Manish Mahabir, Group 7 Silicone sling surgery for congenital ptosis: tarsal tunnel

technique vs. suture fixation

RATIONALE Commented [PHS IS1]: Manish: You have done a great job
in the rationale. This needs minimal work. Please see
comments below
Congenital ptosis with poor levator palpebrae superioris (LPS) action is a candidate for Commented [MM2R1]: Thanks
frontalis sling surgery, where the eyelid is elevated with the use of the frontalis muscle. Direct
connection between tarsus and frontalis muscle helps in mainly two ways. It provides suspension
to the eyelid in the primary position. In upgaze, some of the excursion of frontalis is transmitted
to tarsus and helps to elevate the eyelid. Among synthetic materials, silicone sling is mostly
preferred. We chose silicone sling because it can be passed easily through the proposed
technique of tarsal tunnel. It is stretchable and allows lid closure with minimal effort. There are
fewer chances of corneal exposure. Revision surgery if indicated is easy to perform. Silicone
sling has good biocompatibility. It takes less operating time and there is no donor site morbidity
(as compared to autogenous fascia lata). Low cost and easy availability is an added advantage. Commented [PHS IS3]: ? Easy access or availability of
care delivery?
Relatively high proportion of high-risk acquired blepharoptosis patients with minimal eyelid
excursion require revision. Silicone rod frontalis suspension surgery is preferred in these Commented [MM4R3]: Its easy availability of silicone sling
material, compared to its alternatives.
challenging cases for the ease of adjustment. Synthetic sling materials do not bio-integrate and
hence require anchoring with a strong structure i.e. tarsus. Recurrence and revision surgeries
required are mostly due to the migration of sling material (cheese-wiring) in the eyelid despite
suture fixation currently being practiced. Other causes promoting recurrence include loosening of
suture, rubbing of eyelids, loss of strength of sling material used, long-standing edema.
Modifications of frontalis sling technique have been proposed to maximize the frontalis muscle
action and to ensure the stability of correction over time eg. Triband Suspension - A modified
Garcias procedure. Authors used the 3-point fixation suspension technique that was similar to
that described first by Garcia and Blandford in 1959. Garcia claimed that it could prevent the Commented [PHS IS5]: Non-descriptive. Consider using
either name or guidelines...
notching and irregularities of the upper eyelid. Recurrence of ptosis following silicone sling
surgery varies from 7 to 44 percent. Various other complications that have been reported include Commented [MM6R5]: Used name

persistent lagophthalmos, exposure keratopathy, inflammation, infection, cellulitis, granuloma

formation, extrusion.

We are proposing tarsal tunnel modification to provide deeper, stronger and sutureless Commented [PHS IS7]: Please explain better. This will
need to have clear objectives.
anchoring to tarsus. Deeper fixation of silicone sling in tarsus is expected to be stronger and
will take care of cheese wiring in the eyelid. Hence, we expect low recurrence and reoperation Commented [MM8R7]: Changed better-> deeper, stronger
and sutureless
rate. Being a sutureless fixation to tarsus, there is no chance of erosion of overlying skin or
formation of suture granuloma. An important goal of ptosis surgery is symmetric and natural-
appearing cosmetic results. Tenting of pretarsal and preseptal skin, obliteration of eyelid crease,
and pulling away of the upper eyelid from the globe with brow elevation may all influence the
cosmetic outcome.(1) The superficial location of the sling in the eyelid may result in poor
outcome, and deeper placement of the sling in the tarsus as compared to superficial fixation on
tarsus may yield better cosmetic and functional results.(2)
Specific Aim 1: To evaluate the new technique of tarsal tunnel fixation in the correction of
congenital ptosis. Our technique is novel, but supported by literature as well as from our pilot
study. We expect that it will take care of severe ptosis.
Specific Aim 2: To compare the outcomes of tarsal tunnel technique with the method of suture
fixation in silicone sling surgery. Our technique has several advantages over conventional
technique. We expect it to have low recurrence and re-operation rate due to stronger anchorage
and better cosmesis due to deeper placement of sling material.
Commented [PHS IS9]: Further description will require a
clear hypothesis and assertive statement about the perform
work

1 19 Feb 17
 Manish Mahabir, Group 7 Silicone sling surgery for congenital ptosis: tarsal tunnel
technique vs. suture fixation

