The Multi-center Exploratory Clinical Trials for the Evaluation of Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 122
- 试验地点
- 9
- 主要终点
- Complete retinal reattach rate at the 52 weeks after implantation of the FCVB
研究概览
简要总结
The purpose of this study is to determine the feasibility, primary safety and efficacy of foldable capsular vitreous body (FCVB) in the treatment of retinal detachment, based on the multi-center clinical trial.
详细描述
Previous clinical trial have demonstrated that foldable artificial vitreous body (FCVB),with balanced salt solution (BSS) filled in 11 patients during three-months observation,or silicone oil filled in 4 patients during a six-month observation respectively, can be transplanted into the vitreous body easily, and performances good safety and efficacy in the treatment of severe retinal detachment.
Current multi-center clinical trial was to determine the feasibility, primary safety and efficacy of FCVB with silicone oil filled in the treatment of retinal detachment in 120 patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range from 18 to 65, Refractive error less than ±3D
- •Corrected visual acuity less than 0.05
- •ocular axial length is 16 to 25mm
- •severe retinal detachment that can not be treated by current artificial vitreous body:
- •Severe unilateral ocular perforating injuries, compounded retinal or choroidal detachments resulted from retinal rupture or retinal choroidal hemorrhage.
- •Severe unilateral ocular rupture injuries result in retina or choroid defect.
- •Giant posterior scleral rupture injuries that can not be repaired.
- •Silicone oil can't be taken out for a long time with incomplete reattachment.
- •Participants have undergone retinal detachment surgery and silicone oil tamponade twice or more, however, retina is re-detachment after silicone oil removal.
- •Participants can understand the aim of this clinical trial and sign the informed consent form
排除标准
- •Participants have a silica gel allergy or scar diathesis
- •entophthalmia
- •The contralateral eye suffered from intraocular surgery
- •uncontrollable the other eye diseases
- •Corrected visual acuity of contralateral eye less than 0.4
- •Proliferative diabetic retinopathy
- •the lens of target eye is transparent
- •Serious heart, lung, liver and kidney dysfunction
- •pregnancy, preparation for pregnancy during clinical trial and breast-feeding female
- •drug abuse or alcoholism
- •participated the other drug or medical devices clinical trial before screening of this trial
- •Any research doctors consider that the condition of participants will hinder the clinical trial--Prone to mental stress, loss control of mood, depression etc.
- •Patient adherence is so poor that study procedures can not be finished
研究组 & 干预措施
FCVB team
the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)
干预措施: foldable capsular vitreous body(FCVB) (Device)
结局指标
主要结局
Complete retinal reattach rate at the 52 weeks after implantation of the FCVB
时间窗: 52 weeks after implantation of the FCVB
次要结局
- Retinal reattach rate, Visual function，and Silicone oil change(Before surgery, 3days,1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks after FCVB implantation surgery (If patients ask for the delay of removal of FCVB, the patients must received a review every three months))