NCT06000111

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

Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Holes

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2023-11-21
• Primary completion: 2025-05-15
• Completion: 2025-12-31
• First posted: 2023-08-21
• Last updated: 2024-11-29

Locations

1 site across 1 country: Canada