Randomized Trial Comparing Immediate versus Deferred Surgery for ERM
Research type
Research Study
Full title
Randomized Trial Comparing Immediate versus Deferred Surgery for Symptomatic Epiretinal Membranes
IRAS ID
340700
Contact name
David Steel
Contact email
Sponsor organisation
Jaeb Center for Health Research (JCHR)
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
UG1EY014231 , U.S. NIH Grant/Contract
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Epiretinal membranes (ERM) that distort and pull the central macular retina out of shape with varying degrees of reduced vision are a common and age related phenomena affecting up to 5% of the population over 60 years old. Vitrectomy to remove ERM is one of the most common procedures performed by retinal surgeons and often improves vision in those affected. However patients who present with significant macular changes on optical coherence tomography (OCT) secondary to ERM 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 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.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0245
Date of REC Opinion
14 Mar 2025
REC opinion
Further Information Favourable Opinion