as surgical intervention to con- approximately 10% per year which is quite simi-
trol IOP (intraocular pressure) in patients with lar to trabeculectomy [14].
advanced glaucoma with failed standard surger-
ies like trabeculectomy or in patients with glau-
coma subtypes where trabeculectomy is unlikely 20.4 Cost-Efficacy of Treatment
to succeed [10, 11]. Molteno implant was the first
widely used glaucoma drainage device. Newer Effectiveness describes outcome of a treatment
shunts like Baerveldt contain single plate without modality in everyday practice, and it is always
a flow-restrictive mechanism, while Ahmed glau- worse than efficacy which is the outcome of an
coma valve  contains a flow-restrictive valve to intervention in an ideal setting like randomised
reduce post-operative hypotony [10]. control trial. Unless an intervention is both effi-
The use of aqueous shunts is increasing. A cacious and cost-effective, it cannot be clinically
study of Medicare fee for service data  in the useful. Management of glaucoma is getting cost-
United States reported that the number of aque- lier over time as most glaucoma medications are
ous shunt procedures in Medicare  beneficia- expensive and there is a trend among practising
ries  increased from 2728 procedures in 1995 to ophthalmologists to use newer medications
7744 procedures in 2004 (184% increase). which are generally costlier [15].
146 M. Singh and A. Mitra

20.4.1 Types of Economic Analysis drainage devices are not more effective than trab-
eculectomy if the patient does not have risk factors
Most economic analysis considers the cost of ill- for increase in conjunctival fibrosis.
ness or cost of the condition. It basically analyses The Cochrane review of medicines versus sur-
the natural history of illness, untreated impact of gery for open-angle glaucoma stated that in
disease on productivity, overall morbidity as well severe glaucoma (MD  >  10  dB), initial surgery
as total cost of treatment modalities [16]. (trabeculectomy) is associated with marginally
Cost of illness can be divided into cost of the less visual field loss at 5 years than initial medi-
disease itself or the cost of its intervention. The cations [18]. However the study also expressed
cost of disease includes: the view that primary surgery was associated
with more local eye symptoms, more incidence
1. Economic value of disabilities due to loss of of cataract, and reduced visual acuity up to
productivity/time lost at work 5 years of follow-up.
2. Cost of care at home/alternative living facility A more recent Cochrane review on aqueous
due to disease shunts analysed the effectiveness of glaucoma
3. Direct cost of family members or social sup- shunts compared to trabeculectomy [10]. They
port persons to help the individual with the concluded that it was uncertain whether aqueous
disease shunts were safer or more effective than standard
4. Loss of government tax due to loss of produc- trabeculectomy based on the very low certainty
tivity due to illness evidence. They however stated that Baerveldt and
5. Years of life lost due to the disease and its Molteno implants reduced eye pressure more
financial impact than the Ahmed shunt and fewer glaucoma medi-
cations were needed with the former two.
Cost of treatment intervention includes:

1. The cost of care provider (outpatient and


20.6 Cost-Effectiveness
inpatient) of Glaucoma Surgery
2. Cost of drugs
3. Cost of devices and aids There is lack of published data comparing cost-­
4. Productivity loss due to adverse effects of
effectiveness or cost-utility of laser, surgical, or
treatment and its management medical treatment. Worldwide with increased
5. Loss of productivity of family members for number of glaucoma patients, the  number of
assisting in treatment related activities glaucoma prescriptions have increased and so has
the total expenditure on medications. However,
there is a  gradual decrease in the rate of glau-
20.5 Benefits of Glaucoma coma surgeries [19, 20]. The role of laser proce-
Surgery dures (Trabeculoplasty) too has decreased over
time [20].
Various studies have been published highlighting The rate of cataract surgery has been increas-
the efficacy of surgery in glaucoma management. ing worldwide. There is a possibility that lower-
The Finnish evidence-based guideline for glau- ing of IOP (1–4 mmHg) by phacoemulsification
coma stated that not only did surgical management in glaucoma patients might have a protective role
lower the intraocular pressure (IOP) more than for them.
medications and laser treatment but it also resulted Ainsworth and Jay studied 104 glaucoma
in better control of the diurnal variation of IOP patients (newly diagnosed) who received either
[17]. The study also highlighted the fact that early conventional medical therapy (n = 53) or under-
surgical intervention slowed the visual field loss went primary surgery (trabeculectomy) (n  =  51)
progression more than medical or laser treatment. [21]. The total cost in surgery group was twice
However, the study also stated that glaucoma than the conventional therapy  group in the first
20  Economic Considerations of Glaucoma Drainage Devices 147

year, but the cost steadily decreased in the surgery Florida. It became commercially available in
group over the  next few years due to less or no India since June 2013.
need of costly glaucoma medications in the sur- Kaushik et al. have studied the safety and effi-
gery group. The total cost in bilateral cases was cacy of this low-cost glaucoma drainage device
equal in both groups by 8 years of follow-up [21]. (AADI) in patients with refractory childhood glau-
Hence, in the long run, the cost difference in med- coma [23]. They included 34 eyes of 31 patients.
ical versus surgical therapy was not significant. The authors have reported a cumulative success
Kaplan first analysed the cost-effectiveness of of 91.18% at 6 months and 87.7% at 18–24 months.
Baerveldt implant (350 mm2) in comparison with They have concluded that it is a viable low-cost
trabeculectomy with mitomycin C and medical glaucoma drainage device with effectiveness which
management. They observed that glaucoma is comparable to published reports of Baerveldt glau-
drainage devices and trabeculectomy both are coma drainage implant and Ahmed glaucoma valve.
cost-effective procedures. Quality of life and The long-term efficacy of AADI is yet to be
5-year cost burden were markedly similar for established, but it does offer an affordable thera-
glaucoma drainage devices and trabeculectomy peutic option for the glaucoma surgeon in India
compared to medical management. in terms of implant cost alone. Its cost-effectivity
Trabeculectomy had substantially lower cost per with respect to surgical time, multiple interven-
quality-adjusted life-years (QALY) compared to tions, long-term effectiveness and learning curve
tube insertion [22]. is yet to be established.

20.7 Implant Costs 20.8 Summary

Ahmed glaucoma valve (AGV, New world • Worldwide the total number of glaucoma sur-
Medical Rancho Cucamonga California) at USD geries has gone down, but there is an increas-
260, the Baerveldt glaucoma drainage  implant ing trend of the use of glaucoma drainage
(Advanced Medical Optics, Santé Ana California, devices.
USA) at USD 750 are simply beyond the reach of • There is lack of data evaluating cost-­
majority of those who need it the most. effectiveness of glaucoma drainage devices,
Developing countries like India have a large but most available data have found them to be
glaucoma population of which a significant pro- economically viable over a long-term period.
portion of complicated and refractory glaucoma • Availability of low-cost glaucoma drainage
patients need glaucoma drainage devices but can- devices will further enhance the affordability
not afford these costly implants. and use of these shunts.
• We need more studies, specially from
the  developing world, evaluating the cost-­
20.7.1 Low-Cost Implants: Aurolab effectiveness of glaucoma drainage devices in
Aqueous Drainage Implant terms of long-term preservation of visual field.
(AADI)

The Aurolab aqueous drainage implant (AADI)


has been introduced recently by the Aurolab, the References
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2011;129:1345–50. trabeculectomy in glaucoma management changing?
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10. Tseng VL, Coleman AL, Chang MY, Caprioli
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11. American Academy of Ophthalmology Glaucoma
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2017;101(12):1623–7.
Quality of Life Following Glaucoma
Drainage Device Surgery 21
Bernardo de Padua Soares Bezerra, Syril Dorairaj,
and Fabio Nishimura Kanadani

