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Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Study acronym: Protocol AM
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study sites: 47 to 48v23
  2. Minor Study sites: 46 to 47v22
  3. Minor Study sites: 45 to 46v21
  4. Minor Site contacts updated at 24 of 45 sitesv20
  5. Minor Study sites: 44 to 45v19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Study sites: 43 to 44v18
  2. Minor Study sites: 41 to 43v17
  3. Minor Study sites: 40 to 41v16
  4. Minor Study sites: 39 to 40v15
  5. Minor Study sites: 38 to 39v14
  6. Minor Study sites: 35 to 38v13
  7. Minor Eligibility criteria shortened, about 2 wordsv12
  8. Minor Study sites: 34 to 35v11
  9. Minor Eligibility criteria expanded, about 52 wordsv10
  10. Minor Study sites: 28 to 34v9
  11. Minor Study sites: 27 to 28v8
  12. Minor Study sites: 24 to 27v7
  13. Minor Study sites: 23 to 24v6
  14. Minor Study sites: 19 to 23v5
  15. Notable Primary and study completion dates: Dec 21, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 45 words
    v4
  16. Minor Study sites: 6 to 19v3
  17. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Oct 16, 2025 to Dec 21, 2025
    • Start date changed from estimate of Jan 16, 2022 to Feb 22, 2022
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia but none have ever been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.
Trial Details
NCT Number NCT05145491
Lead Sponsor Jaeb Center for Health Research
Collaborators: National Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation
Conditions
(from sponsor)
Epiretinal Membrane
Related terms Epiretinal Membrane
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov