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RECRUITING
NCT06000111
NA

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

Sponsor: St. Joseph's Healthcare Hamilton

View on ClinicalTrials.gov

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

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.

Locations (1)

St. Joseph's Hospital King Campus

Stoney Creek, Ontario, Canada