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Duration of Face Down Positioning for Full-Thickness Macular Hole Repair

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 29, 2024 (before its estimated May 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: May 15, 2024 to May 15, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2023 to Nov 21, 2023
    v4
  3. Start date: Sep 10, 2023 to Oct 1, 2023v3
  4. Start date: Aug 15, 2023 to Sep 10, 2023
    • Secondary endpoints: details revised at 2 of 6 entries
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.
Trial Details
NCT Number NCT06000111
Lead Sponsor St. Joseph's Healthcare Hamilton
Conditions
(from sponsor)		 Macular Holes
Related terms Retinal Perforations
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov