A Randomised Controlled Trial to Evaluate the Effect of Face-down Posturing on Retinal Displacement and Distortion Following Retinal Detachment Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 主要终点
- To assess the proportion of patients in each treatment group with retinal displacement at 26 weeks after surgery
研究概览
简要总结
A randomised controlled trial to evaluate the effect of face-down posturing on retinal displacement and distortion following retinal detachment repair.
详细描述
During the surgical repair of a retina detachment, a gas bubble is inserted into the eye to keep the retina flat. Following this, it is common to ask patients to adopt a certain head position for a set period of time after their operation. This is known as posturing. It is thought that by adopting a certain head position/posturing, the bubble aids re-attachment of the retina. However, when the retinal detachment involves the macula (central portion of the retina) it has been shown that the retina can shift (or displace) post-operatively, leading to distortion in the patient's vision.
The purpose of this study is to investigate whether adopting different head positions following surgery for macula involving retinal detachments, can reduce retinal displacement and visual distortion. The investigators plan to recruit 368 patients. Patients will be in follow up for a period of six months. The study will be operational at two different hospitals in the United Kingdom.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Fovea-involving rhegmatogenous retinal detachment
- •History of central visual loss within the past 14 days
- •Patients undergoing vitrectomy and gas surgery, under local anaesthetic
- •Able to give informed consent
- •18 years old and over
排除标准
- •Previous vitrectomy or cryo-buckle surgery
- •Retinal detachment surgery requiring silicone oil tamponade
- •Existing ophthalmic condition which limits the patient's visual acuity (BCVA 6/36 or worse)
- •Inability to posture post-operatively or commit to follow-up visits
结局指标
主要结局
To assess the proportion of patients in each treatment group with retinal displacement at 26 weeks after surgery
时间窗: 26 Weeks
The proportion of patients in each treatment group with retinal displacement at 26 weeks after surgery
次要结局
- To assess the degree of retinal displacement on autofluorescence imaging(26 Weeks)
- To report the mean (SD) / median (IQR) Visual function score as measured using the Visual Function Questionnaire(26 Weeks)
- To assess proportion of patients in each group with retinal displacement at 8 weeks(Eight weeks)
- To report the mean (SD)/median (IQR) ETDRS visual acuity score at two different time-points(Eight and 26 weeks)
- To report the mean(SD)/median(IQR) Objective distortion score at two different time-points(Eight and 26 weeks)