21.1 Introduction disease affects the patient’s daily life, there is


lack of information regarding how glaucoma
Understanding the impact of the disease and its treatment affects one’s quality of life [8–17].
treatment on the patient’s quality of life is an The only multicenter randomized clinical tri-
important aspect of medical care. Good qual- als (RCT) to this date that report quality of life
ity of life is sought after by the vast majority of after treatment intervention are the Collaborative
patients. Initial Glaucoma Treatment Study (CIGTS)
People value their vision highly, more than and the Tube vs. Trabeculectomy study (TVT)
physicians realize [1, 2]. Decrease in visual abil- [18–20].
ity has a direct impact in glaucoma patient’s While the CIGTS looked at recently diag-
quality of life. Serious consequences of reduced nosed glaucoma patients, the TVT study included
vision include fall injuries with reduced mobil- a cohort of patients with a more advanced dis-
ity, increased risk of motor vehicle accidents, and ease profile and was the only RCT up to date to
decreased ability to perform daily life activities address glaucoma drainage device and quality of
[3]. Avoiding obstacles in dim lighting, read- life of patients that had undergone this procedure.
ing through a line, adjusting to shifting light
conditions, and other tasks that require contrast
sensitivity or peripheral vision may become chal- 21.2 Assessing Quality of Life
lenging [4].
A patient-centered approach is considered a Self-reported indicators of quality of life are valu-
best practice to assess the efficacy of emergent able methods of assessing how illnesses affect
and established treatments [5–7]. Although there people. However factors as patient’s emotions,
is extensive information on how glaucoma as a personalities, and psychological considerations
influence subjective perceptions of the effects of
disease and adequacy of vision [21, 22]. Patients
B. de Padua Soares Bezerra (*) are primarily interested in how well they are able
Royal Victorian Eye and Ear Hospital, to function: read signs at a distance, drive, recog-
Melbourne, VIC, Australia nize people, find things in the supermarket, and
S. Dorairaj other daily activities [23].
Mayo Clinic, Jacksonville, FL, USA We better comprehend how the disease
F. N. Kanadani affects patient’s daily lives through generic
Instituto de Olhos Ciencias Medicas, health-­related quality-of-life (QoL) instruments
Belo Horizonte, Brazil

© Springer Nature Singapore Pte Ltd. 2019 149


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_21
150 B. de Padua Soares Bezerra et al.

and vision-specific and also glaucoma-specific domain of interest which patients perceive as ben-
instruments [23]. eficial and which would mandate, in the absence
There are three distinct approaches to mea- of troublesome side effects and excessive cost, a
suring the impact of glaucoma on individuals’ change in the patient’s management [27].
lives [24]: Both the US Food and Drug Administration
and the European Medicines Agency recommend
1. Clinical measures: visual acuity, contrast sen- the use of MIDs as a method of evaluating effec-
sitivity, and visual field tiveness of new treatments [28].
2. Self-reported measurements of subjective

well-being
3. Performance-based assessments of the ability 21.3.2 Visual Activities
to carry out daily activities Questionnaire (VAQ)

A myriad of tests are used to assess quality of Visual Activities Questionnaire (VAQ) evalu-
life, and we summarize the most used and vali- ates patients’ perceptions of their visual func-
dated ones. tion. Patients answer to a five-point scale from
“never” to “always” if they had experienced one
of the eight subscale symptoms: glare disability,
21.3 T
 he National Eye Institute light/dark adaptation, acuity/spatial vision, visual
Visual Function search, visual processing speed, depth perception,
Questionnaire-25 (NEI color discrimination, and peripheral vision [20].
VFQ-25) As it includes a peripheral vision subscale,
the VAQ was included in the arsenal of QoL
The NEI VFQ-25 is widely used. It stands as a questionnaires used in the CIGTS.  Peripheral
benchmark for comparison with other special- vision subscale scores correlated more strongly
ized glaucoma QoL instruments [4], developed with visual field measurements, while overall
as a mechanism to evaluate vision problems VAQ scores correlated equally well with visual
though not focused on a specific condition and field and visual acuity measurements [20]. The
designed as a shorter version (compared to the VAQ peripheral vision subscale scores had the
51- and 96-item versions) but yet reliable, and strongest association with stratified categories of
validated form of capturing visual problems on visual field scores out of all the tests used in the
physical functioning, emotional well-being, and CIGTS [20].
social functioning. Disadvantages are that it is a Symptom and Health Problem Checklist has
test designed for advanced pathology and might 43 symptoms related to the disease process or
not be accurate for early-stage disease [25]. side effects of treatment. Symptoms have sub-
Compared to the normal control subjects, scales: visual function, 11 points; local eye, 7
glaucoma patients scored significantly lower, points; systemic, 20 points; and psychological,
including difficulty in driving and role limita- 5 points. For each symptom patients describe if
tions because of poor vision. Significant visual they have experienced it in the past 7 days, if it
field loss in the better eye correlated with poorer was related to the glaucoma treatment (entirely,
scores [26]. partially, or not at all), and how bothersome the
symptoms were (from “a lot” to “not at all” in a
five-point scale) [20].
21.3.1 Minimal Important Difference It is important, however, to evaluate the results
(MID) with care, and most of these tests or important
aspects of them are fairly subjective. People with
Minimal important difference (MID) can be different levels of visual functioning may have the
defined as the smallest difference in score in the same vision-specific quality-of-life score [29, 30].
21  Quality of Life Following Glaucoma Drainage Device Surgery 151

21.4 Q
 uality of Life in Glaucoma ception, bumping into objects and tripping, activi-
Patients ties given up because of vision limitation, finding
dropped objects, problems with glare/brightness,
Vision-specific instruments have greater ability and transition to darkness is not yet validated
to discriminate between glaucoma patients and formally, although objective correlations with
normal subjects. They also correlate loss of visual patients with glaucoma were found [33].
field better when comparing both groups than the
general health-related QoL instruments [4].
Glaucoma specific quality of life instruments 21.4.3 The Symptom Impact Glaucoma
have three general types of questions: one direct (SIG) and Glaucoma Health
question regarding visual ability (e.g., “Have you Perceptions Index (GHPI)
noticed a decrease in your peripheral vision?”
or “Do you have difficulty adjusting to a dark Both questionnaires developed for the CIGTS.
room?”), another aimed at task performance The SIG has a total of 43 items covering four
evaluation (e.g., “Does glaucoma limit your driv- subscales: visual ability, local eye, systemic, and
ing?” and “Do you have difficulties with house- psychological [20]. The GHPI covers six items
hold chores because of glaucoma?”), and a third looking into the impact of the disease on physical,
one evaluating the importance of losing that emotional, social, and cognitive components of
given task performance and visual ability to the health, glaucoma-­related stress, and concern about
patient [4]. going blind [20].
Tests that are used specifically for glaucoma
are:
21.4.4 The Glaucoma Quality of Life
(GQL)-15 Questionnaire
21.4.1 The GSS
This questionnaire brings together the most often
It is a ten-item checklist of symptoms common reported issues of daily living into four categories:
to glaucoma patients [31]. The symptomatic sub- outdoor mobility, glare/lighting conditions and
scale includes burning/stinging, tearing, dryness, activities that require peripheral vision, house-
itching, soreness/tiredness, and foreign body hold tasks, and personal care. Responses corre-
sensation. The visual ability subscale includes lated with visual field MD values, Pelli-­Robson
blurry/dim vision, difficulty seeing in daylight contrast sensitivity values, and the Esterman
and in darkness, and halos around lights. The visual field test scores [34]. Interestingly it found
patients are required to state how bothered they that decrease in visual ability was significantly
were by it. Glaucoma patients had significantly reported more by patients with mild visual field
lower scores on both subscales of the GSS, scor- loss when compared to normal patients, suggest-
ing worse on the visual ability subscale [31]. ing that glaucoma patients can distinguish even
Association between Esterman visual field and mild losses of visual field [34].
GSS scores was not significant. Contrast sensi- Medeiros et  al. established the association
tivity correlated with daylight vision [32]. between NEI VFQ-25 and standard automated
perimetry [3]. Subjects with a history of fast
visual field progression were more likely to report
21.4.2 The Questionnaire lesser QoL scores when compared to patients with
of Viswanathan a slow VF progression [25]. It is likely that in sub-
and Associates jects with slower VF progression, there would
be more time for development of compensatory
A ten-item questionnaire with a yes or no answer strategies that would reduce the impact of field
about visual field, deterioration in sight, color per- loss on QoL. In the univariable model, each 1 dB
152 B. de Padua Soares Bezerra et al.

