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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Immediate Vitrectomy
Procedure/SurgerySurgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization
Deferred Vitrectomy
Procedure/SurgeryVitrectomy 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
Trial outcomes
Primary outcomes
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.
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