NCT01532765

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Epiretinal Membrane

Interventions

Type	Name	Description
PROCEDURE	Pars plana vitrectomy and epiretinal membrane peel	23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization
PROCEDURE	ILM 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
PROCEDURE	CE-IOL	Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-05-01
• Completion: 2017-03-22
• First posted: 2012-02-14
• Last updated: 2018-09-21

Locations

3 sites across 1 country: Canada