Comparing immediate and delayed surgery for eye membrane issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.