Randomized Trial Comparing Immediate Vs. Deferred Surgery for Symptomatic ERM

Description

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.

Conditions

Epiretinal Membrane

Study Overview

Study Details

Study overview

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.

Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

Randomized Trial Comparing Immediate Vs. Deferred Surgery for Symptomatic ERM

Condition
Epiretinal Membrane
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic Arizona, Scottsdale, Arizona, United States, 85259

Glendale

Kent W. Small, MD, AMC, Glendale, California, United States, 91203-1971

Huntington Beach

Salehi Retina Institute Inc., Huntington Beach, California, United States, 92647-8693

Loma Linda

Loma Linda University, Loma Linda, California, United States, 92354

Mountain View

Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc., Mountain View, California, United States, 94040-4123

Oakland

East Bay Retina Consultants, Inc., Oakland, California, United States, 94609-3028

Sacramento

Regents of the University of California, Davis, DBA University of California, Davis, Sacramento, California, United States, 95817

Torrance

Macula Retina Vitreous Institute, Torrance, California, United States, 90503

Jacksonville

Florida Retina Institute, James A. Staman, MD, PA- Jacksonville, Jacksonville, Florida, United States, 32216

Sarasota

Sarasota Retina Institute, Sarasota, Florida, United States, 34239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * 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)
  • * Prior intraocular surgery (except uncomplicated cataract extraction)
  • * Cataract extraction within prior 3 months
  • * Laser or cryosurgical retinopexy within one month of randomization
  • * Pneumatic retinopexy within one year of randomization
  • * Current untreated retinal tear or detachment
  • * Macular hole
  • * Degenerative lamellar macular hole
  • * Vitreomacular traction within 1,500 microns of foveal center
  • * Central serous chorioretinopathy
  • * Nonproliferative diabetic retinopathy or worse (DR severity \>20)

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jaeb Center for Health Research,

Study Record Dates

2026-12-31