Comparing immediate and delayed surgery for eye membrane issues

Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

Not applicable Interventional Jaeb Center for Health Research · NCT05145491

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

PhaseNot applicable
Study typeInterventional
Enrollment400 (estimated)
Ages50 Years and up
SexAll
SponsorJaeb Center for Health Research Academic / other
Locations46 sites (Scottsdale, Arizona and 45 other locations)
Trial IDNCT05145491 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

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Epiretinal Membrane
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.