NCT01444040已完成4 期
A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Ophthalmic Solution 0.004%
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
研究概览
简要总结
Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
详细描述
Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
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
- 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
- 否
入选标准
- •Phakic study eye
- •IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement
排除标准
- •Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
- •Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma
研究组 & 干预措施
Drug
Active Comparator
Travoprost drops
干预措施: Travoprost (Drug)
iStent inject
Active Comparator
Implantation of two iStent inject devices
干预措施: iStent inject (Device)
结局指标
主要结局
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
时间窗: 12 months
次要结局
- Change in mean diurnal IOP vs. screening(Month 24)
- Change in screening in time-wise IOPs(Various Month 12-60)
- Proportion of responders(Various 12-60 months)
研究者
研究点 (1)
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