Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Conditions

• Epiretinal Membrane

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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 Dates

Start date

Feb 22, 2022

Status verified

Sep 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Immediate Vitrectomy
• Other: Deferred Vitrectomy

Primary Outcome Measure

Mean change in visual acuity letter score from baseline to 36 months [ Time Frame: Baseline to 36 months ]

Locations (45)

Find similar trials in Scottsdale, AZ

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