NCT01517477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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Mean diurnal intraocular pressure (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 intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.
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
结局指标
主要结局
Mean diurnal intraocular pressure (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 (2)
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