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Behavioral Intervention

Face-Down Positioning Duration for Macular Hole Repair

N/A
Recruiting
Led By Varun Chaudhary, MD, FRCSC
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptom duration of less than 6 months
Consecutive patients with an idiopathic full-thickness macular hole
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-months post-operatively
Awards & highlights

Study Summary

This trial will compare 3 vs. 7 days of face-down positioning after surgery to repair a gap in the retina, to determine which is better for healing and vision.

Who is the study for?
This trial is for patients with a recent (less than 6 months) idiopathic full-thickness macular hole. Participants must agree to follow the study procedures, which include lying face down for several days after eye surgery.Check my eligibility
What is being tested?
The study compares two different durations of face-down positioning—3 days versus 7 days—after vitrectomy surgery to repair a macular hole in the retina. It aims to determine which duration is more effective and feasible.See study design
What are the potential side effects?
Potential side effects may include discomfort from maintaining a face-down position for an extended period, possible neck or back pain, and general inconvenience affecting quality of life.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My symptoms started less than 6 months ago.
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I have a macular hole in my eye not caused by known diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completion Rate
Recruitment Rate
Recruitment Time
+1 more
Secondary outcome measures
Best-Corrected Visual Acuity (BCVA)
Compliance with Face Down Positioning
Complication Rates
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Face-Down Positioning for 3-Days and NightsExperimental Treatment1 Intervention
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.
Group II: Face-Down Positioning for 7-Days and NightsActive Control1 Intervention
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.

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Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
197 Previous Clinical Trials
26,408 Total Patients Enrolled
Varun Chaudhary, MD, FRCSCPrincipal InvestigatorMcMaster University, St. Joseph's Hospital
1 Previous Clinical Trials
70 Total Patients Enrolled
~27 spots leftby Jun 2025
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