NCT00326040已完成4 期
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma subjects.
详细描述
Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Diagnosed with primary open-angle glaucoma (POAG)
- •Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
- •Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)
排除标准
- •Angle closure glaucoma
- •Fellow eye already enrolled
研究组 & 干预措施
A
Experimental
干预措施: Glaucoma Surgery (Device)
结局指标
主要结局
Efficacy
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (7)
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