RECRUITING

Randomized Trial Comparing Immediate Vs. Deferred Surgery for Symptomatic ERM

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

Quick Facts

Study Start:2022-02-22
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05145491

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 45 years
  2. * E-ETDRS visual acuity 20/40 or better (≥69 letters)
  3. * ERM meeting the following criteria, according to the investigator
  4. * ERM is not secondary to another condition
  5. * 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
  6. * Epiretinal membrane involving or altering the central 3 mm of the macula on OCT
  7. * Distortion within the central subfield due to ERM on OCT
  8. * 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)
  9. * No known medical problems that will be a contraindication to surgery
  1. * History of retinal vascular disease
  2. * History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM
  3. * History of inflammatory disease unless mild and completely resolved at least one year prior to randomization
  4. * History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis (except mild uveitis that resolved \>1 year prior to randomization)
  5. * Prior intraocular surgery (except uncomplicated cataract extraction)
  6. * Cataract extraction within prior 3 months
  7. * Laser or cryosurgical retinopexy within one month of randomization
  8. * Pneumatic retinopexy within one year of randomization
  9. * Current untreated retinal tear or detachment
  10. * Macular hole
  11. * Degenerative lamellar macular hole
  12. * Vitreomacular traction within 1,500 microns of foveal center
  13. * Central serous chorioretinopathy
  14. * Nonproliferative diabetic retinopathy or worse (DR severity \>20)

Contacts and Locations

Study Locations (Sites)

Mayo Clinic Arizona
Scottsdale, Arizona, 85259
United States
Kent W. Small, MD, AMC
Glendale, California, 91203-1971
United States
Salehi Retina Institute Inc.
Huntington Beach, California, 92647-8693
United States
Loma Linda University
Loma Linda, California, 92354
United States
Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc.
Mountain View, California, 94040-4123
United States
East Bay Retina Consultants, Inc.
Oakland, California, 94609-3028
United States
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California, 95817
United States
Macula Retina Vitreous Institute
Torrance, California, 90503
United States
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, 32216
United States
Sarasota Retina Institute
Sarasota, Florida, 34239
United States
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida, 33544
United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909
United States
Thomas Eye Group
Sandy Springs, Georgia, 30328
United States
Northwestern University
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois, 60304
United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, 46290
United States
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, 66211
United States
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, 71291-4452
United States
Elman Retina Group, P.A.
Baltimore, Maryland, 21237
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, 01432
United States
Joslin Diabetes Center
Boston, Massachusetts, 02215
United States
Retina Associates of Michigan
Grand Blanc, Michigan, 48439
United States
The Curators of the University of Missouri
Columbia, Missouri, 65201-5276
United States
Retina Research Institute, LLC
Saint Louis, Missouri, 63128-1729
United States
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, 13088
United States
Retina Associates of Western NY, P.C.
Rochester, New York, 14620-4655
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
United States
Retina Vitreous Center
Edmond, Oklahoma, 73013-9791
United States
Verum Research LLC
Eugene, Oregon, 97401
United States
Cascade Medical Research Institute, LLC
Springfield, Oregon, 97477
United States
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, 15146
United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, 15143
United States
Hilton Head Retina Institute
Hilton Head Island, South Carolina, 29926
United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
United States
Austin Research Center for Retina
Austin, Texas, 78705
United States
Retina Consultants of Texas
Bellaire, Texas, 77401
United States
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, 77030
United States
Texas Retina Associates
Lubbock, Texas, 79424
United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
United States
Spokane Eye Clinical Research, PLLC
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-22
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-02-22
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Epiretinal Membrane