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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Consecutive patients with an idiopathic full-thickness macular hole

• Symptom duration of less than 6 months

• Patient must agree to participate in this investigation

Locations
Other Locations
Canada
St. Joseph's Hospital King Campus
RECRUITING
Stoney Creek
Contact Information
Primary
Varun Chaudhary, MD, FRCSC
vchaudh@mcmaster.ca
905-573-7777
Backup
Keean Nanji, MD
Keean.Nanji@medportal.ca
905-573-4848
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Face-Down Positioning for 3-Days and Nights
Patients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.
Active_comparator: Face-Down Positioning for 7-Days and Nights
Patients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.
Related Therapeutic Areas
Sponsors
Leads: St. Joseph's Healthcare Hamilton

This content was sourced from clinicaltrials.gov