Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 328
- 试验地点
- 3
- 主要终点
- retinal reattachment
研究概览
简要总结
Previous pilot study has demonstrated that the novel multi-endodiathermy retinectomy is feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled eyes of adults over a 3-month observation.
Here, the investigators conduct this randomized and multicenter clinical trial to compare the efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.
详细描述
The relaxing retinectomy is a useful surgery for retinal re-detachment in eyes with silicone oil filled. However, it has some obvious disadvantages such as the cut of the normal retina surrounding, leaving a large area of retinal deficiency and significant exposure of retinal pigment epithelium and choroid membranes.
We proposed a novel multi-endodiathermy retinectomy as a potential surgery. A pilot study has demonstrated that the novel multi-endodiathermy retinectomy is feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled eyes of adults over a 3-month observation.
Here, the investigators conduct this randomized and multicenter clinical trial to compare the efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.
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
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years, male or female;
- •The primary retinal detachment was caused by ocular trauma, and the vitreous body is filled with silicone oil now;
- •The presence of inferior retinal re-detachment located among 3-9 o'clock.
排除标准
- •Location of the re-detached retina is not mainly in the inferior of the eye;
- •The fundus is unobservable because of severe corneal opacity;
- •The contralateral eye is non-functional;
- •Serious heart, lung, liver and kidney dysfunction.
结局指标
主要结局
retinal reattachment
时间窗: 3 months after retinectomy
次要结局
- visual acuity(1 day before surgery; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after retinectomy; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after silicone oil removal.)
- degree of recurrent PVR(1 day before surgery; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after retinectomy; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after silicone oil removal.)
- operative duration(from the end of former silicone oil removal to the end of the new silicone oil fill)
- intraocular pressure(1 day before surgery; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after retinectomy; 3 days, 1 week, 2 weeks, 4 weeks and 3 months after silicone oil removal.)
- the incidence of intraocular hemorrhage(during retinectomy)
研究者
Xiaofeng Lin
vice-president
Sun Yat-sen University