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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

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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

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor

196 Previous Clinical Trials

25,504 Total Patients Enrolled

Varun Chaudhary, MD, FRCSCPrincipal InvestigatorMcMaster University, St. Joseph's Hospital

1 Previous Clinical Trials

70 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of inclusion for this clinical trial?

"Correct, according to the information on clinicaltrials.gov, this investigation is presently seeking participants. It was first posted on November 21st 2023 and has since been updated once more with a current search for 40 individuals at one location."

Answered by AI

Is enrollment in this experiment available to individuals at the current time?

"This clinical trial is still looking for participants. On November 21st of this year, the information hosted on clinicaltrials.gov was modified to reflect that details pertaining to the study are up-to-date."

Answered by AI

What is the ultimate objective of this medical experiment?

"This clinical trial's primary outcome to be evaluated over its period is Patient Retention Rate. Secondary objectives include evaluating the Compliance with Face Down Positioning (through self-administered questionnaires that score between 1 and 10, higher scores indicating better compliance), Macular Hole Closure Rate (evaluated by two independent readers masked to treatment allocation) and Best-Corrected Visual Acuity (measured through Snellen visual acuity ranging from 20/10 at best to 20/1000 at worst)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Varun Chaudhary 2023. "Duration of Face Down Positioning for Full-Thickness Macular Hole Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06000111.