of change in the binocular MS was associated unexpected given the creation of the bleb. Initially,
with an average change of 2.9 units in NEI VFQ- though, the CIGTS researchers hypothesized that
25 Rasch-calibrated scores. However, the amount the medication group would have worst scores
of baseline visual field (VF) change was also an given the local side effects of topical medica-
important factor influencing the impact of VF tion. Also, unlike patients who use medication for
change in QoL. More severe the baseline, greater a long time before having a surgical procedure,
the changes in the NEI VFQ-25 scores [3]. this cohort did not previously experience the side
The CIGTS approach to analyzing quality of effects of medical therapy and therefore could
life expected that symptomatic changes would have been more susceptible to changes and symp-
precede clinical changes. Symptom status and toms that arouse from their surgical treatment.
vision-related functioning would be followed by In summary, after 5  years of follow-up, the
more general health perceptions. The focus of impact reported in QoL for both groups was quite
that study was on symptom reporting and daily similar. The differences observed initially after
visual functioning based on the Visual Activities treatment diminished overtime. The worsening
Questionnaire and the Symptom and Health of clinical status was associated with change
Problem Checklist mainly [20]. in reported symptoms and perception of visual
VA changes have greater impact in quality of function.
life as measured by the VEI VFQ-25. The Tube vs. Trabeculectomy study is a multi-
Some visual field data is limited to the eye that center randomized clinical trial used to compare
had surgery performed on and therefore enrolled the safety and efficacy of the glaucoma drainage
in the study. It has been shown that binocular or device (GDD) and the conventional trabeculec-
better-eye visual status better predicts vision-­ tomy with mitomycin C (MMC) in patients with
specific quality of life [35, 36]. previous ocular surgery [41]. The GDD used in
Evidence shows that often self-reported mea- the study was the 350 mm2 Baerveldt glaucoma
sures do not correlate well with clinical measures implant (Abbott Medical Optics, Santa Ana,
of function [35–37], and individuals with simi- California, USA).
lar clinical status report different quality-of-life The quality-of-life outcomes between the two
experiences [38]. treatment groups were included as a secondary
outcome measure of this study. The MID in the
NEI VFQ-25 was calculated for these patients
21.5 Q
 uality of Life Following with advanced disease to assess clinical changes
Glaucoma Surgery overtime [18].
The TVT study found little difference in self-­
CIGTS showed worst quality-of-life scores in reported vision-specific quality of life between con-
surgical group compared with medical treatment ventional trabeculectomy and tube shunt surgery in
group. The surgical group performed worst in 5 years of follow-up. That suggests that patients are
three criteria: VAQ acuity, glaucoma local eye, likely to experience some sort of stability postop-
and glaucoma total score subscales, although eratively [18]. Similar findings were found in the
they had 0.1–2.5 differences in effect size when CIGTS with early glaucoma and patients who had
compared to baseline which represents a small either early surgery or eye drops found no differ-
clinical effect [20]. ence in the scores during the follow-up time [20].
Females and elderly population report more
problems with visual function-related activities
[39, 40]. 21.6 Conclusion
The frequency of bothersomeness evaluated
within the local eye subscale was greater since To date no significant vision-specific treatment
baseline and through the 4 years of follow-up in group differences have been detected in the RCTs
the surgically treated group, which does not seem that evaluated quality of life in glaucoma sur-
21  Quality of Life Following Glaucoma Drainage Device Surgery 153

gery or glaucoma drainage device implant. After culty recognizing faces? Invest Ophthalmol Vis Sci.
2012;53(7):3629–37.
5 years of follow-up in both studies, the impact 11. Kotecha A, O’Leary N, Melmoth D, Grant S, Crabb
observed is remarkably similar. Quality of life is DP.  The functional consequences of glaucoma for
mainly affected when visual acuity is affected. eye-hand coordination. Invest Ophthalmol Vis Sci.
However, there is limited data, and more studies 2009;50(1):203–13.
12. McGwin G Jr, Mays A, Joiner W, et al. Is glaucoma
are needed to establish the relationship properly. associated with motor vehicle collision involvement
Regarding the quality-of-life questionnaires and driving avoidance? Invest Ophthalmol Vis Sci.
and tests, they should ideally explore responses 2004;45(11):3934–9.
that will distinguish patients with glaucoma from 13. Altangerel U, Spaeth GL, Steinmann WC. Assessment
of function related to vision (AFREV). Ophthalmic
normal patients. They should also be able to cor- Epidemiol. 2006;13(1):67–80.
relate with performance-based measures of visual 14. Lorenzana L, Lankaranian D, Dugar J, et  al. A new
ability and clinical measures of disease progres- method of assessing ability to perform activities
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Ophthalmic Epidemiol. 2009;16(2):107–14.
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administration of the questionnaire. Relationships in glaucoma patients between stan-
dard vision tests, quality of life, and ability to
perform daily activities. Ophthalmic Epidemiol.
2010;17(3):144–51.
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Important Clinical Trials
in Glaucoma Drainage Devices 22
Monica Gandhi, Anupma Lal, and Shibal Bhartiya

22.1 Introduction The Ahmed glaucoma valve (AGV; New


World Medical, Ranchos Cucamonga, CA) is a
Trabeculectomy is considered as the gold stan- valved device with a tube, inserted in the anterior
dard filtering surgery for glaucoma. In recent chamber, leading to the end plate (184 mm2) to
times, there has been an increase in the number of which the aqueous is directed. The flow restrictor
glaucoma drainage devices (GDD) being decreases the aqueous flow when the intraocular
implanted for both primary and refractory glau- pressure is low. The Baerveldt glaucoma implant
comas [1–3]. (BGI; Abbott Medical Optics, Abbott Park, IL)
The decision to choose between trabeculec- has a larger end plate (350  mm2) and has no
tomy and GDD, and further which GDD to valve; therefore it tends to have a lower IOP fol-
implant, is often based on surgeons’ previous lowing the implantation and thus requires a liga-
experience, preference and skill, and the patients ture to moderate flow immediately after the
profile. surgery. Since the plate size of BGI is large, it
Randomised clinical trials (RCT) add to our requires implantation under the rectus muscles,
knowledge in making a systematically reviewed and the surgical procedure becomes longer/diffi-
rational choice. There are several studies done on cult [4].
various implants, but this chapter will focus on
the three main RCTs, namely, the Ahmed
Baerveldt Comparison (ABC) study, the Ahmed 22.2 The Tube Versus
Versus Baerveldt (AVB) study and the Tube Trabeculectomy (TVT) Study
Versus Trabeculectomy (TVT) study.
This was a prospective randomised multicentric
trial to compare the efficacy and safety of trab-
M. Gandhi (*) eculectomy with mitomycin C (MMC) and
Anterior Segment and Glaucoma Services, Baerveldt glaucoma implant (BGI) 350  mm2.
Department of Ophthalmology, Dr. Shroff’s Charity
Eye Hospital, New Delhi, India Two hundred and twelve patients between 18 and
85 years, with uncontrolled glaucoma (IOP ≥18
A. Lal
Lutheran Hospital, Fort Wayne, IN, USA and ≤40  mmHg on maximal tolerated medical
therapy) and previous failed filtering surgery and/
S. Bhartiya
Department of Ophthalmology, Fortis Memorial or cataract extraction with intraocular lens
Research Institute, Gurgaon, India implantation, were included [5].

© Springer Nature Singapore Pte Ltd. 2019 155


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_22
156 M. Gandhi et al.

The following patients were not included [5]: Both trabeculectomy with MMC (n 105) and
the BGI (n 107) produced a sustained, significant
• No light perception vision and comparable IOP reduction (p 0.097). At
• Pregnant or nursing women 5-year follow-up, the IOP (mean  ±  SD) was
• Active iris neovascularization 14.4  ±  6.9  mmHg in the tube group and
• Proliferative retinopathy 12.6 ± 5.9 mmHg in the trabeculectomy group (p
• Iridocorneal endothelial syndrome 0.12, 95% confidence interval −0.5  mmHg to
• Epithelial or fibrous downgrowth 4.1 mmHg).
• Aphasia The decrease in the number of glaucoma med-
• Vitreous in the anterior chamber for which a ications from baseline was 1.8 ± 1.8 in the tube
vitrectomy was anticipated group and 1.7 ± 2.0 in trabeculectomy group.
• Chronic or recurrent uveitis Failure of treatment was documented in 33%
• Severe posterior blepharitis of tube and 50% of trabeculectomy group. At 5
• Unwillingness to discontinue contact lens use years, the cumulative probability of failure was
after surgery 46.9% in the trabeculectomy group and 29.8% in
• Previous cyclodestructive procedure the tube group. The reasons for failure were simi-
• Prior scleral buckling procedure lar in both groups, and inadequate IOP lowering
• Presence of silicone oil was the foremost cause of failure. Persistent
• Conjunctival scarring precluding a superior hypotony and higher number of repetitions were
trabeculectomy observed more commonly in the trabeculectomy
• Need for glaucoma surgery combined with group. Since it was not a masked study, a poten-
other ocular procedures tial surgeon bias is possible, but the coordinates
• Anticipated need for additional ocular surgery studied that such a difference was not present in
the patients who underwent reoperations.
Twenty-five percent of patients achieved com-
22.2.1 Definition of Failure plete and 42% had qualified success in the tube
group. Twenty-nine and 21% of patients achieved
IOP >21 and ≤5  mmHg or less than 20%  IOP complete and qualified success, respectively, in
reduction from baseline as measured on two con- the trabeculectomy group. Thus, the rates of
secutive visits after 3 months was considered as complete success were comparable between the
criteria for failure. Also included were reopera- two groups with an overall higher rate of success
tions or loss of light perception. This is similar to in the BGI group.
the ABC study but differed from the AVB study
in terms of the target IOP.
22.3 Ahmed Baerveldt
Comparison (ABC) Study
22.2.2 Definition of Success
The ABC study was a multicentric randomised
The eyes that achieved the target IOP without controlled clinical trial which compared the long-­
additional glaucoma medication were considered term success, outcomes and complications of the
complete success, and those that required therapy two glaucoma drainage devices—the Ahmed
were classified as qualified success. glaucoma valve (AGV) and the Baerveldt glau-
coma implant (BGI).
Two hundred and seventy-six patients enrolled
22.2.3 Results of the TVT Study [6, 7] in 16 centres were randomised to either of the
implants and were followed up for 5  years,
For the analysis, patients who underwent addi- thereby yielding prospective data comparing the
tional glaucoma surgeries were excluded. devices in the control of glaucoma [8].
22  Important Clinical Trials in Glaucoma Drainage Devices 157

