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

Официальное название

Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study

Обзор

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.

Вмешательства

• Поведенческое 3 Days of face-down positioning
  Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
• Поведенческое 7 Days of face-down positioning
  Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.

Первичные конечные точки

• Recruitment Rate [Срок оценки: The recruitment rate will be calculated during the recruitment period.]
• Retention Rate [Срок оценки: The retention rate will be calculated at 3-months post-operatively.]
• Completion Rate [Срок оценки: The completion rate will be calculated at 3-months post-operatively.]
• Recruitment Time [Срок оценки: The recruitment time will be calculated during the recruitment period.]

Вторичные конечные точки (6)

• Macular Hole Closure Rate [Срок оценки: 3-months post-operatively]
• Best-Corrected Visual Acuity (BCVA) [Срок оценки: 3-months post-operatively]
• Vision specific quality of life measure [Срок оценки: 3-months post-operatively]
• Compliance with Face Down Positioning [Срок оценки: While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.]
• Complication Rates [Срок оценки: Rates will be determined for the entire follow-up period (3-months)]
• Health Related Quality of Life Measure [Срок оценки: 3-months post-operatively]

Критерии участия

Критерии включения

• Consecutive patients with an idiopathic full-thickness macular hole
• Symptom duration of less than 6 months
• Patient must agree to participate in this investigation

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• St. Joseph's Hospital King Campus — Stoney Creek

Публикации

• Nanji K, Oquendo PL, Srinivasan S, Vyas C, Prasad F, Farrokhyar F, Chaudhary V. Duration of face down positioning following full-thickness macular hole repair: A protocol for a randomized pilot study. PLoS One. 2024 Aug 20;19(8):e0304566. doi: 10.1371/journal.pone.0304566. eCollection 2024. PMID 39163327

Идентификаторы

NCT: NCT06000111 · 16100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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