NCT01252849已完成不适用
A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 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 safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 two topical hypotensive medications
排除标准
- •Traumatic, uveitic, neovascular, or angle closure glaucoma
- •Fellow eye already enrolled
研究组 & 干预措施
First Arm: One iStent, medication
Experimental
Device: One iStent, medication
干预措施: iStent (Device)
Second Arm: Two iStents, medication
Experimental
Device: Two iStent devices, medication
干预措施: iStent (Device)
Third Arm: Three iStents, medication
Experimental
Device: Three iStent devices, medication
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
- Mean diurnal IOP <18 mmHg at month 12(12 months)
研究者
研究点 (1)
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