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NCT05145491 · ClinicalTrials.gov registry record · NA
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
A NA study of Epiretinal Membrane, sponsored by Jaeb Center for Health Research.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT05145491: Recruiting NA study of Epiretinal Membrane, sponsored by Jaeb Center for Health Research.
NCT05145491 is a NA study of Epiretinal Membrane that is actively recruiting participants, run by Jaeb Center for Health Research. The registered enrollment target is 400 participants, below the 1,098-participant average among 3 other Epiretinal Membrane trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05145491, a NA study of Epiretinal Membrane, is actively recruiting participants, sponsored by Jaeb Center for Health Research.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Immediate Vitrectomy
- PROCEDURE Deferred Vitrectomy
Study Locations (20)
California
- Kent W. Small, MD, AMC - Glendale
- Salehi Retina Institute Inc. - Huntington Beach
- Loma Linda University - Loma Linda
- Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc. - Mountain View
- East Bay Retina Consultants, Inc. - Oakland
- Regents of the University of California, Davis, DBA University of California, Davis - Sacramento
- Macula Retina Vitreous Institute - Torrance
Florida
- Florida Retina Institute, James A. Staman, MD, PA- Jacksonville - Jacksonville
- Sarasota Retina Institute - Sarasota
- SEASHORE RETINA LLC DBA Retina Specialists of Tampa - Wesley Chapel
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
- Illinois Retina Associates SC - Oak Park Site - Oak Park
Georgia
- Southeast Retina Center, P.C. - Augusta
- Thomas Eye Group - Sandy Springs
Kansas
- Mid-America Retina Consultants, P.A. - Overland Park
- University of Kansas Medical Center Research Institute, Inc. - Prairie Village
Arizona
- Mayo Clinic Arizona - Scottsdale
Indiana
- Raj K. Maturi, M.D., P.C. - Indianapolis
Louisiana
- Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana - West Monroe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2022-02-22 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05145491 shows while recruiting
NCT05145491 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,098-participant average among 3 other Epiretinal Membrane trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Epiretinal Membrane appearing as the primary indexed condition, and to 2 interventions - of which Immediate Vitrectomy is the first listed.
NCT05145491 names 20 study sites across 8 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05145491 about?
NCT05145491 is a clinical study titled "Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM". 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/...
What is the current status of trial NCT05145491?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2022-02-22. Estimated completion is 2026-12-31.
What conditions does trial NCT05145491 study?
This clinical trial studies the following conditions: Epiretinal Membrane.
What interventions are being tested in trial NCT05145491?
The interventions under investigation include: Immediate Vitrectomy (PROCEDURE), Deferred Vitrectomy (PROCEDURE).
Who is sponsoring clinical trial NCT05145491?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05145491 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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