One hundred and forty-three underwent surgi- 22.3.2 Potential for Bias


cal implantation of the AGV implant, and 133 of
the Baerveldt implant amongst the patients It was an unmasked study with the decision to
enrolled between 2006 and 2008. Fifty-two per- reoperate based on the treating surgeon.
cent were males, and the mean age  ±  standard The surgeons in the ABC study indicated that
deviation of age was 63  ±  14  years. The mean they had performed more than 20 GDD implan-
baseline IOP was 31.5 ± 11.8 mmHg. The only tations. Those reporting to have done less than
difference in the baseline demographics was the five were included after screening of their surgi-
higher prevalence of hypertension in the AGV cal videos. This led to a small effect on the rate
group (13%). of complications reported  by the sur-
Inclusion criteria [8]: patients 18–85 years of geons  with  different levels of experience.
age with uncontrolled glaucoma Analysis of results at end of 1 year, showed that
(IOP > 18 mmHg) on maximal tolerated medical experienced surgeons had 20% less likelihood of
management and planned for GDD. complications in the AGV  implantation and
The patients were randomised between the 30%  less likelihood if they were skilled to
two implants; however, they were first stratified implant BGI [10].
into four groups depending on the diagnosis:

1. Primary glaucomas with previous intraocular 22.3.3 At 1-Year Follow-Up [10]
surgery
2. Secondary glaucomas (excluding neovascular The cumulative probability of failure was 16.4%
and uveitic glaucomas) (standard error [SE], 3.1%) in the AGV group
3. Neovascular glaucoma and 14.0% (SE, 3.1%) in the BGI group at 1 year
4. Uveitic glaucoma (p 0.52).
More patients experienced early postopera-
Neither the subject nor the investigator was tive complications in the BGI group (n 77;
masked to the randomisation. 58%) compared to the AGV group (n 61; 43%;
The surgical procedure was allowed to be p 0.016). Serious postoperative complications
according to the surgeons’ skill, but certain steps associated with reoperation (8% of AGV and
were standardised to bring uniformity. These 1% of BGI group), vision loss of two Snellen
included the use of FP7 AGV and 101-350 BGI lines (30% of AGV and 34% of BGI group), or
to be placed in the superotemporal quadrant, both in 29 patients (20%) in the AGV group
8–10 mm posterior to the limbus. and in 45 patients (34%) in the BGI group (p
The placement of the BGI under or over the 0.014).
superior and lateral rectus and the type of occlu- The most frequent causes of decrease in vision
sion of its tube were left to the surgeons’ at 1  year were glaucoma, macular disease and
discretion. cataract. The vision loss was higher in the patients
of neovascular glaucoma stratum and those who
had a better preoperative visual acuity.
22.3.1 Definition of Failure Postoperative interventions were more in the
BGI group (11% versus 6%) but were not statisti-
Failure was defined as IOP more than 21 mmHg cally significant (p = 0.077).
or less than 5 mmHg [9]. Other indicators were if Thus at 1  year  follow up, the IOP lowering
the IOP was not reduced by 20% compared to the was better, and lesser reoperations were needed
baseline and if the subject required additional for elevated IOP in the BGI group, but this came
glaucoma surgery or removal of the implant. at a price of more serious complications than the
Loss of light perception vision was also an indi- AGV group. If the efficacy and complications are
cator of failure. taken together, the study does not prove one
158 M. Gandhi et al.

implant to be clearly superior than the other. And 22.4 T


 he Ahmed Versus Baerveldt
since the significance level of the study was set at (AVB) Study
0.05, there is a probability that the results
occurred by chance alone [10]. The AVB study was a prospective randomised
The results at the end of 5-year follow-up are multicentric clinical trial including 238 patients.
depicted in Table 22.1. They are compared with Ten surgeons from seven clinical centres
the results of the AVB study. implanted the AGV FP 7 and the BGI 350 mm2

Table 22.1  Comparison of parameters between ABC and AVB study


AT 5 years AGV BGI p value
Number of patients (at the ABC study 143 133 63% completed
beginning of the study) the 5-year
follow-up
AVB study 124 114 72% completed
the 5-year
follow-up
IOP (mean ± SD) (mmHg) ABC study 14.7 ± 4.4 12.7 ± 4.5 0.015
AVB study 16.6 ± 5.9 13.6 ± 5.0 0.001
No. of glaucoma ABC study 2.2 ± 1.4 1.8 ± 1.5 0.28
medications in use
AVB study 1.8 ± 1.5 1.2 ± 1.3 0.03
Cumulative probability of ABC study 44.7% 39.4% 0.65
failure during 5 years of
follow-up
AVB study 53% 40% 0.04
No. of subjects failing ABC study 46 (80% of AGV 25 (53% of BGI 0.003
because of inadequate IOP failures) failures)
or reoperation
AVB study 45% failed due to high 23% failed due to high
IOP. 0% due to IOP 4% due to
hypotony hypotony
15% required de novo 10% required de novo
glaucoma surgery glaucoma surgery
Eyes with vision-threatening ABC study 11 (20% of AGV 22 (47% of BGI
complications failures) failures)
AVB study 6% 8%
Change in logarithm of ABC study 0.42 ± 0.99 0.43 ± 0.84 0.97
minimum angle of resolution
visual acuity
AVB study
Complete success (IOP ABC study 8% 14%
control without medication)
AVB study 2% complete success 4% complete success 0.49 (complete
12% qualified success 19% qualified success success)
0.12 (qualified
success)
22  Important Clinical Trials in Glaucoma Drainage Devices 159

depending on the randomisation. The patients in considered, the rates were high in both the groups
both groups were matched in their demographic (49% Ahmed, 37% Baerveldt, p 0.15).
and ocular characteristics except that there was a The risk factors for failure were male sex, lesser
greater proportion of females in the BGI group. previous intraocular surgeries including no previous
The patients were older than 18 years and had trabeculectomy, lower IOP and the use of Ahmed
uncontrolled refractory glaucoma despite the valve, as documented in the univariate analysis.
conventional medical, laser or surgical treatment. Ahmed valve continued to be a factor in multivariate
Patients not eligible for trabeculectomy with analysis. At 5 years, apart from these factors, the uni-
antifibrotic agents were included, like active neo- variate analysis documented neovascular glaucoma
vascular glaucoma and patients with significant as the risk factor for failure; however, this was not
conjunctival scarring [11]. supported by the multivariate analysis [13, 14].
The other parameters are compared with those
of the ABC study in Table 22.1.
22.4.1 Definition of Failure

IOP higher than 18 mmHg or lower than 5 mmHg 22.5 C


 ritical evaluation of some
or less than 20%  IOP reduction from baseline aspects of the RCTs
was included in the definition of failure. This was
recorded at two consecutive visits at or after 22.5.1 Data Censoring
3 months.
If the patients required additional glaucoma In ABC and AVB studies, subjects who underwent
surgery or needed device explantation, it was con- reoperations, explanation of implants and had loss
sidered a failure along with if there was  loss of of light perception were excluded from the sec-
light perception and associated vision-­threatening ondary analyses. 43 subjects in the AVB  study
complications. In ABC study the range of accept- were excluded based on these criteria (20% of
able IOP was >5 and <21 mmHg [8]. Ahmed and 16% Baerveldt group). However, the
Complete success was defined as patients who visual acuity, complications and interventions per-
maintained the IOP in the desired levels without taining to the original surgery were included in the
medication and did not require additional surgi- AVB study and not in the ABC study analysis. The
cal interventions, and their visual loss did not visual outcome of patients who were eviscerated
exceed doubling of the baseline LogMAR, at all was also carried forward for analysis.
visits after 3 months [9].

