Comparing face-down positioning durations after macular hole surgery
Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study
This study is testing whether sitting face-down for 3 days or 7 days after macular hole surgery helps people heal better and see clearly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Joseph's Healthcare Hamilton Academic / other |
| Locations | 1 site (Stoney Creek, Ontario) |
| Trial ID | NCT06000111 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal duration of face-down positioning required after surgical repair of full-thickness macular holes. It randomly assigns participants to either 3 days or 7 days of face-down positioning following pars plana vitrectomy. The study aims to assess key outcomes such as macular hole closure rates, visual acuity, quality of life, patient compliance, and complication rates. This feasibility study will provide valuable insights for a future larger clinical trial.
Who should consider this trial
Good fit: Ideal candidates are patients with an idiopathic full-thickness macular hole and symptom duration of less than 6 months.
Not a fit: Patients with a macular hole diameter greater than 1000 μm or those with a history of high myopia or other specified eye conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the minimum required recovery time for patients, potentially improving comfort and compliance.
How similar studies have performed: While this approach is novel in its specific comparison of positioning durations, similar studies on post-surgical positioning have shown varying success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stoney Creek, Ontario
- St. Joseph's Hospital King Campus — Stoney Creek, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Varun Chaudhary, MD, FRCSC — McMaster University, St. Joseph's Hospital
- Study coordinator: Varun Chaudhary, MD, FRCSC
- Email: vchaudh@mcmaster.ca
- Phone: 905-573-7777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.