A Randomised Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment; Anatomical Success, Functional Success and Impact on Patient Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this research study is to compare the outcomes of pneumatic retinopexy with the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal detachment, in terms of anatomical success, functional success and impact on patient quality of life.
详细描述
Rhegmatogenous retinal detachment (RRD)is an acute, sight threatening condition, with an incidence of approximately 10 per 100,000 population. Both of the treatments under investigation are widely used and accepted by vitreoretinal surgeons, but randomised, prospective comparison of the two techniques has not been reported in the scientific literature to date. Currently, the management decisions surrounding primary retinal detachment are grounded on a weak evidence base. The findings of this study will allow vitreoretinal surgeons and their patients to select the most appropriate intervention for that individual, in an informed and holistic manner.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with acute rhegmatogenous retinal detachment
- •Single retinal break OR group of breaks no larger than one clock hour (30°)
- •All break/s in detached retina between 8-4 o'clock
- •No significant proliferative vitreoretinopathy
排除标准
- •Inferior breaks in detached retina
- •Inability to read English language
- •Age < 18 years
- •Mental incapacity
- •Previous vitrectomy (index eye)
- •Previous retinal detachment (index eye)
- •Inability to maintain the post-operative posturing
- •Inability to carry out detailed examination of peripheral retina due to media opacity
研究组 & 干预措施
Vitrectomy
干预措施: Vitrectomy (Procedure)
Pneumatic retinopexy
干预措施: Pneumatic retinopexy (Procedure)
结局指标
主要结局
Visual acuity
时间窗: 12 months post intervention
次要结局
- Visual acuity(1 week, 1 month, 3 months and 6 months post intervention)
- Subjective visual function(3, 6 and 12 months post intervention)
- Anatomical success (complete retinal re-attachment)(3, 6 and 12 months post intervention)
- Subjective health related quality of life(Baseline and 1 month post intervention)