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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01532765
First received: January 13, 2012
Last updated: February 13, 2012
Last verified: February 2012
  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

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 ] [ 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 ]

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 ] [ 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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         
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         
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
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 July 22, 2014