Epiretinal Membrane
Conditions
Keywords
Internal limiting membrane, Indocyanine green dye
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.
Interventions
PROCEDUREPars plana vitrectomy and epiretinal membrane peel
23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization
PROCEDUREILM peel assisted by ICG
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
PROCEDURECE-IOL
Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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 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 |
| 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 |
Countries
Canada
Outcome results
None listed