Commented [MM10R9]: Modified for clarity

BACKGROUND AND SIGNIFICANCE

Drooping of upper eyelid below the normal position (1-2 mm below superior limbus)
with the patient's head in fully upright position and eyes in primary gaze is called ptosis (from
the greek 'to fall'). The original classification of ptosis was between congenital and acquired.
With the understanding of pathological mechanism, the four categories are now: a) Myogenic, b)
Neurogenic, c) Aponeurotic, d) Mechanical.
Myogenic ptosis occurs when levator strength has diminished. Most common myogenic
ptosis is Simple congenital ptosis which can occur as an autosomal dominant with incomplete
penetrance or, more often, sporadically. Unilateral more often than bilateral. Simple congenital
ptosis is usually secondary to levator muscle maldevelopment. It neither contracts nor relaxes
properly. The frequency of levator maldevelopment ptosis compared to all forms of ptosis is
described as follows: Berke (88%), Smith (67%) and Beard (62%). It usually occurs sporadically
and unilaterally. Unilaterally has been quoted as 61% (Spaeth) and 75% (Beard)(36)

Timing of surgery

In congenital ptosis cases, it is recommended that surgery is deferred until the patient is at
least 3 to 5 years old, mainly to allow facial growth and maturation, as well as to ensure patient's
cooperation during preoperative evaluation and measurements. In addition, in some older
patients, surgery can be done under local anesthesia, which allows a better intra-operative
quantification and therefore a better surgical outcome.
About 20-70% of patients with simple congenital ptosis will develop amblyopia, and it is
more common in those with unilateral congenital ptosis. One of the causes of amblyopia is
astigmatism above 1.5 dioptres, which can be induced by pressure from the upper eyelid on the
cornea. Other causes of amblyopia include visual axis deprivation, anisometropia, or
convergence strabismus. In such patients, early surgical repair of congenital ptosis is required to
reduce the risk of amblyopia. In addition to the visual aspects mentioned, the sleepy appearance
in children with ptosis may have psychosocial aspects which warrant prompt surgical repair. In
patients with a recent neurogenic or traumatic ptosis, it is advised to wait at least 6 to 12 months
before a surgical intervention to allow spontaneous recovery or improvement of function.

Review of literature
Commented [PHS IS11]: I would avoid adding table and
incorporate this in the text. It seems that you are preparing for
Allen et al, 2012 evaluated outcomes of patients with oculopharyngeal muscular your publication but this is likely to represent an editorial
dystrophy (OPMD) with levator function (LF) 10mm who underwent primary bilateral silicone
frontalis suspension. Pre-operative measurements for MRD, PF and LF were - 0.050.82 mm
(OD), - 0.130.91 mm (OS); 5.21.2 mm (OD), 5.21.3 mm (OS); 11.61.3 mm (OD), and
11.71.3 mm (OS), respectively. Postoperative measurements for MRD and PF were 2.230.97
mm (OD), 2.101.09 mm (OS), 7.91.4 mm (OD), and 7.71.6 mm (OS), respectively (all
p<0.0001). The mean follow-up period was 22.822.4 months.(7) Sorge et al, 2012 evaluated
the incidence of exposure keratopathy following silicone frontalis suspension in adult neuro and
myogenic blepharoptosis. It was a retrospective noncomparative analysis of the charts of 69

2 19 Feb 17
 Manish Mahabir, Group 7 Silicone sling surgery for congenital ptosis: tarsal tunnel
technique vs. suture fixation

cases (101 eyelids) of silicone frontalis suspension. They used a closed method and did not use
suture to fix sling material to tarsus. Postoperative punctate epithelial erosions (PEE) were
encountered most frequently in patients with Steinerts disease (42% of eyes) and congenital
ptosis (33% of eyes). It was concluded that study cohort demonstrated a 26% risk of exposure
keratopathy following silicone frontalis suspension. The risk of major corneal complications,
such as ulceration, was low (3%). They found that revision requiring removal and replacement of
silicone sling was because of upward migration of the sling in the eyelid.(2) Rizvi et al, 2014
evaluated the efficacy and safety of silicone rod in tarsofrontalis sling surgery for severe
congenital ptosis. It was a prospective, case series study in 46 patients (56 eyelids) who
underwent tarsofrontalis sling surgery using silicone rod for severe congenital ptosis. The
efficacy of the silicone rod in tarsofrontalis sling surgery was evaluated by marginal reflex
distance1 (MRD1), postoperative eyelid symmetry, and recurrence of ptosis. Safety of silicone
rod was assessed by noting postoperative complications. In cases of unilateral congenital ptosis,
good results were seen in 83.3% cases, fair results in 11.1% cases, and poor results in 5.5%
cases. In cases of bilateral congenital ptosis, good results were seen in 80.0% cases, fair in 15.0%
cases, and poor result in 5.0% cases. Satisfactory postoperative eyelid elevation of 2 mm was
seen in 93% cases. Complications in the form of granuloma formation, subsequent silicone rod
extrusion, and recurrence occurred in 4% cases. It was concluded that the use of silicone rod in
tarsofrontalis sling surgery for severe congenital ptosis repair is a safe and effective surgery, with
few complications and easy removal and adjustment.(8)

