Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Retention Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The surgeon will be masked to the patient's treatment allocation until after surgery is complete. At this point, the surgeon will be made aware of the patient's treatment allocation and inform the patient in the recovery room regarding their treatment allocation. The participants and the clinical teams managing the patient care will be unmasked. The outcome assessors will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with an idiopathic full-thickness macular hole
- •Symptom duration of less than 6 months
- •Patient must agree to participate in this investigation
排除标准
- •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
结局指标
主要结局
Retention Rate
时间窗: The retention rate will be calculated at 3-months post-operatively.
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.
Completion Rate
时间窗: The completion rate will be calculated at 3-months post-operatively.
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.
Recruitment Rate
时间窗: The recruitment rate will be calculated during the recruitment period.
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.
Recruitment Time
时间窗: The recruitment time will be calculated during the recruitment period.
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.
次要结局
- Complication Rates(Rates will be determined for the entire follow-up period (3-months))
- Best-Corrected Visual Acuity (BCVA)(3-months post-operatively)
- Health Related Quality of Life Measure(3-months post-operatively)
- Compliance with Face Down Positioning(While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.)
- Macular Hole Closure Rate(3-months post-operatively)
- Vision specific quality of life measure(3-months post-operatively)
研究者
Varun Chaudhary
Professor, Department of Surgery, Chief of Ophthalmology, Hamilton Regional Eye Institute
St. Joseph's Healthcare Hamilton