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

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ClinicalTrials.gov Identifier: NCT01532765
Recruitment Status : Terminated (Resident Project which was not followed through after graduation)
First Posted : February 14, 2012
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Procedure: Pars plana vitrectomy and epiretinal membrane peel Procedure: ILM peel assisted by ICG Procedure: CE-IOL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
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
Study Start Date : September 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : March 22, 2017

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention) [ Time Frame: 1 month following surgery ]
  2. Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery [ Time Frame: 12 months following surgery ]
  3. Change from baseline in visual acuity at 1 month post-surgery (intervention) [ Time Frame: 1 month following surgery (intervention) ]
  4. Change from baseline in visual acuity at 3 months post-surgery (intervention) [ Time Frame: 3 months following surgery (intervention) ]
  5. Change from baseline in visual acuity at 12 months post-surgery (intervention) [ Time Frame: 12 months following surgery (intervention) ]
  6. 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) ]
  7. 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 ]
  8. 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 ]
  9. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
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

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


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Publications:

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01532765    
Other Study ID Numbers: 422-2010
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: December 2015
Keywords provided by Sunnybrook Health Sciences Centre:
Internal limiting membrane
Indocyanine green dye
Additional relevant MeSH terms:
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Epiretinal Membrane
Retinal Diseases
Eye Diseases