Actively Recruiting
Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
Led by St. Joseph's Healthcare Hamilton · Updated on 2024-11-29
40
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consecutive patients with an idiopathic full-thickness macular hole
- Symptom duration of less than 6 months
- Patient must agree to participate in this investigation
You will not qualify if you...
- Macular hole minimum diameter greater than 1000 bcm
- A history of high myopia (greater than -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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Joseph's Hospital King Campus
Stoney Creek, Ontario, Canada, L8G 5E4
Actively Recruiting
Research Team
V
Varun Chaudhary, MD, FRCSC
CONTACT
K
Keean Nanji, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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