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

Sunnybrook Health Sciences Centre

Status: Terminated

Conditions: Epiretinal Membrane

Treatments: Procedure: Pars plana vitrectomy and epiretinal membrane peel; Procedure: CE-IOL; Procedure: ILM peel assisted by ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT01532765

422-2010

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 4 patient groups

Epiretinal Membrane Surgery without ILM peel

Active Comparator group

Treatment:

Procedure: Pars plana vitrectomy and epiretinal membrane peel

Epiretinal Membrane Surgery with ILM peel (ICG assisted)

Active Comparator group

Treatment:

Procedure: Pars plana vitrectomy and epiretinal membrane peel

Procedure: ILM peel assisted by ICG

Combined CE & IOL and ERM surgery without ILM peel

Active Comparator group

Treatment:

Procedure: CE-IOL

Procedure: Pars plana vitrectomy and epiretinal membrane peel

Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)

Active Comparator group

Treatment:

Procedure: CE-IOL

Procedure: Pars plana vitrectomy and epiretinal membrane peel

Procedure: ILM peel assisted by ICG