PRELIMINARY DATA

In our unpublished pilot study at Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New
Delhi, India, with 24 patients with 12 in each group, Group 1: suture fixation group
(conventional technique) and Group 2: tarsal tunnel group (new technique) it was found that
baseline, as well as post-op outcomes in terms of vertical palpebral aperture in primary gaze and
residual ptosis, were comparable, with lagophthalmos being significantly less in tunnel group in
6 months of follow-up. Objective outcomes based on lid fold asymmetry and MRD1 asymmetry Commented [PHS IS12]: Is this published? Please provide
reference. If not please provide information about your
were comparable in both the groups. Subjective satisfaction level was found to be similar in both centre/hospital/institute.
the groups. It was concluded that the new technique of tarsal tunnel fixation is comparable to Commented [MM13R12]: Added centre as unpublished
the conventional technique of suture fixation in terms of complications, outcome and patient data
satisfaction in 6 months follow-up. It was recommended that tarsal tunnel technique is a safe and
effective procedure. But further studies with more number of subjects and a follow-up of longer
duration is required to provide conclusive results in terms of complication, cosmesis and
recurrence.

RESEARCH DESIGN AND METHODOLOGY Commented [PHS IS14]: You will need to add the
following:
1-Sample size calculation/ power analysis
Type of study: Prospective randomized controlled study 2- Statistical analysis plan
3- Statement regarding consenting the parents of the
Place: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi patients and Compliance with Ethical Standards
Plan of study: Two randomized groups of 60 patients to be taken up for tarsal tunnel technique Formatted: Highlight
and suture fixation technique (Assuming 1 baseline observation with 7 follow-up measurements, Commented [PHS IS15]: ? groups
effect size of 0.2, power of 80 percent, 5 percent alpha error, 2 sided test with 7 percent loss of Commented [MM16R15]: Group->groups
follow-up.), with a follow-up period of 3 years.

3 19 Feb 17
 Manish Mahabir, Group 7 Silicone sling surgery for congenital ptosis: tarsal tunnel
technique vs. suture fixation

Institutional ethics committee approval will be obtained before beginning the study. Study would
be conducted as per Indian Council of Medical Research Good Clinical Practice guidelines.
Written informed consent will be obtained in the vernacular language. If the participants are less
than 18 years of age, consent of the parents and assent of the participant will be taken. Analyses
of data from the baseline stage will include: description of demographics and baseline
characteristics of patients, laterality of prosis and prevalence of co-morbidities; Analyses of data
from the longitudinal follow-up will include: analysis of palpebral aperture, lagophthalmos and
recurrence of ptosis using survival analysis. Early and late complications in the two techniques
will be noted. Inclusion criteria: Simple severe congenital ptosis, LPS action 0-4 mm, Age > 3
years, willingness to participate in the study and give written informed consent. Exclusion
criteria: mild to moderate ptosis, complicated ptosis, post-traumatic ptosis, residual ptosis,
mechanical/ myogenic/ neurogenic ptosis, acquired senile ptosis, poor bells phenomenon,
corneal pathology, dry eye, unwilling to participate.

Surgical modification in proposed technique : In conventional technique, sling will be secured

to the tarsal plate using 3 non-absorbable 6-0 nylon sutures taking partial thickness bites in the
tarsus (Fig 1)(5). In our proposed modification, 3 vertical partial-thickness stab incisions will be
given sus 1-2 mm from its superior border, MVR blade will be used to make partial thickness
tunnel in sus connecting the incisions, silicone sling will be passed through the tunnel, making a
loop in ween which will be cut later (Fig 2). Eyelid will be everted to look for exposure of
silicone sling (to avoid granuloma formation or infection). Commented [PHS IS17]: Excellent work. Any reference for
this technique?
Commented [MM18R17]: Added
Schematic drawings

Fig 1: Three non-absorbable sutures to secure sling to Fig 2: In proposed technique Silicone sling will
tarsus in conventional technique be passed through the tunnel in tarsus Commented [PHS IS19]:
Commented [MM20R19]: Pictures are self-drawn
illustrations.

