NCT01252862已完成4 期
A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline
研究概览
简要总结
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma
详细描述
This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects
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
- 是
入选标准
- •Diagnosed with primary open-angle glaucoma (POAG)
- •Subject on one topical hypotensive medication
排除标准
- •Traumatic, uveitic, neovascular, or angle closure glaucoma
- •Fellow eye already enrolled
研究组 & 干预措施
Two iStents devices
Experimental
Two iStents devices will be implanted
干预措施: iStent (Device)
结局指标
主要结局
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline
时间窗: 12 Months
次要结局
- IOP < 18 mm Hg at Month 12(12 months)
研究者
研究点 (1)
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