RecruitingNot Applicable

Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

United States400 participantsStarted 2022-02-22

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Age ≥ 45 years * E-ETDRS visual acuity 20/40 or better (≥69 letters) o ERM must be thought to be the primary cause of vision loss * ERM meeting the following criteria, according to the investigator * ERM is not secondary to another condition * Symptoms of visual loss and/or distortion (in the opinion of the investigator, the ERM is contributing to the participant's symptoms); either new or worsening in the past 24 months * Epiretinal membrane involving or altering the central 3 mm of the macula on OCT * Distortion within the central subfield due to ERM on OCT * Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 weeks to see if vision remains stable without having to proceed to vitrectomy) * No known medical problems that will be a contraindication to surgery Key Exclusion Criteria: * History of retinal vascular disease * History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did not cause the ERM in the investigator's opinion * 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) * Prior intraocular surgery (except uncomplicated cataract extraction) * Cataract extraction with…

What they're measuring

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

Timeframe: Baseline to 36 months

Trial details

NCT IDNCT05145491

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31