Professional Documents
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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
This Springer imprint is published by the registered company Springer Nature Singapore Pte Ltd.
The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore
189721, Singapore
Preface
v
Contents
vii
viii Contents
ix
The Glaucoma Treatment
Paradigm: An Overview 1
Shibal Bhartiya, Parul Ichhpujani,
and Monica Gandhi
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
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.
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.
Fig. 2.1 A 24 year old female with chronic uveitis and multiple failed trabeculectomies and uncontrolled IOP
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
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
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
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
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
3.2.6 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?
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].
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
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
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].
• 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
14.
Ayyala RS, Harman LE, Michelini-Norris B, 27. Tarek S, Shibal B. Surgical management of glau-
et al. Comparison of different biomaterials for coma: evolving paradigms. Indian J Ophthalmol.
glaucoma drainage devices. Arch Ophthalmol. 2011;59(Suppl 1):S123–30.
1999;117:233–6. 28. Theime H. Current status of epibulbar anti-glaucoma
15. Ayyala RS, Michelini-Norris B, Flores A, et al.
drainage devices in Glaucoma surgery. Dtsch Arztebl
Comparison of different biomaterials for glau- Int. 2012;109(40):659–64.
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2000;118:1081–4. Rev Ophthalmol. 2009.
16.
Mackenzie PJ, Schertzer RM, Isbister 30. Ahmed IK, Christakis PG. Ahmed, Baerveldt or
CM. Comparison of silicone and polypropylene something else? Rev Ophthalmol. 2013.
Ahmed glaucoma valves: two-year follow-up. Can J 31. Kahook M, Shuman JS. Chandler and grant’s glau-
Ophthalmol. 2007;42:227–32. coma. 5th ed. Thorofare, NJ: Slack Inc.; 2013.
17. Brasil MVOM, Rockwood EJ, Smith S. Comparison p. 582–3.
of silicone and polypropylene Ahmed glaucoma valve 32. Yvonne O. Glaucoma surgery series: tube shunts—a
implants. J Glaucoma. 2007;16:36–41. new drainage device for glaucoma. 2014.
18. Ishida K, Netland PA, Costa VP, et al. Comparison of 33. David R. Does it matter which glaucoma drainage
polypropylene and silicone Ahmed glaucoma valves. device is implanted? 2014.
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
implant versus Ahmed valve for refractory glau- relevance to Sub-Saharan Africa. Middle East Afr J
coma: a case-controlled comparison. J Glaucoma. Ophthalmol. 2013;20:126–30.
2004;13:38–45. 35. Richard Z, Angela G. An OD’s guide to Glaucoma
20. Wang JC, See JL, Chew PT. Experience with the surgery: some patients will opt for drainage implants
use of Baerveldt and Ahmed glaucoma drainage or other procedures. How will they impact how
implants in an Asian population. Ophthalmology. optometrists monitor and treat? Rev Optom. 2015.
2004;111:1383–8. 36. Catoira Boyle Y. Mini-shunts vs. traditional shunts
21. Tsai JC, Johnson CC, Kammer JA, et al. The Ahmed in practice which to use: when and why. Ophthalmol
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coma II: longer-term outcomes from a single surgeon. 37. Chen TC. Surgical techniques in ophthalmology
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JC, Kammer JA, Harasymowycz PJ, Ahmed II. The 38. Mayer HR, Lin JL. New technologies for treating
Ahmed Versus Baerveldt study: one-year treatment Glaucoma in patients undergoing cataract surgery.
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40. Angmo D, Temkar S, Saini M, Aggarwal R, Dada
J, Costa VP, Godfrey DG, Buys YM, Ahmed T. The Ex-PRESS Glaucoma drainage device: current
Baerveldt Comparison Study Group. Treatment perspective. DJO. 2014;24:151–9.
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Study after 1 year of follow-up. Ophthalmology. devices, glaucoma–basic and clinical concepts. In:
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Surgical Technique
of Implantation: AGV, Limbal 6
Variant
Shibal Bhartiya and Monica Gandhi
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
6.5 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].
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
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.