TIMELINE

Baseline data: History: Time of onset, Duration of onset, Course (stationary/ improving/
worsening), Diurnal variation, Degree of eye closure during sleep, H/o trauma, previous eye
surgery, change with jaw movement, strabismus, visual deficit, birth history, bleeding tendency,
drug allergy, family history. Examination: General physical examination, Ocular examination:
best corrected visual acuity using Snellens charts, ocular motility, cover test for squint, anterior
and posterior segment evaluation. Ptosis workup: Head position, facial asymmetry, frontalis
overaction, LPS action, margin reflex distance 1, amount of ptosis, lid crease, lid fold, lid lag,

4 19 Feb 17
 Manish Mahabir, Group 7 Silicone sling surgery for congenital ptosis: tarsal tunnel
technique vs. suture fixation

lagophthalmos, vertical palpebral aperture, bells phenomenon, Marcus Gunn jaw-winking

phenomenon, Schirmers test, tear film break-up time, entropion/ectropion.

Table1: Follow-up with subjective and objective assessment at the end of study.

Day 10 Month 1 Month 3 Month 6 Year 1 Year2 Year 3

Palpebral
aperture in
upgaze, primary
and downgaze
MRD1
Asymmetry
Lid lag
Lagophthalmos
Lid crease
Lid fold
Cornea
Bells
complication

Subjective assessment of patient satisfaction on a scale of 1-10. (Good: 8-10; fair: 5-7; poor:1-4)
Objective assessment of correction: For unilateral ptosis, the results will be considered good if
asymmetry between MRD1 for both eyelids is 1 mm, fair if the asymmetry is between 1.5 and 2
mm and poor if asymmetry >2 mm and/or there is an extrusion of the sling. For bilateral ptosis,
results will be considered good if MRD1 for both eyelids is 3 mm and eyelid asymmetry is 1
mm, fair if MRD1 is 2 or 2.5 mm for both eyelids and/or asymmetry is between 1.5 and 2 mm
and poor if MRD1 is <2 mm and/or asymmetry is >2 mm and/or there is extrusion of the sling
implant. Recurrence is defined as change of cosmesis from good/ fair to poor
Potential pitfalls and remedial strategies: Intraoperative: Tarsus perforation may be
encountered which can be managed by changing the plane of the tunnel intraoperatively.
Postoperative: Sling exposure or extrusion will need to undergo re-surgery. Lateral droop (?
Slippage of sling material) may be observed. Lid-notching gradually resolved on its own,
requires no surgery. Mild entropion is common in both the groups. Punctate corneal staining due
to exposure may be taken care of by frequent long-term lubricants and lubricating gel at bedtime.
There may be suture granuloma or corneal ulceration in severe cases. In the lower gaze, there
may be higher exposure of sclera as the upper lid is tethered to orbicularis by sling material. It
may be more cosmetically unacceptable in unilateral group. It requires pre-operative counseling.
In most of the studies, longer the duration of follow-up, higher the rate of recurrence have been
observed.

5 19 Feb 17
 Manish Mahabir, Group 7 Silicone sling surgery for congenital ptosis: tarsal tunnel
technique vs. suture fixation

REFERENCES Commented [PHS IS21]: Great work on references format.

Commented [MM22R21]: Thanks
1. Patrinely JR, Anderson RL. The septal pulley in frontalis suspension. Arch Ophthalmol.
1986 Nov;104(11):170710.

2. van Sorge AJ, Devogelaere T, Sotodeh M, Wubbels R, Paridaens D. Exposure keratopathy

following silicone frontalis suspension in adult neuro- and myogenic ptosis. Acta
Ophthalmol (Copenh). 2012 Mar;90(2):18892.

3. Berke RN, Wadsworth JA. Histology of levator muscle in congenital and acquired ptosis.
AMA Arch Ophthalmol. 1955 Mar;53(3):41328.

4. Rob CG, Smith R. Rob and Smiths Operative Surgery: Ophthalmic Surgery. Butterworths;
1984. 445 p.

5. Beard C. Ptosis. Mosby; 1981. 296 p.

6. Spaeth EB. An analysis of the causes, types, and factors important to the correction of
congenital blepharoptosis. Am J Ophthalmol. 1971 Mar;71(3):696717.

7. Allen RC, Zimmerman MB, Watterberg EA, Morrison LA, Carter KD. Primary bilateral
silicone frontalis suspension for good levator function ptosis in oculopharyngeal muscular
dystrophy. Br J Ophthalmol [Internet]. 2012 Apr 4 [cited 2012 Apr 22]; Available from:
http://bjo.bmj.com/cgi/doi/10.1136/bjophthalmol-2011-300667

8. Rizvi SAR, Gupta Y, Yousuf S. Evaluation of safety and efficacy of silicone rod in
tarsofrontalis sling surgery for severe congenital ptosis. Ophthal Plast Reconstr Surg. 2014
Feb;30(1):114.

6 19 Feb 17