Comparing immediate and delayed surgery for eye membrane issues
Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes
This study is testing whether having eye surgery right away or waiting a bit longer helps people with vision problems from eye membrane issues see better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Jaeb Center for Health Research Academic / other |
| Locations | 46 sites (Scottsdale, Arizona and 45 other locations) |
| Trial ID | NCT05145491 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the outcomes of immediate versus deferred vitrectomy surgery for patients with symptomatic epiretinal membranes (ERM). It aims to determine whether delaying surgery affects visual acuity and to identify predictors of outcomes based on the timing of the procedure. The study will also explore the use of objective measures of visual distortion in evaluating ERMs. Participants will be monitored to assess the impact of their chosen treatment approach on their vision over time.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 and older with good vision (20/40 or better) who have symptomatic ERM believed to be the primary cause of their vision issues.
Not a fit: Patients with a history of retinal vascular disease or those requiring immediate surgery due to severe vision loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the optimal timing for surgery, potentially improving visual outcomes for patients with ERM.
How similar studies have performed: While the approach of comparing immediate and deferred surgery is common, the specific use of objective measures of visual distortion in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
o A previously treated retinal tear with up to one disc diameter radius of subretinal fluid is permitted
* Macular hole
* Degenerative lamellar macular hole
o ERM foveoschisis ("tractional" lamellar hole) is permitted
* Vitreomacular traction within 1,500 microns of foveal center
* Central serous chorioretinopathy
* Nonproliferative diabetic retinopathy or worse (DR severity \>20)
Where this trial is running
Scottsdale, Arizona and 45 other locations
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (Recruiting)
- Kent W. Small, MD, AMC — Glendale, California, United States (Recruiting)
- Salehi Retina Institute Inc. — Huntington Beach, California, United States (Recruiting)
- Loma Linda University — Loma Linda, California, United States (Recruiting)
- Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc. — Mountain View, California, United States (Recruiting)
- East Bay Retina Consultants, Inc. — Oakland, California, United States (Recruiting)
- Regents of the University of California, Davis, DBA University of California, Davis — Sacramento, California, United States (Recruiting)
- Macula Retina Vitreous Institute — Torrance, California, United States (Recruiting)
- Florida Retina Institute, James A. Staman, MD, PA- Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Sarasota Retina Institute — Sarasota, Florida, United States (Recruiting)
- SEASHORE RETINA LLC DBA Retina Specialists of Tampa — Wesley Chapel, Florida, United States (Recruiting)
- Southeast Retina Center, P.C. — Augusta, Georgia, United States (Recruiting)
- Thomas Eye Group — Sandy Springs, Georgia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- Illinois Retina Associates SC - Oak Park Site — Oak Park, Illinois, United States (Recruiting)
- Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States (Recruiting)
- Mid-America Retina Consultants, P.A. — Overland Park, Kansas, United States (Recruiting)
- University of Kansas Medical Center Research Institute, Inc. — Prairie Village, Kansas, United States (Recruiting)
- Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana — West Monroe, Louisiana, United States (Recruiting)
- Elman Retina Group, P.A. — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Valley Eye Physicians and Surgeons — Ayer, Massachusetts, United States (Recruiting)
- Joslin Diabetes Center — Boston, Massachusetts, United States (Recruiting)
- Retina Associates of Michigan — Grand Blanc, Michigan, United States (Recruiting)
- The Curators of the University of Missouri — Columbia, Missouri, United States (Recruiting)
- Retina Research Institute, LLC — St Louis, Missouri, United States (Recruiting)
- Retina-Vitreous Surgeons of Central NY, PC — Liverpool, New York, United States (Recruiting)
- Retina Associates of Western NY, P.C. — Rochester, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Retina Vitreous Center — Edmond, Oklahoma, United States (Recruiting)
- Verum Research LLC — Eugene, Oregon, United States (Recruiting)
- Cascade Medical Research Institute, LLC — Springfield, Oregon, United States (Recruiting)
- Retina-Vitreous Consultants, Inc. — Monroeville, Pennsylvania, United States (Recruiting)
- The Trustees of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Pittsburg Clinical Trial Consortium — Sewickley, Pennsylvania, United States (Recruiting)
- Hilton Head Retina Institute — Hilton Head Island, South Carolina, United States (Recruiting)
- Ophthalmology Ltd. — Sioux Falls, South Dakota, United States (Recruiting)
- Vanderbilt Eye Institute — Nashville, Tennessee, United States (Recruiting)
- Austin Research Center for Retina — Austin, Texas, United States (Recruiting)
- Retina Consultants of Texas — Bellaire, Texas, United States (Recruiting)
- Baylor College of Medicine, Baylor Eye Physicians and Surgeons — Houston, Texas, United States (Recruiting)
- Texas Retina Associates — Lubbock, Texas, United States (Recruiting)
- Retinal Consultants of San Antonio — San Antonio, Texas, United States (Recruiting)
- Spokane Eye Clinical Research, PLLC — Spokane, Washington, United States (Recruiting)
- South Tyneside and Sunderland NHS Trust — Sunderland, Tyne and Wear, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.