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Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

NCT05145491 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-01-28

No results posted yet for this 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

  • Epiretinal Membrane

Interventions

PROCEDURE

Immediate Vitrectomy

Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization

PROCEDURE

Deferred Vitrectomy

Vitrectomy may be performed only if at least one of the following criteria is met: 1. Decrease in visual acuity ≥10 letters from baseline at a single visit presumed to be from ERM 2. Decrease in visual acuity ≥5 letters from baseline at two consecutive visits presumed to be from ERM a. Visits must be at least one month apart 3. Participant actively requests surgery due to worsening symptoms 4. Complication requires prompt surgical intervention (e.g., macular hole, retinal detachment, non-clearing vitreous hemorrhage)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Eye Institute (NEI)

    collaborator NIH

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Jaeb Center for Health Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145491 on ClinicalTrials.gov