NCT06000111 Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
| NCT ID | NCT06000111 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Joseph's Healthcare Hamilton |
| Condition | Macular Holes |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2025-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-11-21 with a primary completion date of 2025-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Varun Chaudhary, MD, FRCSC
PRINCIPAL INVESTIGATOR
McMaster University, St. Joseph's Hospital
Frequently Asked Questions
Who can join the NCT06000111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Macular Holes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06000111 currently recruiting?
Yes, NCT06000111 is actively recruiting participants. Contact the research team at vchaudh@mcmaster.ca for enrollment information.
Where is the NCT06000111 trial being conducted?
This trial is being conducted at Stoney Creek, Canada.
Who is sponsoring the NCT06000111 clinical trial?
NCT06000111 is sponsored by St. Joseph's Healthcare Hamilton. The principal investigator is Varun Chaudhary, MD, FRCSC at McMaster University, St. Joseph's Hospital. The trial plans to enroll 40 participants.