Fig. 7.1 The device—Ahmed Glaucoma Valve with Pars plana clip—Adult and Pediatric valves
a b
Fig. 7.4 (a, b) Anterior segment photograph after pars plana 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.
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
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
Anterior
aperture
Anterior chamber
Tube
Posterior
aperture
Securing
suture
holes
Tube
plate
Superior
rectus
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
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
Suture hole
Translimbal tube
60 P. R. Shah et al.
Diathermy
Paracentesis
Insert tube
Relieving incisions *
Fig. 9.2 Flowchart summarising the surgical steps in the insertion of a Molteno implant
62 P. R. Shah et al.
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
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
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
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
• 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
Though they are associated with complications, 14. Harissi-Dagher M, Beyer J, Dohlman CH. The role of
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.
IOP and hence preserve vision. More research is 15. Netland PA, Terada H, Dohlman CH. Glaucoma
needed to compare and evaluate the safety and effi- associated with keratoprosthesis. Ophthalmology.
cacy of these implants in the long-term follow-up. 1998;105:751–7.
16. Chew HF, Ayres BD, Hammersmith KM, Rapuano CJ,
Laibson PR, Myers JS, et al. Boston keratoprosthesis
outcomes and complications. Cornea. 2009;28:989–96.
17. Birnbach CD, Leen MM. Digital palpation of intraocu-
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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
ing indications. Ophthalmology. 2009;116:640–51. C. Outcomes of Ahmed valve implant following a
12. Zerbe BL, Belin MW, Ciolino JB. Results from the failed initial trabeculotomy and trabeculectomy in
multicenter Boston Type 1 Keratoprosthesis Study. refractory primary congenital glaucoma. Middle East
Ophthalmology. 2006;113:1779 e1771–7. Afr J Ophthalmol. 2015;22(1):64–8.
13. Khan BF, Harissi-Dagher M, Khan DM, Dohlman 31. Budenz DL, Gedde SJ, Brandt JD, Kira D, Feuer
CH. Advances in Boston keratoprosthesis: enhancing W, Larson E. Baerveldt glaucoma implant in the
retention and prevention of infection and inflamma- management of refractory childhood glaucomas.
tion. Int Ophthalmol Clin. 2007;47:61–71. Ophthalmology. 2004;111:2204–10.
Combined Surgeries: Glaucoma
Drainage Devices and Cataract 12
Sagarika Patyal, Santosh Kumar,
and Suneeta Dubey
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].
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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López-Solís R, Traipe L. Combined phacoemulsifica- Chen PP. Combined Ahmed Glaucoma Valve place-
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Brandt JD, Budenz DL. Tube versus trabeculec- lectomy. J Curr Glaucoma Pract. 2015;9(1):6–11.
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Glaucoma Drainage Devices
(Ahmed Glaucoma Valve) 13
in Penetrating Keratoplasty-
Associated Glaucoma
Madhu 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
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.
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
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.
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).
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21. Dohlman CH, Grosskreutz CL, Dudenhoefer EJ, et al. 29. Ainsworth G, Rotchford A, Dua HS, King AJ. A novel
Can a glaucoma shunt tube be safely extended to the use of amniotic membrane in the management of tube
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patients? Dig J Ophthalmol 2002;7:3. Ophthalmol. 2006;90(4):417–9.
22. Dohlman CH, Grosskreutz CL, Dudenhoefer EJ,
30. Kalenak JW. Revision for exposed anterior segment
et al. Connecting Ahmed valve shunt to the lacrimal tubes. J Glaucoma. 2010;19(1):5–10.
sac or nasal sinuses in severe glaucoma. Am Acad 31. Rootman DB, Trope GF, Rootman DS. Glaucoma
Ophthalmol. Poster; 2002. aqueous drainage device erosion repair with
23. Dohlman CH, Barnes SD, Ma JJK, et al. Diverting buccal mucous membrane grafts. J Glaucoma.
aqueous humor to distant sites in severe glaucoma: an 2009;18(8):618–22.
update. Invest Ophthalmol Vis Sci. Poster; 2004. 32. Rosentreter A, Schild AM, Dinslage S, Dietlein
24. Li JY, Greiner MA, Brandt JD, et al. Long-term com- TS. Biodegradable implant for tissue repair after
plications associated with glaucoma drainage devices glaucoma drainage device surgery. J Glaucoma.
and Boston keratoprosthesis. Am J Ophthalmol. 2012;21(2):76–8.
