Clinical Trial

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

Recruiting
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.
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-08-13; most recent amendment 2024-11-26.
Status change: Not Yet Recruiting → Recruiting 2023-11-21
Trial Details
NCT Number NCT06000111
Lead Sponsor St. Joseph's Healthcare Hamilton
Conditions Macular Holes
Enrollment 40 participants
Start Date 2023-11-21
Primary Completion 2025-05-15 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-29