Clinical trial NCT01532765: Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal
Official title: A Multicentre Randomized Clinical Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epiretinal Membrane
Keywords: Internal limiting membrane
Indocyanine green dye
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention)
timeFrame: Comparing change at 6 months following surgery and baseline
measure: Change from baseline in visual acuity at 6 months post-surgery (intervention)
timeFrame: Comparing change of visual acuity at 6 months following surgery and baseline
Secondary outcomes:
measure: Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention)
timeFrame: 1 month following surgery
measure: Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery
timeFrame: 12 months following surgery
measure: Change from baseline in visual acuity at 1 month post-surgery (intervention)
timeFrame: 1 month following surgery (intervention)
measure: Change from baseline in visual acuity at 3 months post-surgery (intervention)
timeFrame: 3 months following surgery (intervention)
measure: Change from baseline in visual acuity at 12 months post-surgery (intervention)
timeFrame: 12 months following surgery (intervention)
measure: Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 1 month post-surgery (intervention)
timeFrame: 1 month following surgery (intervention)
measure: Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 3 months post-surgery (intervention)
timeFrame: 3 months following surgery
measure: Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 6 months post-surgery (intervention)
timeFrame: 6 months following surgery
measure: Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 12 months post-surgery (intervention)
timeFrame: 12 months following surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
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