Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
Recruiting now · Not applicable
Conditions studied: Epiretinal Membrane
In brief
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.
Key facts
- Study ID
- NCT05145491
- Run by
- Jaeb Center for Health Research
- People needed
- 400
- Starts
- 2022-02-22
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-16
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
- Kent W. Small, MD, AMC — Glendale, California, United States (enrolling)
- Salehi Retina Institute Inc. — Huntington Beach, California, United States (enrolling)
- Loma Linda University — Loma Linda, California, United States (enrolling)
- Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc. — Mountain View, California, United States (enrolling)
- East Bay Retina Consultants, Inc. — Oakland, California, United States (enrolling)
- Regents of the University of California, Davis, DBA University of California, Davis — Sacramento, California, United States (enrolling)
- Macula Retina Vitreous Institute — Torrance, California, United States (enrolling)
- Florida Retina Institute, James A. Staman, MD, PA- Jacksonville — Jacksonville, Florida, United States (enrolling)
- Sarasota Retina Institute — Sarasota, Florida, United States (enrolling)
- SEASHORE RETINA LLC DBA Retina Specialists of Tampa — Wesley Chapel, Florida, United States (enrolling)
- Southeast Retina Center, P.C. — Augusta, Georgia, United States (enrolling)
- Thomas Eye Group — Sandy Springs, Georgia, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- UIC - Department of Ophthalmology and Visual Sciences — Chicago, Illinois, United States (enrolling)
- Illinois Retina Associates SC - Oak Park Site — Oak Park, Illinois, United States (enrolling)
- Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States (enrolling)
- Mid-America Retina Consultants, P.A. — Overland Park, Kansas, United States (enrolling)
- University of Kansas Medical Center Research Institute, Inc. — Prairie Village, Kansas, United States (enrolling)
- Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana — West Monroe, Louisiana, United States (enrolling)
- Elman Retina Group, P.A. — Baltimore, Maryland, United States (enrolling)
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- Valley Eye Physicians and Surgeons — Ayer, Massachusetts, United States (enrolling)
- Joslin Diabetes Center — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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