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Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID05145491

Randomized Trial Comparing Immediate Versus Deferred Surgery for Symptomatic Epiretinal Membranes

Led by Jaeb Center for Health Research · Updated on 2026-01-28

400

Participants Needed

46

Research Sites

N/A

Total Duration

On this page

Sponsors

J

Jaeb Center for Health Research

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to find the best timing for surgery to remove an epiretinal membrane ERM, a common eye condition affecting vision. It compares immediate surgery versus delaying surgery in patients who have significant changes in the central part of the retina but still relatively good vision. The study also seeks to identify factors that predict how well patients do after surgery or how their condition progresses if surgery is delayed. Additionally, it evaluates tools measuring vision distortion and reading speed to better understand their usefulness for ERM patients. Participants are randomly assigned to one of two groups immediate vitrectomy surgery performed within one month of randomization, or deferred vitrectomy surgery which may be done if vision worsens by specific amounts, symptoms worsen, or complications arise. Surgery involves removing the ERM to improve or stabilize vision. Those in the deferred group are monitored regularly and surgery is only performed if certain criteria are met. Throughout the study, participants will have their vision tested at various times up to 36 months to measure changes in visual acuity. Researchers will also assess vision distortion and reading speed to understand symptoms better. The main outcome measured is the mean change in visual acuity from the start of the study to 36 months. Safety and progression of the condition will be monitored, and participants eye health will be closely followed during the study period.

CONDITIONS

Brief Title

Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45 years or older
  • Visual acuity of 20/40 or better (69 letters or more)
  • Epiretinal membrane is the main cause of vision loss
  • Epiretinal membrane is not caused by another condition
  • Symptoms of visual loss or distortion are new or worsening within the past 24 months
  • Epiretinal membrane involves or changes the central 3 mm of the macula on OCT imaging
  • Distortion is present in the central macula area on OCT
  • Immediate vitrectomy surgery is not required; willing to wait at least 4 weeks if vision is stable
  • No medical issues that would prevent surgery
Not Eligible

You will not qualify if you...

  • History of retinal vascular disease
  • History of vitreous hemorrhage causing the epiretinal membrane
  • History of inflammatory eye disease unless mild and fully resolved at least 1 year before enrollment
  • History of diabetic macular edema, retinal vein occlusion, or active uveitis (except mild uveitis resolved over 1 year ago)
  • Prior eye surgery except uncomplicated cataract removal
  • Cataract surgery within 3 months before enrollment
  • Laser or cryosurgery on retina within 1 month before enrollment
  • Pneumatic retinopexy within 1 year before enrollment
  • Current untreated retinal tear or detachment (except treated small tear with limited fluid)
  • Macular hole or degenerative lamellar macular hole
  • Vitreomacular traction near the foveal center
  • Central serous chorioretinopathy
  • Moderate or worse diabetic retinopathy (greater than level 20)

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