Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorJaeb Center for Health Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 45 years

E-ETDRS visual acuity 20/40 or better (≥69 letters)

ERM meeting the following criteria, according to the investigator

ERM is not secondary to another condition

Disqualifiers

History of retinal vascular disease

History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM

History of inflammatory disease unless mild and completely resolved at least one year prior to randomization

History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis (except mild uveitis that resolved >1 year prior to randomization)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate Vitrectomy

    Procedure/Surgery

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

  • Deferred Vitrectomy

    Procedure/Surgery

    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)

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Immediate VitrectomyActive comparator 1 intervention
Group B: Deferred VitrectomyOther 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in visual acuity letter score from baseline to 36 months

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.

Time frame
Baseline to 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Jaeb Center for Health Research

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Eye Institute (NEI)

Collaborator

Juvenile Diabetes Research Foundation

Collaborator