Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Epiretinal Membrane |
Procedure: Pars plana vitrectomy and epiretinal membrane peel Procedure: ILM peel assisted by ICG Procedure: CE-IOL |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicentre Randomized Clinical Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling |
- Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention) [ Time Frame: Comparing change at 6 months following surgery and baseline ] [ Designated as safety issue: No ]
- Change from baseline in visual acuity at 6 months post-surgery (intervention) [ Time Frame: Comparing change of visual acuity at 6 months following surgery and baseline ] [ Designated as safety issue: No ]
- Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention) [ Time Frame: 1 month following surgery ] [ Designated as safety issue: No ]
- Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
- Change from baseline in visual acuity at 1 month post-surgery (intervention) [ Time Frame: 1 month following surgery (intervention) ] [ Designated as safety issue: No ]
- Change from baseline in visual acuity at 3 months post-surgery (intervention) [ Time Frame: 3 months following surgery (intervention) ] [ Designated as safety issue: No ]
- Change from baseline in visual acuity at 12 months post-surgery (intervention) [ Time Frame: 12 months following surgery (intervention) ] [ Designated as safety issue: No ]
- Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 1 month post-surgery (intervention) [ Time Frame: 1 month following surgery (intervention) ] [ Designated as safety issue: No ]
- Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 3 months post-surgery (intervention) [ Time Frame: 3 months following surgery ] [ Designated as safety issue: No ]
- Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 6 months post-surgery (intervention) [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]
- Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 12 months post-surgery (intervention) [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Epiretinal Membrane Surgery without ILM peel |
Procedure: Pars plana vitrectomy and epiretinal membrane peel
23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization
|
| Active Comparator: Epiretinal Membrane Surgery with ILM peel (ICG assisted) |
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
|
| Active Comparator: Combined CE & IOL and ERM surgery without ILM peel |
Procedure: Pars plana vitrectomy and epiretinal membrane peel
23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization
Procedure: CE-IOL
Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant
|
| Active Comparator: Combined CE & IOL and ERM surgery with ILM peel (ICG assisted) |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Tran DB Le, MD | (647)408-2593 | tran.le@utoronto.ca |
| Contact: Charlene Muller, RN, PHN, CCRP | Tel:416-480-5091 | charlene.muller@sunnybrook.ca |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact 6474082593 tran.le@utoronto.ca | |
| Sub-Investigator: Tran DB Le, MD | |
| Principal Investigator: Peter Kertes, MD, FRCSC | |
| Sub-Investigator: Kenneth T Eng, MD, FRCSC | |
| Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Contact: Tran DB Le, MD 6474082593 tran.le@utoronto.ca | |
| Principal Investigator: Wai-Ching Lam, MD, FRCSC | |
| Sub-Investigator: Tran DB Le, MD | |
| Sub-Investigator: Efrem Mandelcorn, MD, FRCSC | |
| Sub-Investigator: Mark Mandelcorn, MD, FRCSC | |
| Sub-Investigator: Robert Devenyi, MD, FRCSC | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Contact: Tran DB Le, MD 6474082593 tran.le@utoronto.ca | |
| Sub-Investigator: Tran DB Le, MD | |
| Principal Investigator: Rajeev Muni, FRCSC, MD | |
More Information
Publications:
| Responsible Party: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01532765 History of Changes |
| Other Study ID Numbers: | 422-2010 |
| Study First Received: | January 13, 2012 |
| Last Updated: | February 13, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Internal limiting membrane Indocyanine green dye |
Additional relevant MeSH terms:
|
Epiretinal Membrane Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 17, 2013