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

RecruitingNAAges 18 Years - anyAllSt. Joseph's Healthcare Hamilton
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ฮผm * 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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What it tests

  • 3 Days of face-down positioning
  • 7 Days of face-down positioning
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Where

1 site
St. Joseph's Hospital King Campus
Stoney Creek, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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