NCT01455467已完成不适用
A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
研究概览
简要总结
Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.
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
- 否
入选标准
- •Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
- •Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
排除标准
- •Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
- •Prior stent implantations (study eye)
结局指标
主要结局
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
时间窗: 12 Months
次要结局
未报告次要终点
研究者
研究点 (2)
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