22.5.2 What was the Failure Rate at


22.4.2 Results at 1 Year [12] 5 Years in Both Groups of ABC
Study?
At the end of 1 year, 90% of patients completed
the follow-up. Eight percent of the Ahmed group The cumulative failure rate at 5 years was approxi-
and 17% of the Baerveldt group reported com- mately 40% in both groups [15]. The reason for
plete success (p 0.020), and cumulative probabil- failure, however, was different in the groups. AGV
ity of failure was 43% in the AGV group and 28% group had higher IOP, and BGI had more compli-
in the BGI group (p 0.020). This was when IOP cations. The reason for this could be based on the
more than 18 mmHg was considered as the crite- fact that AGV has a smaller end plate, and being a
ria for failure. However, if IOP of more than valved implant, it starts draining immediately
21 mmHg was considered, as in the ABC study, post-op. This exposes the bleb to the cytokines,
the rates were 28% and 21%, respectively. If proteins and inflammatory cells of the aqueous
alternatively the target IOP of 14  mmHg was leading to fibrosis. The BGI, on the other hand, has
160 M. Gandhi et al.

a bigger end plate and no flow restrictor.  The 22.5.5 Are ABC and AVB Comparable
tube is ligated during the surgery, so the immediate Studies?
effect of these agents is minimised [16].
Another reason for increased tenon fibroblast The patient profile in both studies was similar
adhesion and fibrous encapsulation thereof with with mean preoperative IOP of 31.5  mmHg in
the Ahmed valve could be due to the greater ABC and 31.4 mmHg in AVB study. Average of
roughness of the implant material, as seen by glaucoma medication were 3.4 and 3.1, respec-
electron microscopy [17]. tively. The inclusion criteria were similar in both
studies, including advanced glaucoma cases
which had high risk of failure. The study designs
22.5.3 Does Size of End Plate Matter? were similar, but the definition of failure differed
as the IOP of >21 mmHg was considered in ABC
Logically the area of drainage should be directly and >18  mmHg in AVB study. The cumulative
proportional to the size of the end plate. Studies probability of failure at 5 years was comparable
done on the double- and single-plate Molteno when the IOP criteria were matched [22].
implants substantiate a higher success rate and Both studies concluded that the BGI leads to a
lower IOP with the former implant [18, 19]. greater long-term IOP control compared to the
Comparison of Baerveldt 500  mm2 with AGV. The two studies thus validate the findings
350  mm2 in a prospective clinical trial showed of each other due to similar results.
similar outcomes in the two different-sized end
plates [20]. Even the study conducted to evalu-
ate the difference between the Baerveldt 22.5.6 Can We Choose Between AGV
250 mm2 and 350 mm2 concluded that there is and BGI Based on the ABC
an upper limit of the end plate size which con- Study?
fers the benefit of lowering IOP proportionate to
the size [21]. The study suggests that with the BGI, a lower IOP
in the long term can be achieved and it may be
considered in patients where a lowest possible IOP
22.5.4 In The TVT Study, the is desired postoperatively. But if the safety and
Baerveldt Implant Showed a efficacy are considered, the study does not demon-
Complete Success of 25% Compared strate a clear choice between the two implants.
to 14% in the ABC Study. Why did They recommend the surgeon to choose based
that Happen? on the individual patient characteristics, and his
skill and experience with each implant. One can-
This was because of the patient selection [5, 8]. not disregard the complications possible with the
The ABC study included patients with secondary implants and the benefits based on the preopera-
glaucomas (post uveitis, neovascular glaucoma tive diagnosis.
and glaucoma with iridocorneal endothelial syn- The choice between the valved and non-valved
drome, etc.). These are associated with refractory would be based on the urgency to lower the IOP,
glaucoma and poor prognosis. The TVT study again based on the patient characteristics.
did not include such patients; thus the rate of
complete success reported was higher.
The ABC study divided their subjects into 22.5.7 Can We Choose Between AGV
four strata, of which the first was similar to the and BGI Based on the AVB
subjects included in the TVT study. And in this Study?
stratum, the rate of complete success was 21%
which is similar to the 25% of the TVT study Baerveldt implant leads to an IOP 3 mmHg lower
[6, 7, 15]. than the Ahmed implant, and also the glaucoma
22  Important Clinical Trials in Glaucoma Drainage Devices 161

medication needed is a median of 1 compared to to techniques used by the surgeon as the proce-
2 in AGV at the end of 5 years. dure was not completely standardised.
The loss of two of more lines of vision was This study was focused on the two implants;
noted in 43% of the Ahmed group and 46% of the thus the results cannot be extrapolated to the
Baerveldt group. Both groups had high other designs and models. The results do not
postoperative complication rates, but most
­ apply to the diagnostic groups not included in the
required minimal interventions or were transient. study, namely, the subjects who have a low
The study coordinators recommend that when a risk for standard trabeculectomy.
low long-term IOP is desired and if patients are The analysis excluded patients if they required
intolerant to topical medications, Baerveldt implant a reoperation, explanation of implant or lost per-
is a good choice. However, postoperatively the ception of light.
patient may require a meticulous follow-­up to man-
age complications. In patients where immediate
lowering of IOP is required, Ahmed valve works 22.5.10  What Are the Limitations
best. This may, however, have to be substantiated of the AVB Study?
with medications and additional glaucoma surgery.
But it is also recommended that the final The patients at high risk of failure were recruited, so
choice be based on patient diagnosis and risk fac- the results cannot be applied to the patients in the
tors for failure, the IOP which will preserve optic early stages of the disease where the glaucoma
disc health, and the surgeons’ skill and familiar- drainage devices are being used more often now.
ity with the chosen implant. The definition of success was based on visual acuity
and not the sensitive predictors of optic nerve health
such as automated perimetry. But this would be true
22.5.8 Does TVT Help in Making for other studies too as the baseline vision of refrac-
a Choice Between Tube tory glaucoma patients is expected to be low.
and Trabeculectomy? The AVB study coordinators suggest that the
results of their study do not suggest supremacy of
The study demonstrates efficacy of both trabecu- any device and that a meticulous understanding
lectomy and tube in the subset of patients of the clinical stage of the patient and balancing
included but does not prove superiority of one it with the other criteria are required.
over the other. It supports the practice pattern
shift of greater tube shunt usage by glaucoma
surgeons based on the patient characteristics 22.5.11  What Are the Limitations
and the doctors' skill. It helps in choosing a tube of the TVT Study?
implant in a patient where a previous filtering
surgery has failed. The patient selection was very limited, and it did
not include patients with factors which increase
risk of failure. The results therefore, cannot be
22.5.9 What Are the Limitations extrapolated to the patients with characteristics
of the ABC Study? different from those included in this study.
It was an unmasked study with standardisation
It is not a masked study therefore, the surgeon of only a part of the surgeries, giving the sur-
bias could have played a role. The surgeons geons latitude to perform it according to their
enrolled to operate had experience with each type skill and comfort and also to decide on criteria
of implant, but those who had performed less for reoperations. The dose of MMC used was
than five surgeries were also included. It was higher (0.4  mg/ml for 4  min) than what is cur-
noted that the rate of complications was higher in rently used, and it could be a reason for hypotony
the latter group. There could also be variation due and rates of failure.
162 M. Gandhi et al.

