Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
- Conditions
- Epiretinal Membrane
- Registration Number
- NCT05145491
- Lead Sponsor
- Jaeb Center for Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br> - Age = 45 years<br><br> - E-ETDRS visual acuity 20/40 or better (=69 letters)<br><br> o ERM must be thought to be the primary cause of vision loss<br><br> - ERM meeting the following criteria, according to the investigator<br><br> - ERM is not secondary to another condition<br><br> - Symptoms of visual loss and/or distortion (in the opinion of the investigator,<br> the ERM is contributing to the participant's symptoms); either new or worsening<br> in the past 24 months<br><br> - Epiretinal membrane involving or altering the central 3 mm of the macula on OCT<br><br> - Distortion within the central subfield due to ERM on OCT<br><br> - Immediate vitrectomy not required (investigator and participant are willing to wait<br> at least 4 weeks to see if vision remains stable without having to proceed to<br> vitrectomy)<br><br> - No known medical problems that will be a contraindication to surgery<br><br>Key Exclusion Criteria:<br><br> - History of retinal vascular disease<br><br> - History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the<br> ERM<br><br> o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did<br> not cause the ERM in the investigator's opinion<br><br> - History of inflammatory disease unless mild and completely resolved at least one<br> year prior to randomization<br><br> - History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis<br> (except mild uveitis that resolved >1 year prior to randomization)<br><br> - Prior intraocular surgery (except uncomplicated cataract extraction)<br><br> - Cataract extraction within prior 3 months<br><br> - Laser or cryosurgical retinopexy within one month of randomization<br><br> - Pneumatic retinopexy within one year of randomization<br><br> - Current untreated retinal tear or detachment<br><br> o A previously treated retinal tear with up to one disc diameter radius of<br> subretinal fluid is permitted<br><br> - Macular hole<br><br> - Degenerative lamellar macular hole<br><br> o ERM foveoschisis (tractional lamellar hole) is permitted<br><br> - Vitreomacular traction within 1,500 microns of foveal center<br><br> - Central serous chorioretinopathy<br><br> - Nonproliferative diabetic retinopathy or worse (DR severity >20)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in visual acuity letter score from baseline to 36 months
- Secondary Outcome Measures
Name Time Method