Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal

Sunnybrook Health Sciences Centre13 enrolled

Overview

Macular epiretinal membrane (ERM) is a semitranslucent, avascular, fibrocellular membrane on the inner surface along the internal limiting membrane (ILM) of the retina. ERM may cause symptomatic visual disturbances and vision loss. Since the 1970s, pars plana vitrectomy has been performed to remove the membranes with few complications, and surgical results are generally good. Recurrence rates of 5-16% have been reported. Recently, ILM peeling in ERM surgery have been popularized by a number of retrospective studies and one prospective case series to minimize the rate of ERM recurrences (16% recurrence in ERM surgery with ILM peel compares to 0% recurrence in ERM surgery without ILM peel). Surgical removal of the friable and transparent ILM is difficult and increases the risk of trauma to the retina. In addition, indocyanine green (ICG), a dye commonly used intra-operatively to enhance ILM visualization, is costly and has been shown to be toxic to the retina. The investigators study will be the first randomized-controlled multi-centred clinical trial to compare the outcomes of ERM surgery with and without ILM peeling. The results will help guide and standardize the surgical treatment of macular ERM; to minimize unnecessary surgical risks, as well as to help economize healthcare cost.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Epiretinal Membrane

Pars plana vitrectomy and epiretinal membrane peelPROCEDURE

23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization

ILM peel assisted by ICGPROCEDURE

Indocyanine green dye is prepared from 25mg powder vial from AKORN INC., 10 mL diluent provided in kit. This is further diluted to final concentration of 0.5mg/mL using 50% sterile dextrose solution

CE-IOLPROCEDURE

Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant

Outcomes

Primary Outcomes

Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention)

Time frame: Comparing change at 6 months following surgery and baseline

Change from baseline in visual acuity at 6 months post-surgery (intervention)

Time frame: Comparing change of visual acuity at 6 months following surgery and baseline

Secondary Outcomes

Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention)

Time frame: 1 month following surgery

Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery

Time frame: 12 months following surgery

Change from baseline in visual acuity at 1 month post-surgery (intervention)

Time frame: 1 month following surgery (intervention)

Change from baseline in visual acuity at 3 months post-surgery (intervention)

Time frame: 3 months following surgery (intervention)

Change from baseline in visual acuity at 12 months post-surgery (intervention)

Time frame: 12 months following surgery (intervention)

Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 1 month post-surgery (intervention)

Time frame: 1 month following surgery (intervention)

Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 3 months post-surgery (intervention)

Time frame: 3 months following surgery

Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 6 months post-surgery (intervention)

Time frame: 6 months following surgery

Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 12 months post-surgery (intervention)