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Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
Sponsor: St. Joseph's Healthcare Hamilton
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.
Official title: Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-11-21
Completion Date
2025-12-31
Last Updated
2024-11-29
Healthy Volunteers
No
Conditions
Interventions
3 Days of face-down positioning
Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
7 Days of face-down positioning
Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.
Locations (1)
St. Joseph's Hospital King Campus
Stoney Creek, Ontario, Canada