Recruiting

3 vs. 7 Days

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT06000111

Conditions

Macular Holes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3 Days of face-down positioning

7 Days of face-down positioning

Study Details

Brief 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

Study ID

NCT06000111

Start date

Nov 21, 2023

Status verified date

Nov, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

May 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Consecutive patients with an idiopathic full-thickness macular hole
  • Symptom duration of less than 6 months
  • Patient must agree to participate in this investigation

Exclusion Criteria:

  • Macular hole minimum diameter >1000 μm
  • A history of high myopia (> -6)
  • Traumatic macular hole
  • Amblyopia
  • Retinal vein occlusion
  • Inflammatory eye diseases
  • Patients found to have a retinal tear during either the pre-operative assessment or intraoperatively

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Recruitment Rate [ Time Frame: The recruitment rate will be calculated during the recruitment period. ]
  • Retention Rate [ Time Frame: The retention rate will be calculated at 3-months post-operatively. ]
  • Completion Rate [ Time Frame: The completion rate will be calculated at 3-months post-operatively. ]
  • Recruitment Time [ Time Frame: The recruitment time will be calculated during the recruitment period. ]

Central Contacts and Locations

Central contacts

Varun Chaudhary, MD, FRCSC

905-573-7777vchaudh@mcmaster.ca

Keean Nanji, MD

905-573-4848Keean.Nanji@medportal.ca

Locations

St. Joseph's Hospital King Campus

Recruiting

Stoney Creek, Ontario, Canada, L8G 5E4

Contacts

Keean Nanji, MD

6474575454Keean.Nanji@medportal.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2024-11-29.