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

NCT06000111 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Varun Chaudhary, MD, FRCSC · McMaster University, St. Joseph's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2025-05-15
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000111 on ClinicalTrials.gov