NCT01097174已完成不适用
A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 555
- 试验地点
- 14
- 主要终点
- Incidence of intraoperative and postoperative adverse events
研究概览
简要总结
This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OAG
- •IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)
排除标准
- •Acute angle closure, narrow angle, uveitic or neovascular glaucoma
- •Normal tension glaucoma
结局指标
主要结局
Incidence of intraoperative and postoperative adverse events
时间窗: Day 0 - Year 3
次要结局
- Intraocular pressure (IOP) reduction(1 - 36 months postoperatively)
- Ocular hypotensive medication use(1 - 36 months postoperatively)
研究者
研究点 (14)
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