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

Not Applicable

Terminated

• Conditions: Epiretinal Membrane
• Interventions: Procedure: Pars plana vitrectomy and epiretinal membrane peel; Procedure: CE-IOL; Procedure: ILM peel assisted by ICG

• Registration Number: NCT01532765
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-14
• Primary Completion: 2015-05
• Status Verified: 2015-12
• Study Completion: 2017-03-22
• Last Update Submitted: 2018-09-19
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epiretinal Membrane Surgery without ILM peel	Pars plana vitrectomy and epiretinal membrane peel	-
Epiretinal Membrane Surgery with ILM peel (ICG assisted)	Pars plana vitrectomy and epiretinal membrane peel	-
Combined CE & IOL and ERM surgery without ILM peel	Pars plana vitrectomy and epiretinal membrane peel	-
Combined CE & IOL and ERM surgery without ILM peel	CE-IOL	-
Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)	ILM peel assisted by ICG	-
Epiretinal Membrane Surgery with ILM peel (ICG assisted)	ILM peel assisted by ICG	-
Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)	Pars plana vitrectomy and epiretinal membrane peel	-
Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)	CE-IOL	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in visual acuity at 6 months post-surgery (intervention)	Comparing change of visual acuity at 6 months following surgery and baseline
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

Secondary Outcome Measures

Name	Time	Method
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 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 macular thickness on optical coherence tomography at 12 months post-surgery	12 months following surgery
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 3 months post-surgery (intervention)	3 months following surgery
Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention)	1 month 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

Trial Locations

Locations (3)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada