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

NCT01532765 | Terminated

• 1 other identifier: 422-2010
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

Conditions

Epiretinal Membrane

Keywords

Internal limiting membrane; Indocyanine green dye

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention)

  1 month following surgery

• 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 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)

Study Arms (4)

Epiretinal Membrane Surgery without ILM peel

ACTIVE COMPARATOR

Procedure: Pars plana vitrectomy and epiretinal membrane peel

Epiretinal Membrane Surgery with ILM peel (ICG assisted)

ACTIVE COMPARATOR

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

Procedure: Pars plana vitrectomy and epiretinal membrane peel; Procedure: CE-IOL

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

ACTIVE COMPARATOR

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

Interventions

Pars plana vitrectomy and epiretinal membrane peel PROCEDURE

23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization

Combined CE & IOL and ERM surgery with ILM peel (ICG assisted); Combined CE & IOL and ERM surgery without ILM peel; Epiretinal Membrane Surgery with ILM peel (ICG assisted); Epiretinal Membrane Surgery without ILM peel

ILM peel assisted by ICG PROCEDURE

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

Combined CE & IOL and ERM surgery with ILM peel (ICG assisted); Epiretinal Membrane Surgery with ILM peel (ICG assisted)

CE-IOL PROCEDURE

Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant

Combined CE & IOL and ERM surgery with ILM peel (ICG assisted); Combined CE & IOL and ERM surgery without ILM peel

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• ERM on clinical exam and/or macular OCT
• Visual acuity of 20/40 or worse (attributable to ERM)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (3)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (28)

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MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: February 14, 2012
• Study Start: September 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: March 22, 2017
• Last Updated: September 21, 2018

Record last verified: 2015-12

Locations

CA (3)