Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia but none have ever been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Vitrectomy may be performed only if at least one of the following criteria is met: 1. Decrease in visual acuity ≥10 letters from baseline at a single visit presumed to be from ERM 2. Decrease in visual acuity ≥5 letters from baseline at two consecutive visits presumed to be from ERM a. Visits must be at least one month apart 3. Participant actively requests surgery due to worsening symptoms 4. Complication requires prompt surgical intervention (e.g., macular hole, retinal detachment, non-clearing vitreous hemorrhage)
Mayo Clinic Arizona
Scottsdale, Arizona, United States
RECRUITINGKent W. Small, MD, AMC
Glendale, California, United States
RECRUITINGSalehi Retina Institute Inc.
Huntington Beach, California, United States
RECRUITINGLoma Linda University
Loma Linda, California, United States
Mean change in visual acuity letter score from baseline to 36 months
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Time frame: Baseline to 36 months
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Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View, California, United States
RECRUITINGEast Bay Retina Consultants, Inc.
Oakland, California, United States
RECRUITINGRegents of the University of California, Davis, DBA University of California, Davis
Sacramento, California, United States
RECRUITINGMacula Retina Vitreous Institute
Torrance, California, United States
RECRUITINGFlorida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, United States
RECRUITINGSarasota Retina Institute
Sarasota, Florida, United States
RECRUITING...and 36 more locations