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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-months post-operatively

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion Rate

Recruitment Rate

Recruitment Time

+1 more

Secondary study objectives

Best-Corrected Visual Acuity (BCVA)

Compliance with Face Down Positioning

Complication Rates

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met