22.6 Summary Association. Amsterdam, The Netherlands: Kugler;


2008. p. 15–24.
10. Budenz DL, Barton K, Feuer WJ, et  al., Ahmed

The RCTs help in making an informed choice of Baerveldt Comparison Study Group. Treatment
the surgical intervention for management of glau- outcomes in the Ahmed Baerveldt Comparison
coma. The studies do not give a clear superiority Study after 1 year of follow-up. Ophthalmology.
2011;118:443–452.
of any procedure and suggest that the final deci- 11. Christakis PG, Tsai JC, Zurakowski D, et  al. The
sion can be based on the patient characteristics Ahmed Versus Baerveldt study: design, baseline
and surgeons’ experience. patient characteristics, and intraoperative complica-
tions. Ophthalmology. 2011;118:2172–9.
12. Christakis PG, Kalenak JW, Zurakowski D, et al. The
Ahmed Versus Baerveldt study: one-year treatment
References outcomes. Ophthalmology. 2011;118:2180–9.
13. Christakis PG, Tsai JC, Kalenak JW, et al. The Ahmed
1. Ramulu PY, Corcoran KJ, Corcoran SL, Robin versus Baerveldt study: three-year treatment out-
AL.  Utilization of various glaucoma surgeries and comes. Ophthalmology. 2013;120:2232–40.
procedures in Medicare beneficiaries from 1995 to 14. Christakis PG, Kalenak JW, Tsai JC, Zurakowski D,
2004. Ophthalmology. 2007;114:2265–70. Kammer JA, Harasymowycz PJ, et  al. The Ahmed
2. Chen PP, Yamamoto T, Sawada A, et al. Use of anti- Versus Baerveldt Study: five-year treatment out-
fibrosis agents and glaucoma drainage devices in comes. Ophthalmology. 2016;123:2093–102.
the American and Japanese Glaucoma Societies. J 15. Budenz DL, Barton K, Gedde SJ, et  al. Five-year
Glaucoma. 1997;6:192–6. treatment outcomes in the Ahmed Baerveldt compari-
3. Desai MA, Gedde SJ, Feuer WJ, et al. Practice prefer- son study. Ophthalmology. 2015;122:308–16.
ences for glaucoma surgery: a survey of the American 16. Freedman J, Iserovich P. Pro-inflammatory cytokines
Glaucoma Society in 2008. Ophthalmic Surg Lasers in glaucomatous aqueous and encysted Molteno
Imaging. 2011;42:202–8. implant blebs and their relationship to pressure. Invest
4. Minckler DS, Francis BA, Hodapp EA, et al. Aqueous Ophthalmol Vis Sci. 2013;54:4851–5.
shunts in glaucoma: a report by the American 17. Choritz L, Koynov K, Renieri G, et al. Surface topog-
Academy of Ophthalmology. Ophthalmology. raphies of glaucoma drainage devices and their influ-
2008;115:1089–98. ence on human tenon fibroblast adhesion. Invest
5. Gedde SJ, Schiffman JC, Feuer WJ, et al. The Tube Ophthalmol Vis Sci. 2010;51:4047–53.
Versus Trabeculectomy Study: design and baseline 18. Heuer DK, Lloyd MA, Abrams DA, et  al. Which is
characteristics of study patients. Am J Ophthalmol. better? One or two? A randomized clinical trial of
2005;140(2):275–87. single-plate versus double-plate Molteno implanta-
6. Gedde SJ, Schiffman JC, Feuer WJ, et al. Tube Versus tion for glaucomas in aphakia and pseudophakia.
Trabeculectomy Study Group. Treatment outcomes Ophthalmology. 1992;99:1512–9.
in the Tube Versus Trabeculectomy (TVT) Study 19.
Molteno AC, Fucik M, Dempster AG, Bevin
after five years of follow-up. Am J Ophthalmol. TH. Otago Glaucoma Surgery Outcome Study: factors
2012;153:789–803. controlling capsule fibrosis around Molteno implants
7. Gedde SJ, Herndon LW, Brandt JD, et al. Postoperative with histopathological correlation. Ophthalmology.
complications in the Tube Versus Trabeculectomy 2003;110:2198–206.
(TVT) study during five years of follow-up. Am J 20. Britt MT, LaBree LD, Lloyd MA, et al. Randomized
Ophthalmol. 2012;153:804–814.e1. clinical trial of the 350-mm2 versus the 500-mm2
8. Barton K, Gedde SJ, Budenz DL, et  al. Ahmed Baerveldt implant: longer term results: is bigger bet-
Baerveldt Comparison Study Group. The Ahmed ter? Ophthalmology. 1999;106:2312–8.
Baerveldt Comparison Study: methodology, baseline 21. Seah SKL, Gazzard G, Aung T.  Intermediate-term
patient characteristics, and intraoperative complica- outcome of Baerveldt glaucoma implants in Asian
tions. Ophthalmology. 2011;118:435–442. eyes. Ophthalmology. 2003;110:888–94.
9. Heuer DK, Barton K, Grehn F, et  al. Consensus on 22. Christakis PG, Zhang D, Budenz DL, Barton K,

definitions of success. In: Shaarawy TM, Sherwood Tsai JC, Ahmed II, ABC-AVB Study Groups. Five-­
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Study. Am J Ophthalmol. 2017;176:118–26.
Newer Devices for Aqueous
Drainage 23
Reena Choudhry, Isha Vatsal, and Foram Desai

23.1 Introduction open-angle glaucoma and are generally per-


formed in combination with cataract extraction.
Glaucoma is the leading cause of irreversible This chapter aims to summarize the current
blindness worldwide [1, 2]. Though trabeculec- options for MIGS and provides an overview on
tomy still remains the “gold standard” in glau- their effectiveness and safety.
coma surgery, it is associated with significant
morbidity such as hypotony and bleb-related MIGS and Its Key Features
complications [3–5]. With this background, there • Ab interno approach with gonioscopic
has been a constant search for alternative proce- assistance
dures that are less invasive and safer, have opti- • Safer
mal IOP-lowering effect, and improve quality of • Minimally invasive
life in patients with chronic glaucoma. • Conjunctival sparing
The algorithm of glaucoma treatment, there- • Rapid recovery
fore, is experiencing a gradual shift from conven- • Largely bleb independent
tional trabeculectomy to minimally invasive
glaucoma surgery (MIGS). These procedures aim
at either overcoming the resistance at the juxta- Indications
canalicular meshwork, increasing uveoscleral • Primary open-angle glaucomas
outflow via suprachoroidal pathway, or creating a • Secondary open-angle glaucomas like pig-
subconjunctival drainage pathway [6]. mentary glaucoma, pseudoexfoliation
MIGS appears to provide a safer, less invasive glaucoma
means of reducing IOP than traditional trabecu- • Mild-to-moderate disease
lectomy in patients with glaucoma [2]. Currently, • Glaucoma with coexisting cataract
results suggest that these procedures tend to
achieve moderate IOP-lowering effect and are
ideal when a very low target IOP is not the Contraindications
requirement [1]. Typically, all the MIGS proce- • Primary and secondary angle-closure
dures are indicated in the eyes with primary glaucomas
• Advanced glaucomas
• Previous glaucoma surgery
R. Choudhry (*) · I. Vatsal · F. Desai • Need for low target IOP
ICARE Eye Hospital and Post Graduate Institute,
Noida, India

© Springer Nature Singapore Pte Ltd. 2019 163


M. Gandhi, S. Bhartiya (eds.), Glaucoma Drainage Devices,
https://doi.org/10.1007/978-981-13-5773-2_23
164 R. Choudhry et al.

23.1.1 Classification of MIGS canal (SC), thus reestablishing access to the eyes’
natural drainage system. It removes the area of
1. Procedures increasing trabecular outflow by greatest resistance to the aqueous outflow and
bypassing the juxtacanalicular trabecular can be performed simultaneously with cataract
meshwork (TM) surgery [7, 8].
• Trabectome
• iStent
• Hydrus 23.2.1 Design
• Excimer laser trabeculotomy (ELT)
• Gonioscopy-assisted transluminal Trabectome comes with a 19.5-gauge disposable
trabeculotomy(GATT) handpiece with an insulated footplate containing
2. Procedures increasing uveoscleral outflow via electrocautery, irrigation, and aspiration func-
suprachoroidal pathway tions (Fig. 23.1).
• CyPass Micro-Stent It creates a 200 μm plasma cloud between the
3. Subconjunctival drainage pathway rod and the outer electrode. Heat dissipation is
• XEN Gel Stent restricted by the outer footplate; thus, the heat
damage does not occur in the deeper parts of the
TM [9]. About 90°–120° area can be treated
23.2 Trabectome through a single incision.

