Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
Start Date
2/22/2022
Completion Date
12/31/2026
Summary
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.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
Immediate Vitrectomy
Deferred Vitrectomy
Conditions
Locations
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States
Kent W. Small, MD, AMC
Glendale, California 91203-1971
United States
Salehi Retina Institute Inc.
Huntington Beach, California 92647-8693
United States
Loma Linda University
Loma Linda, California 92354
United States
Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View, California 94040-4123
United States
East Bay Retina Consultants, Inc.
Oakland, California 94609-3028
United States
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California 95817
United States
Macula Retina Vitreous Institute
Torrance, California 90503
United States
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida 32216
United States
Sarasota Retina Institute
Sarasota, Florida 34239
United States
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida 33544
United States
Southeast Retina Center, P.C.
Augusta, Georgia 30909
United States
Thomas Eye Group
Sandy Springs, Georgia 30328
United States
Northwestern University
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
UIC - Department of Ophthalmology and Visual Sciences
Chicago, Illinois 60612
United States
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois 60304
United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana 46290
United States
Mid-America Retina Consultants, P.A.
Overland Park, Kansas 66211
United States
University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas 66208
United States
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana 71291-4452
United States
Elman Retina Group, P.A.
Baltimore, Maryland 21237
United States
Johns Hopkins University
Baltimore, Maryland 21287
United States
Valley Eye Physicians and Surgeons
Ayer, Massachusetts 01432
United States
Joslin Diabetes Center
Boston, Massachusetts 02215
United States
Retina Associates of Michigan
Grand Blanc, Michigan 48439
United States
The Curators of the University of Missouri
Columbia, Missouri 65201-5276
United States
Retina Research Institute, LLC
St Louis, Missouri 63128-1729
United States
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York 13088
United States
Retina Associates of Western NY, P.C.
Rochester, New York 14620-4655
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27517
United States
Retina Vitreous Center
Edmond, Oklahoma 73013-9791
United States
Verum Research LLC
Eugene, Oregon 97401
United States
Cascade Medical Research Institute, LLC
Springfield, Oregon 97477
United States
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania 15146
United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania 15143
United States
Hilton Head Retina Institute
Hilton Head Island, South Carolina 29926
United States
Ophthalmology Ltd.
Sioux Falls, South Dakota 57108
United States
Vanderbilt Eye Institute
Nashville, Tennessee 37232
United States
Austin Research Center for Retina
Austin, Texas 78705
United States
Retina Consultants of Texas
Bellaire, Texas 77401
United States
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas 77030
United States
Texas Retina Associates
Lubbock, Texas 79424
United States
Retinal Consultants of San Antonio
San Antonio, Texas 78240
United States
The Retina Group of Washington
Reston, Virginia 20190
United States
Spokane Eye Clinical Research, PLLC
Spokane, Washington 99204
United States
South Tyneside and Sunderland NHS Trust
Sunderland, Tyne and Wear SR29HP
United Kingdom