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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre Randomized Clinical Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling

Conditions
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Epiretinal Membrane

Intervention / Treatment
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* Procedure: Pars plana vitrectomy and epiretinal membrane peel
* Procedure: ILM peel assisted by ICG
* Procedure: CE-IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older ERM on clinical exam and/or macular OCT Visual acuity of 20/40 or worse (attributable to ERM) Exclusion Criteria: Prior surgery for ERM in the study eye Macular edema secondary to arterial/venous occlusion(s) Central serous retinopathy Age related macular degeneration Diabetic cystoid macular edema Proliferative Diabetic Retinopathy Uveitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epiretinal Membrane Surgery without ILM peel<br> | Procedure: Pars plana vitrectomy and epiretinal membrane peel<br>* 23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization<br>|
| Active Comparator: Epiretinal Membrane Surgery with ILM peel (ICG assisted)<br> | Procedure: Pars plana vitrectomy and epiretinal membrane peel<br>* 23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization<br>Procedure: ILM peel assisted by ICG<br>* 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<br>|
| Active Comparator: Combined CE & IOL and ERM surgery without ILM peel<br> | Procedure: Pars plana vitrectomy and epiretinal membrane peel<br>* 23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization<br>Procedure: CE-IOL<br>* Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant<br>|
| Active Comparator: Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)<br> | Procedure: Pars plana vitrectomy and epiretinal membrane peel<br>* 23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization<br>Procedure: ILM peel assisted by ICG<br>* 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<br>Procedure: CE-IOL<br>* Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention) |  | Comparing change at 6 months following surgery and baseline | 
| Change from baseline in visual acuity at 6 months post-surgery (intervention) |  | Comparing change of visual acuity at 6 months following surgery and baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention) |  | 1 month following surgery | 
| Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery |  | 12 months following surgery | 
| Change from baseline in visual acuity at 1 month post-surgery (intervention) |  | 1 month following surgery (intervention) | 
| Change from baseline in visual acuity at 3 months post-surgery (intervention) |  | 3 months following surgery (intervention) | 
| Change from baseline in visual acuity at 12 months post-surgery (intervention) |  | 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) |  | 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) |  | 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) |  | 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) |  | 12 months following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internal limiting membrane, Indocyanine green dye