Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study
St. Joseph's Healthcare Hamilton
40 participants
Nov 21, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria7
- 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
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Interventions
Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06000111