2011;152:209–18. 33.
Grover DS, Merritt J, Godfrey DG, Fellman
25. Dohlman CH, Dudenhoefer EJ, Khan BF, et al.
RL. Forniceal Conjunctival Pedicle Flap for the
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2002;28:72–4. 662–6.
Glaucoma Drainage Devices
in Children 15
Oscar Daniel Albis-Donado
and Alejandra 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.
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
32. Mandalos A, Sung V. Glaucoma drainage device sur- 36. van Overdam KA, de Faber JT, Lemij HG, de Waard
gery in children and adults: a comparative study of PW. Baerveldt glaucoma implant in paediatric
outcomes and complications. Graefes Arch Clin Exp patients. Br J Ophthalmol. 2006;90(3):328–32.
Ophthalmol. 2017;255(5):1003–11. 37. Zagora SL, Funnell CL, Martin FJ, Smith JE, Hing
33. Rolim de Moura C, Fraser-Bell S, Stout A, Labree L, S, Billson FA, Veillard AS, Jamieson RV, Grigg
Nilfors M, Varma R. Experience with the baerveldt JR. Primary congenital glaucoma outcomes: les-
glaucoma implant in the management of pediatric sons from 23 years of follow-up. Am J Ophthalmol.
glaucoma. Am J Ophthalmol. 2005;139(5):847–54. 2015;159(4):788–96.
34. Meyer AM, Rodgers CD, Zou B, Rosenberg NC,
38. Nolan KW, Lucas J, Abbasian J. The use of irradi-
Webel AD, Sherwood MB. Retrospective comparison ated corneal patch grafts in pediatric Ahmed drainage
of intermediate-term efficacy of 350 mm2 glaucoma implant surgery. J AAPOS. 2015;19(5):445–9.
drainage implants and medium-sized 230–250 mm2 39. Vinod K, Panarelli JF, Gentile RC, Sidoti PA. Long-
implants. J Curr Glaucoma Pract. 2017;11(1):8–15. term outcomes and complications of pars plana
35. Tai AX, Song JC. Surgical outcomes of Baerveldt Baerveldt implantation in children. J Glaucoma.
implants in pediatric glaucoma patients. J AAPOS. 2017;26(3):266–71.
2014;18(6):550–3.
Modifications of Surgical
Techniques in Glaucoma Drainage 16
Devices
Kleyton Barella and Vital Paulino Costa
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
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].
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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Glaucoma Drainage Devices:
Complications and Their 17
Management
Bhumika Sharma, Monica Gandhi,
Suneeta Dubey, and Usha Yadava
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
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
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.
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
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
Early Late
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)
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
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
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
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
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
(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].
[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.
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
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.
Savona, Italy: European Glaucoma Society Editrice
Dogma; 2003.
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39. Van Bergen T, Moons L, Vandewalle E, et al. 5-fluorouracil. Graefes Arch Clin Exp Ophthalmol.
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Economic Considerations
of Glaucoma Drainage Devices 20
Maneesh Singh and Arijit Mitra
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:
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.
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)
3. Gordon MO, Beiser JA, Brandt JD, et al. The Ocular 13. Desai MA, Gedde SJ, Feuer WJ. Practice prefer-
Hypertension Treatment Study: baseline factors that ences for glaucoma surgery: a survey of American
predict the onset of primary open angle glaucoma. Glaucoma Society in 2008. Ophthalmic Surg Lasers
Arch Ophthalmol. 2002;2120(6):714–20. Imaging. 2011;42(3):202–8.
4. Gedde SJ, Schiffman JC, Feuer WJ, et al. Treatment 14. Minckler DS, Francis BA, Hodapp EA, et al.
outcomes in the Tube Versus Trabeculectomy (TVT) Aqueous shunts in glaucoma. A report by American
study after five years of follow-up. Am J Ophthalmol. Academy of Ophthalmology. Ophthalmology.