Trabectome was approved by the US Food and


Drug Administration (FDA) and introduced in 23.2.2 Procedure
2004. It uses a high-frequency (550 kHz) bipolar
electrocautery to ablate a strip of trabecular A 2 mm flared clear corneal incision is made. The
meshwork (TM) and the inner wall of Schlemm’s anterior chamber is formed with saline.

a. Handpiece
b. Power, IA Line
c. Irrigation/Aspiration Unit b
d. High Frequency Generator
e. Clean Tray
Irrigation Port f. Main Control
g. Foot Control

a
c

Protective d
Footplate

Aspiration Part e
Retum Electrode
Active Electrode

Fig. 23.1 Trabectome
23  Newer Devices for Aqueous Drainage 165

Viscoelastic is not recommended for AC refor- group and from 2.6 to 1.5 in the combined group.
mation as it (1) creates a blur by forming optical A total of 14% (100 patients) were considered
interfaces, (2) makes it harder to induce hypotony to failure cases from Trabectome alone group.
visualize the Schlemm’s canal, and (3) traps plasma Robust data from well-designed randomized con-
gas bubbles, thus interfering with electrocautery. trolled trials are awaited.
Under direct gonioscopic visualization, the tip
is inserted in irrigation mode into the Schlemm’s
canal, and the electrocautery and aspiration are 23.3 Excimer Laser
activated by pressing the foot pedal. The TM is Trabeculotomy (ELT)
cauterized by advancing the tip in clockwise
direction followed by anticlockwise. In general, ELT (excimer laser trabeculotomy) is another
90°–120° is treated in a single sitting. Incision is form of ab interno trabeculotomy which uses
sutured to ensure water tight closure. 308  nm xenon chloride pulsed excimer laser to
create micro-perforations in the TM and inner
wall of Schlemm’s canal. It uses a photo-ablative
23.2.3 Key Advantages approach to vaporize the TM.

• Rapid recovery
• Can be performed with cataract surgery 23.3.1 Design
• No implant
• No antimetabolite The laser device comes in two forms. The first
device uses a gonioscopy lens to visualize the
TM, while the second device comes with an
23.2.4 Complications endoscopic laser probe for direct visualization.
Eight to ten laser burns are placed over 90°,
IOP spikes on first postoperative day and hyphema approximately 500  μm from one another. Each
are the most common complications. Iris and lens pulse delivers a mean energy of 1.2 mJ and is of
touch and goniosynechiae are other listed compli- 80 ns duration over a spot size of 200  μm.
cations [10]. Delayed-onset hyphema (2–30 months
following the procedure) has been reported and
attributed to Valsalva maneuver, the use of aspirin 23.3.2 Procedure
and warfarin, and IOP below episcleral venous
pressure [11]. A 1.2 mm corneal incision is made and viscoelas-
tic is injected into the AC. Laser probe is inserted
with its tip-up. When it is 2 mm away from the
23.2.5 Efficacy Data angle, place goniolens to visualize the TM. Laser
tip is contacted with TM, and 8–10 laser spots are
Minckler et  al. [12] examined the outcomes of placed over 90°. Micro-perforations and reflux of
Trabectome alone versus combined procedures blood are considered an end point of treatment.
with phacoemulsification based on data from
1127 surgeries performed at 46 study sites since
January 2006. At 24  months, IOP dropped by 23.3.3 Key Advantages
40% from 25.7  ±  7.7  mmHg preoperatively to
16.6 ± 4.0 mmHg in the Trabectome alone group • Rapid recovery
compared to 30% from 20.0  ±  6.2  mmHg to • Can be performed with cataract surgery
14.9  ±  3.1  mmHg in the combined phaco-­ • No implant
Trabectome group. Mean number of medications • No antimetabolite
decreased from 2.9 to 1.2  in the Trabectome • No interference with future surgeries
166 R. Choudhry et al.

23.3.4 Complications 23.4 iStent

Micro-bleeding can occur intraoperatively after The iStent (Glaukos Corporation, Laguna
the laser is applied and is usually transient. In the Hills, CA, USA) is a device designed to over-
available studies, no serious adverse events were come the outflow resistance at the trabecular
reported. level by creating a direct communication
between the anterior chamber and Schlemm’s
canal. iStent is a FDA-­ approved surgical
23.3.5 Efficacy Data implant and is indicated in patients with mild-
to-moderate open-angle glaucomas. The proce-
Babighian et al. in their prospective randomized dure can be done de novo or simultaneously
controlled 2-year study compared 180° of treat- with cataract surgery.
ment by ELT with selective laser trabeculoplasty
(SLT). Mean IOP reduction at 2 years was 29.6%
in the ELT group versus 21% in the SLT group. 23.4.1 Design
Glaucoma medications were reduced from
2.27 ± 0.7 to 0.87 ± 0.8 in the ELT group com- iStent is a heparin-coated, non-ferromagnetic
pared to a reduction from 2.20  ±  0.7 to implant made of surgical grade titanium. It is
0.87  ±  0.8  in the SLT group. Success rates, 1  mm in length and 0.3  mm in height, and the
defined by ≥20% IOP reduction without addi- lumen has a diameter of 120 μm; it has a ridged,
tional glaucoma intervention, were 53.3% for snorkel design with three retention arches on its
the ELT group compared to 40% for the SLT outer surface for secure placement (Fig. 23.2a).
group [13]. A second-generation model called the iStent

a b
Snorkel
0.3 mm
Ope
nH
alf P
ipe

Ret
enti
on A
Lumen 120 µm rche
s
Self-Trephining Tip
ACTUAL SIZE

Fig. 23.2 (a) Design of an iStent. (b) Picture showing the actual size of iStent. (c) iStent snorkel sits parallel to the iris
plane, and iStent rails are seated against scleral wall of Schlemm’s canal
23  Newer Devices for Aqueous Drainage 167

Fig. 23.3  Design of


iStent inject
Inlet orifice

Outflow
orifices
(4 total)

Flange Thorax Head


(resides in anterior chamber) (resides in (resides in Schlemm’s canal)
trabecular
meshwork)

inject (Fig.  23.3) has been available, and the 23.4.5 Efficacy Data
inserter comes preloaded with two stents allow-
ing the injection at the same time without exiting The US iStent Study Group performed a prospec-
the eye. tive randomized controlled multicenter clinical trial,
in which 240 eyes have mild-to-moderate glau-
coma. The eyes were randomized to iStent com-
23.4.2 Procedure bined with cataract surgery versus cataract surgery
alone. The percent IOP reduction was 8.0% with
The inserter is introduced through a 1.7 mm clear 87.0% medication reduction in the iStent-cataract
corneal incision under viscoelastic cover. The group at 12 months compared to 5.5% IOP reduc-
device is injected into the Schlemm’s canal under tion and 73.0% medication reduction in the cataract
gonioscopic view. The anterior chamber is group. At 1 year, 72% of the stent/CE/IOL group
cleared of the viscoelastic. had unmedicated IOP ≤21  mmHg, compared to
50% of CE/IOL-group eyes (P < 0.001) [15].

23.4.3 Key Advantages


23.5 S
 chlemm’s Canal Scaffold
• Rapid recovery (Hydrus)
• Can be performed with cataract surgery
• No antimetabolite Hydrus Microstent (Ivantis, Inc., Irvine, CA,
• No interference with future surgeries USA) is a canalicular implant that works on a
• Excellent safety profile similar principle of overcoming the trabecular
• Minimal risk of hypotony resistance to aqueous outflow. Furthermore, the
Hydrus dilates the Schlemm’s canal, and the
scaffold design helps to keep the collector chan-
23.4.4 Complications nel accessible, allowing greater flow of aqueous
from the anterior chamber. The rationale behind
IOP spike which is generally transient, intraop- dilating Schlemm’s canal lies in the previous
erative blood reflux from Schlemm’s canal, and findings that elevated IOP actually causes the
Stent malposition and obstruction are some of the canal to collapse, leading to lasting changes in
reported complications [14]. the TM and adjacent Schlemm’s canal [16].
168 R. Choudhry et al.

Fig. 23.4 (a) Design of


Hydrus implant. (b) Open posterior surface facing
Gonioscopic picture Schlemm’s Canal
showing Hydrus implant
in situ
a
Inlet facing the anterior chamber

Anterior surface with windows facing


trabecular meshwork

23.5.1 Design Schlemm’s canal, it dilates by four to five times


the natural width of the canal.
It is an 8-mm-long crescent-shaped implant made
of nitinol, a shape-memory alloy; it is curved to
match the shape of Schlemm’s canal and has a 23.5.3 Key Advantages
1 mm inlet portion which resides in the anterior
chamber (Fig. 23.4). • Rapid recovery
• Can be performed with cataract surgery
• No antimetabolite
23.5.2 Procedure • No interference with future surgeries

It is inserted under direct gonioscopic view


through a standard cataract corneal wound or it 23.5.4 Complications
can also be inserted through a 1–1.5 mm corneal
incision under viscoelastic cover. The device IOP spike which is generally transient, intraop-
spans to 3 clock hours, and once inserted into erative blood reflux from Schlemm’s canal, Stent
23  Newer Devices for Aqueous Drainage 169

malposition and obstruction, and focal peripheral surgery in patients with mild-to-­
moderate
anterior synechiae are some of the reported glaucoma.
complications.

