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

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

Treatments tested in this trial

  • Immediate Vitrectomy
  • Deferred Vitrectomy

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jaeb Center for Health Research

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Eye Institute (NEI)

Collaborator

Juvenile Diabetes Research Foundation

Collaborator