2012;153(5):789–803. 2008;115(6):1089–98.
5. Gedde SJ, the Tube Versus Trabeculectomy Study 15. Tuulonen A. Economics of surgery worldwide. In:
Group. Results from the Tube Versus Trabeculectomy Shaarawy TM, Sherwood MB, editors. Glaucoma,
Study. Middle East Afr J Ophthalmol. vol. 2. Edinburgh: Saunders Elsevier; 2009. p. 3–11.
2009;16(3):107–11. 16. Lee P, Matchar DB. Economics of glaucoma care. In:
6. Tuulonen A. Economic considerations of the diag- Shaarawy TM, Sherwood MB, editors. Glaucoma,
nosis and management for glaucoma in developed vol. 1. Edinburgh: Saunders Elsevier; 2009. p. 25–32.
world. Curr Opin Ophthalmol. 2011;22:102–9. 17. Tuulonen A, Airaksinen PJ, Erola E, et al. The Finnish
7. Boeteng W. Economics of surgery worldwide. In: Evidence Based Guideline for glaucoma. Acta
Shaarawy TM, Sherwood MB, editors. Glaucoma, Ophthalmol Scand. 2003;81:3–18.
vol. 2. Edinburgh: Saunders Elsevier; 2009. p. 13–6. 18. Burr J, Azuara-Blanco A, Avenell A. Medical ver-
8. Lam BL, Zheng D, Davila EP, et al. Trends in glau- sus surgical intervention for open angle glaucoma.
coma medication expenditure. Medical expendi- Cochrane Database Syst Rev. 2005;(2):CD004399.
ture panel survey 2001–2006. Arch Ophthalmol. 19. Whittaker KW, Gillow JT, Cunliffe IA. Is the role of
2011;129:1345–50. trabeculectomy in glaucoma management changing?
9. Anand A, Negi S, Khokhar S, et al. Role of early trab- Eye. 2001;15:449–52.
eculectomy in primary open angle glaucoma in devel- 20. Rachmiel R, Trope GE, Chipman ML, et al. Laser
oping world. Eye. 2007;21:40–5. trabeculoplasty trends with introduction of new medi-
10. Tseng VL, Coleman AL, Chang MY, Caprioli
cal treatments and selective laser trabeculoplasty. J
J. Aqueous shunts for glaucoma. Cochrane Database Glaucoma. 2006;15:306–9.
Syst Rev. 2017;7:CD004918. 21. Ainsworth JR, Jay JL. Cost analysis of early trabecu-
11. American Academy of Ophthalmology Glaucoma
lectomy versus conventional management in primary
Panel. Preferred Practice Pattern Guidelines. Primary open angle glaucoma. Eye. 1991;5:322–8.
open angle glaucoma. San Francisco, CA: American 22. Kaplan R, Moraes CGD, Cioffi GA, et al. Comparative
Academy of Ophthalmology; 2010. www.aao.org/ cost effectiveness of the Baerveldt implant,
ppp. Trabeculectomy with mitomycin and medical treat-
12. Ramulu PY, Corcoran KJ, Corcoran SL, Robin
ment. JAMA Ophthalmol. 2015;133(5):560–7.
AL. Utilization of various glaucoma surgeries and 23. Kaushik S, Kataria P, Raj S, et al. Safety and effi-
procedures in medicare beneficiaries from 1995 to cacy of a low cost glaucoma drainage device for
2004. Ophthalmology. 2007;114(12):2265–70. refractory childhood glaucoma. Br J Ophthalmol.
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
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
sion. Reducing unnecessary questions lessens the of daily living: design, methods and baseline data.
Ophthalmic Epidemiol. 2009;16(2):107–14.
assessment fatigability and reduces the cost of 15. Richman J, Lorenzana LL, Lankaranian D, et al.
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
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
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.
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
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.
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.
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.
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
Outflow
orifices
(4 total)
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].
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].
6.35 mm
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
23.8.1 Procedure
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