Foldable Capsular Vitreous Body Implantation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Intra-ocular pressure
研究概览
简要总结
This study is intended to evaluate the clinical usefulness of the FCVB in its on-label use, but in a different racial type than studies till now (Asians only). The device will be inserted in Caucasian patients with permanent loss of functional vision (visual acuity hand movements or less), where a permanent use of repeat silicone oil is required to maintain the eye pressure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18
- •Axial length between 16 and 28 mm (according the guidelines from the manufacturer)
- •Loss of functional vision in study eye
- •Visual acuity of 0.4 or better in fellow eye
- •Requirement of (repeated) long-term silicone oil tamponade to maintain eye pressure and keep the retina attached
排除标准
- •Visual acuity beyond 0.4 in non-study eye
- •Severe general disease that is evaluated to impact live expectancy beyond the duration of the study follow-up (3 years)
- •Retinal detachment under silicone oil fill
- •Patients with a silica gel allergy or scar diathesis
- •Patients with serious heart, lung, liver, or kidney dysfunction
- •Patients with proliferative diabetic retinopathy, endophthalmia, uveitis and other uncontrollable eye diseases, or a contralateral eye that had intraocular retinal surgery
- •Patients with history of drug abuse or alcoholism
- •Patients are had participating in other drug or medical device clinical trials before screening for this trial
- •Pregnancy, preparation for pregnancy during clinical trial, or breast-feeding
- •Belief by any of the research doctors that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression
研究组 & 干预措施
FCVB Implant
All subjects in this study are in the experimental treatment arm and will receive the FCVB implant
干预措施: Foldable Capsular Vitreous Body Implant (Device)
结局指标
主要结局
Intra-ocular pressure
时间窗: 3 years
Evaluation of the device as long-term solution for maintenance the intra-ocular pressure, potentially reducing the number of surgeries (silicone oil exchanges) for the patient
次要结局
未报告次要终点
研究者
Prof. Dr. Peter Stalmans
Head of Clinic
Universitaire Ziekenhuizen KU Leuven