Back to Trials
NCT05145491NARecruiting

Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Jaeb Center for Health Research

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

Key Inclusion Criteria: * Age ≥ 45 years * E-ETDRS visual acuity 20/40 or better (≥69 letters) o ERM must be thought to be the primary cause of vision loss * ERM meeting the following criteria, according to the investigator * ERM is not secondary to another condition * Symptoms of visual loss and/or distortion (in the opinion of the investigator, the ERM is contributing to the participant's symptoms); either new or worsening in the past 24 months * Epiretinal membrane involving or altering the central 3 mm of the macula on OCT * Distortion within the central subfield due to ERM on OCT * Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 weeks to see if vision remains stable without having to proceed to vitrectomy) * No known medical problems that will be a contraindication to surgery Key Exclusion Criteria: * History of retinal vascular disease * History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did not cause the ERM in the investigator's opinion * History of inflammatory disease unless mild and completely resolved at least one year prior to randomization * History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis (except mild uveitis that resolved \>1 year prior to randomization) * Prior intraocular surgery (except uncomplicated cataract extraction) * Cataract extraction within prior 3 months * Laser or cryosurgical retinopexy within one month of randomization * Pneumatic retinopexy within one year of randomization * Current untreated retinal tear or detachment o A previously treated retinal tear with up to one disc diameter radius of subretinal fluid is permitted * Macular hole * Degenerative lamellar macular hole o ERM foveoschisis ("tractional" lamellar hole) is permitted * Vitreomacular traction within 1,500 microns of foveal center * Central serous chorioretinopathy * Nonproliferative diabetic retinopathy or worse (DR severity \>20)

Interventions

PROCEDURE

Immediate Vitrectomy

PROCEDURE

Deferred Vitrectomy

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Epiretinal Membrane

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