Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
NCT ID: NCT05145491
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
400 participants
INTERVENTIONAL
2022-02-22
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of a New Surgical Treatment of Macular Hole Retinal Detachment in High Myopia
NCT03383731
Outcomes Based on the Pre-operative Integrity of IS/OS Junction in Idiopathic Epimacular Membrane Surgery
NCT04158791
Fourier Transformed Infrared Spectroscopy in Macular Surgery
NCT03452748
"Cataract Surgery in Eyes With Epiretinal Membrane"
NCT03404323
Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
NCT02896972
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate Vitrectomy
Immediate Vitrectomy
Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Deferred Vitrectomy
Deferred Vitrectomy
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immediate Vitrectomy
Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Deferred Vitrectomy
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
National Eye Institute (NEI)
NIH
Juvenile Diabetes Research Foundation
OTHER
Jaeb Center for Health Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Kent W. Small, MD, AMC
Glendale, California, United States
Salehi Retina Institute Inc.
Huntington Beach, California, United States
Loma Linda University
Loma Linda, California, United States
Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View, California, United States
East Bay Retina Consultants, Inc.
Oakland, California, United States
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California, United States
Macula Retina Vitreous Institute
Torrance, California, United States
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida, United States
Southeast Retina Center, P.C.
Augusta, Georgia, United States
Thomas Eye Group
Sandy Springs, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, United States
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, United States
University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas, United States
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, United States
Elman Retina Group, P.A.
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Retina Associates of Michigan
Grand Blanc, Michigan, United States
The Curators of the University of Missouri
Columbia, Missouri, United States
Retina Research Institute, LLC
St Louis, Missouri, United States
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States
Retina Associates of Western NY, P.C.
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Retina Vitreous Center
Edmond, Oklahoma, United States
Verum Research LLC
Eugene, Oregon, United States
Cascade Medical Research Institute, LLC
Springfield, Oregon, United States
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, United States
Hilton Head Retina Institute
Hilton Head Island, South Carolina, United States
Ophthalmology Ltd.
Sioux Falls, South Dakota, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Austin Research Center for Retina
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, United States
Texas Retina Associates
Lubbock, Texas, United States
Retinal Consultants of San Antonio
San Antonio, Texas, United States
Spokane Eye Clinical Research, PLLC
Spokane, Washington, United States
South Tyneside and Sunderland NHS Trust
Sunderland, Tyne and Wear, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DRCR.net Protocol AM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.