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Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
NCT05145491 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05145491
The ClinicalTrials.gov registry entry for NCT05145491 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05145491 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05145491?
The interventions under investigation include: Immediate Vitrectomy (PROCEDURE), Deferred Vitrectomy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05145491?
This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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