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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532765
First Posted: February 14, 2012
Last Update Posted: December 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Randomized Clinical Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention) [ Time Frame: 1 month following surgery ]
  • Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery [ Time Frame: 12 months following surgery ]
  • Change from baseline in visual acuity at 1 month post-surgery (intervention) [ Time Frame: 1 month following surgery (intervention) ]
  • Change from baseline in visual acuity at 3 months post-surgery (intervention) [ Time Frame: 3 months following surgery (intervention) ]
  • Change from baseline in visual acuity at 12 months post-surgery (intervention) [ Time Frame: 12 months following surgery (intervention) ]
  • 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) ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: September 2016 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532765


Contacts
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

Locations
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         
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         
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         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
  More Information

Publications:

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01532765     History of Changes
Other Study ID Numbers: 422-2010
First Submitted: January 13, 2012
First Posted: February 14, 2012
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by Sunnybrook Health Sciences Centre:
Internal limiting membrane
Indocyanine green dye

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases