Non Randomised Multi-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ciliatech
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Assess post-op IOP clinical success
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy
详细描述
68 patients will be included in this 5 years interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of an interposition supraciliary permanent device.
Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.
Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.
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
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of POAG Schafer 3 or 4
- •Medicated IOP ≥ 21
排除标准
- •Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
- •Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, ...)
- •Medical treatment having intraocular hypotensive effect
结局指标
主要结局
Assess post-op IOP clinical success
时间窗: 6 months
Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg
Assess post-op IOP reduction
时间窗: 6 months
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
次要结局
未报告次要终点