Actively Recruiting
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
Led by Jaeb Center for Health Research · Updated on 2026-01-28
400
Participants Needed
46
Research Sites
253 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 years or older
- Visual acuity of 20/40 or better (69 letters or more) due to epiretinal membrane
- Epiretinal membrane is the main cause of vision loss
- Epiretinal membrane is not caused by another condition
- Symptoms of vision loss or distortion are new or worsening in the past 24 months
- Epiretinal membrane involves or alters the central 3 mm of the macula on OCT imaging
- Distortion is present in the central part of the macula due to epiretinal membrane
- Immediate vitrectomy is not required; willing to wait at least 4 weeks if vision is stable
- No known medical problems that would prevent surgery
You will not qualify if you...
- History of retinal vascular disease
- History of vitreous hemorrhage if it caused the epiretinal membrane
- History of inflammatory eye disease unless mild and fully resolved at least one year before randomization
- History of diabetic macular edema, retinal vein occlusion, or uveitis except mild uveitis resolved more than one year ago
- Prior eye surgery except uncomplicated cataract removal
- Cataract surgery within 3 months before enrollment
- Laser or cryosurgical retinopexy within one month before enrollment
- Pneumatic retinopexy within one year before enrollment
- Current untreated retinal tear or detachment (treated tears with limited fluid are allowed)
- Macular hole or degenerative lamellar macular hole (tractional lamellar hole allowed)
- Vitreomacular traction within 1,500 microns of the foveal center
- Central serous chorioretinopathy
- Nonproliferative diabetic retinopathy or worse (severity greater than 20)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Kent W. Small, MD, AMC
Glendale, California, United States, 91203-1971
Actively Recruiting
3
Salehi Retina Institute Inc.
Huntington Beach, California, United States, 92647-8693
Actively Recruiting
4
Loma Linda University
Loma Linda, California, United States, 92354
Actively Recruiting
5
Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View, California, United States, 94040-4123
Actively Recruiting
6
East Bay Retina Consultants, Inc.
Oakland, California, United States, 94609-3028
Actively Recruiting
7
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
8
Macula Retina Vitreous Institute
Torrance, California, United States, 90503
Actively Recruiting
9
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, United States, 32216
Actively Recruiting
10
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Actively Recruiting
11
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida, United States, 33544
Actively Recruiting
12
Southeast Retina Center, P.C.
Augusta, Georgia, United States, 30909
Actively Recruiting
13
Thomas Eye Group
Sandy Springs, Georgia, United States, 30328
Actively Recruiting
14
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
15
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
16
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois, United States, 60304
Actively Recruiting
17
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, United States, 46290
Actively Recruiting
18
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, United States, 66211
Actively Recruiting
19
University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas, United States, 66208
Actively Recruiting
20
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, United States, 71291-4452
Actively Recruiting
21
Elman Retina Group, P.A.
Baltimore, Maryland, United States, 21237
Actively Recruiting
22
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
23
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, United States, 01432
Actively Recruiting
24
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
25
Retina Associates of Michigan
Grand Blanc, Michigan, United States, 48439
Actively Recruiting
26
The Curators of the University of Missouri
Columbia, Missouri, United States, 65201-5276
Actively Recruiting
27
Retina Research Institute, LLC
St Louis, Missouri, United States, 63128-1729
Actively Recruiting
28
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States, 13088
Actively Recruiting
29
Retina Associates of Western NY, P.C.
Rochester, New York, United States, 14620-4655
Actively Recruiting
30
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
31
Retina Vitreous Center
Edmond, Oklahoma, United States, 73013-9791
Actively Recruiting
32
Verum Research LLC
Eugene, Oregon, United States, 97401
Actively Recruiting
33
Cascade Medical Research Institute, LLC
Springfield, Oregon, United States, 97477
Actively Recruiting
34
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
35
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
36
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, United States, 15143
Actively Recruiting
37
Hilton Head Retina Institute
Hilton Head Island, South Carolina, United States, 29926
Actively Recruiting
38
Ophthalmology Ltd.
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
39
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
Actively Recruiting
40
Austin Research Center for Retina
Austin, Texas, United States, 78705
Actively Recruiting
41
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
Actively Recruiting
42
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, United States, 77030
Actively Recruiting
43
Texas Retina Associates
Lubbock, Texas, United States, 79424
Actively Recruiting
44
Retinal Consultants of San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
45
Spokane Eye Clinical Research, PLLC
Spokane, Washington, United States, 99204
Actively Recruiting
46
South Tyneside and Sunderland NHS Trust
Sunderland, Tyne and Wear, United Kingdom, SR29HP
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here