Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM (NCT05145491)
Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Scottsdale, Arizona
Age range: 50 Years
🧪 Interventions in This Study
- Immediate Vitrectomy (PROCEDURE)
- Deferred Vitrectomy (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- Mayo Clinic Arizona — Scottsdale, Arizona
- Kent W. Small, MD, AMC — Glendale, California
- Salehi Retina Institute Inc. — Huntington Beach, California
- Loma Linda University — Loma Linda, California
- Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc. — Mountain View, California
- East Bay Retina Consultants, Inc. — Oakland, California
- Regents of the University of California, Davis, DBA University of California, Davis — Sacramento, California
- Macula Retina Vitreous Institute — Torrance, California
- Florida Retina Institute, James A. Staman, MD, PA- Jacksonville — Jacksonville, Florida
- Sarasota Retina Institute — Sarasota, Florida
- SEASHORE RETINA LLC DBA Retina Specialists of Tampa — Wesley Chapel, Florida
- Southeast Retina Center, P.C. — Augusta, Georgia
- Thomas Eye Group — Sandy Springs, Georgia
- Northwestern University — Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois
- UIC - Department of Ophthalmology and Visual Sciences — Chicago, Illinois
- Illinois Retina Associates SC - Oak Park Site — Oak Park, Illinois
- Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana
- Mid-America Retina Consultants, P.A. — Overland Park, Kansas
- University of Kansas Medical Center Research Institute, Inc. — Prairie Village, Kansas
- Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana — West Monroe, Louisiana
- Elman Retina Group, P.A. — Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland
- Valley Eye Physicians and Surgeons — Ayer, Massachusetts
- Joslin Diabetes Center — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (480) 301-8085
Email: esmeralda-meckelburg.alex@mayo.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.