NCT01252914已完成4 期
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean diurnal Intraocular Pressure 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 assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
详细描述
The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
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)
- •Subjects 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
One iStent Supra Stent and medication
Experimental
The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma
干预措施: iStent Supra Stent (Device)
结局指标
主要结局
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
时间窗: 12 months
次要结局
- Mean diurnal Intraocular Pressure < 18 mmHg at month 12(12 months)
研究者
研究点 (1)
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