Randomized Trial Comparing Immediate Vs. Deferred Surgery for Symptomatic ERM
- Conditions
- Epiretinal Membrane
- Interventions
- Procedure: Immediate VitrectomyProcedure: Deferred Vitrectomy
- Registration Number
- NCT05145491
- Lead Sponsor
- Jaeb Center for Health Research
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
-
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
-
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Vitrectomy Immediate Vitrectomy - Deferred Vitrectomy Deferred Vitrectomy -
- Primary Outcome Measures
Name Time Method Mean change in visual acuity letter score from baseline to 36 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
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
🇺🇸Saint 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
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