23.6.1 Design
23.5.5 Efficacy Data
It is a 6.35 mm long flexible polyamide implant,
A 2-year randomized controlled single-masked with 510 μm of widest external diameter. Along
clinical trial results of the Hydrus Microstent with the distal end, the shaft has 64 micro holes
with concurrent cataract surgery compared to through which aqueous percolates into the supra-
cataract surgery alone reported that 80% of ciliary space. The proximal end has three reten-
Hydrus patients had a 20% reduction in washed-­ tion rings and a collar, which rests in the anterior
out IOP compared to 46% of patients undergoing chamber angle (Fig. 23.5).
cataract surgery alone (P = 0.0008). The IOP in
each group was 16.9 ± 3.3 mmHg in the Hydrus
group as compared to 19.2  ±  4.7  mmHg in the 23.6.2 Procedure
controls (P = 0.0093). No major adverse events
were reported [17]. It is inserted through clear corneal 1.5 mm inci-
sion under viscoelastic cover. CyPass implant is
threaded onto a retractable guide wire with non-­
23.6 Suprachoroidal Micro-Stent incisional tip. The guidewire is inserted into the
(CyPass) AC and is advanced to perform a blunt dissection
between sclera and ciliary body to create a plane.
CyPass Micro-Stent marketed by Alcon, a CyPass is then inserted into the plane, penetrat-
division of Novartis, is a flexible implant ing the distal end of the device into the supracho-
inserted into the supraciliary space from ante- roidal space, while the proximal collar remains in
rior chamber in conjunction with cataract sur- the anterior chamber. The retention rings are
gery, thus increasing the physiological engaged and viscoelastic removed. Implant posi-
uveoscleral outflow. It got the FDA approval tioning can be confirmed by postoperative goni-
in 2016 for use in combination with cataract oscopy and/or anterior segment OCT [18].

3 RETENTION RINGS: 64 FENESTRATIONS OUTER DIAMETER: INNER DIAMETER:


510 mm 430 mm 300 mm

6.35 mm

Fig. 23.5  CyPass Micro-Stent


170 R. Choudhry et al.

23.6.3 Key Advantages 23.7.1 Design

• Rapid recovery XEN/AqueSys implant is a soft tubular implant


• Can be performed with cataract surgery composed of porcine gelatin cross-linked with
• No antimetabolite glutaraldehyde. When hydrated, it becomes com-
• No interference with future surgeries pressible and tissue conforming. It is 6 mm long,
has width of a human hair, and comes in three
different lumen sizes of 45, 65, and 140 μm. The
23.6.4 Complications implant comes with an injector, preloaded within
a 27-gauge needle.
IOP spike in the early postoperative period is It is based on Poiseuille’s law of laminar flow.
generally transient. Early hypotony with or with- The length of the tube and inner diameter of the
out peripheral anterior choroidal effusion is tube determine the rate of flow.
reported. Intraoperative bleeding can occur in
some cases. Postoperative inflammation and
peripheral anterior synechiae have been reported 23.7.2 Procedure
[20]. Other complications included device mal-
position and movement and tube obstruction. A 2 mm clear corneal incision is made preferably
in the infero-nasal quadrant, so that the implant
can be placed in the supero-temporal quadrant.
23.6.5 Efficacy Data Anterior chamber is filled with viscoelastic.
Preloaded injector is introduced in the anterior
In a recent multicenter, single-arm interventional chamber and is advanced till it reaches the oppo-
study, García-Feijoo et al. reported the 1-year results site TM under direct gonioscopy. The needle is
of CyPass alone in 65 eyes with OAG. Baseline IOP inserted through the TM to create a scleral chan-
was reduced from 24.5 ± 2.8 mmHg with 2.2 ± 1.1 nel and is further advanced till the bevel of the
medications to 16.4  ±  5.5  mmHg with 1.4  ±  1.3 needle is seen in the subconjunctival space 3 mm
medications at 12 months. This was a 34.7% reduc- away from the limbus. Implant is then slowly
tion in IOP [19]. released in the subconjunctival space by pressing
Multicenter prospective series of 57 uncon- the injector, thus connecting the anterior chamber
trolled (≥21  mmHg) and 41 IOP-controlled to the subconjunctival space, forming a low-lying
(<21  mmHg) POAG patients by Hoeh et  al. ab interno bleb. Newer studies propose subcon-
reported 37% decrease in IOP and a 50% reduc- junctival mitomycin C use intraoperatively or
tion in glaucoma medications after CyPass postoperatively to reduce the subconjunctival
implantation combined with cataract surgery [20]. fibrosis (Fig. 23.6).

23.7 XEN Gel Stent/AqueSys 23.7.3 Key Advantages

Allergan received FDA approval for XEN Gel • Low-lying ab interno bleb formation
Stent (AqueSys) in November 2016 and is the • Controlled filtration reducing the incidence of
only device in MIGS category which creates a hypotony in comparison with trabeculectomy
bleb by allowing subconjunctival filtration of • Quick surgery with rapid recovery
aqueous like in trabeculectomy but in a con- • Can be performed with cataract surgery
trolled way. It is a gelatin stent that is implanted
into the subconjunctival space via a clear corneal
incision and without a conjunctival dissection, 23.7.4 Complications
thus creating a sclera tunnel connecting the ante-
rior chamber to the subconjunctival space where In cases where intraoperative subconjunctival
it forms an ab interno bleb [21]. bleeding occurs visualization of the implant
23  Newer Devices for Aqueous Drainage 171

improving the normal conventional outflow


pathway.

23.8.1 Procedure

Two clear corneal incisions are made.


Viscoelastic is injected into the anterior cham-
ber. Goniotomy is made in the nasal trabecular
meshwork under the guidance of a gonioscopy
Fig. 23.6 XEN gel implant connecting the anterior lens. With the help of microsurgical forceps, dis-
chamber to the subconjunctival space tal end of a 250  μm catheter/suture is advanced
into the Schlemm’s canal and then advanced cir-
becomes difficult. Minimal bleeding can occur in cumferentially for 360°, tracking its progress
most cases. IOP spike in early postoperative with its illuminated distal tip. Once the distal tip
period has been reported. Hypotony reported is has circumnavigated the entire canal, it is
usually short term. As the procedure leads to bleb retrieved and externalized. The leading tip is
formation, subconjunctival fibrosis can occur grasped with microsurgical forceps and pulled to
requiring needling with antimetabolites. Few the center of the anterior chamber. Gentle trac-
reports of internal ostium occlusion are also tion is applied to the externalized trailing end,
there. creating a constricting loop, which gradually
cleaves the entire TM, and, thus, creating a 360°
trabeculotomy ab interno. If cataract surgery is
23.7.5 Efficacy Data also planned, the GATT procedure is performed
first followed by cataract surgery [23].
There is very limited published data available on
the efficacy and safety of XEN Gel Stent. The
results of the AqueSys XEN 45 Glaucoma Implant 23.8.2 Key Advantages
in Refractory Glaucoma trial reported ≥25%
reduction in mean IOP in 80.8% of eyes at 1-year • 360° of angle is treated as opposed to smaller
follow-up, but 32.3% of eyes required needling portion by Trabectome, iStent, or conventional
with antimetabolites in the postoperative period. goniotomy.
A recent study documented complete success • Conjunctiva-sparing ab interno approach to
in 80.4% and a qualified success in 97.5% of trabeculotomy.
cases subjected to XEN stent implantation in • Can be considered in eyes with previous failed
conjunction with cataract surgery. In this study, blebs.
the mean preoperative IOP was 22.5 ± 3.7 mmHg • Can be performed with cataract surgery.
on 2.5  ±  0.9 medications. After 12  months, the
mean postoperative IOP was 13.1  ±  2.4  mmHg
(mean IOP reduction of 41.82%) with a mean of 23.8.3 Complications
0.4 ± 0.8 medications [22].
Most common complication of GATT is hyphema
which can be significant and can take up to
23.8 Gonioscopy-Assisted 1–2 weeks to clear, making the procedure contra-
Transluminal Trabeculotomy indicated in people with bleeding diathesis or
(GATT) unable to stop anticoagulation medications. IOP
spikes in early postoperative period can be seen.
GATT is a minimally invasive approach to a 360° There is also risk of endothelial damage as the
circumferential ab interno trabeculotomy [23]. It procedure requires significant manipulation in
cleaves the trabecular meshwork, thereby the anterior chamber.
172 R. Choudhry et al.

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