The Explore Study for the Efficacy and Safety of Multi-electrocoagulation Retinectomy in the Treatment of Retinal Re-detachment in Silicone Oil Filled Eye
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- retina reattachment rate
研究概览
简要总结
Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a complex retinal detachment with poor prognosis.
In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation retinectomy to reattach the retina. Here the investigators aimed to explore the safety and efficacy of this new surgical approach
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.
In this study, we try to apply a modified surgery named Multi-electrocoagulation retinectomy to re-attach the retina.
Instead of cutting through the proliferated retina directly, this new surgical approach adopts to cut the retina apart in a honeycomb shape with the help of electrocoagulation.
In this way, we not only relax the traction of the proliferative membranes, but also reserve the rest retina to cover the RPE layers.
Based on the hypothesis above, we are aiming to explore the safety and efficacy of this new surgical approach
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-60 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
- •The primary retinal detachment was not caused by ocular trauma.
- •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
retina reattachment rate
时间窗: 3 months after the surgery
次要结局
- The degree of recurrent PVR(Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.)
- The incidence of intraocular hemorrhage(Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.)
- visual acuity(Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.)
- Intraocular pressure(Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.)
研究者
Xiaofeng Lin
vice-president
Sun Yat-sen University