NCT06057051招募中不适用
A Prospective, Multicenter Study of the Glaukos® iStent Infinite Trabecular Micro-Bypass System Model iS3 in Subjects With Mild to Moderate Primary Open-angle Glaucoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline
研究概览
简要总结
Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary open-angle glaucoma
- •Phakic or pseudophakic
- •Age 35 years or older
排除标准
- •Traumatic, uveitic, neovascular, angle-closure glaucoma or
- •glaucoma associated with vascular disorders
- •Active corneal inflammation or edema
- •Retinal disorders not associated with glaucoma
研究组 & 干预措施
iStent Infinite
Experimental
iStent Infinite Trabecular Micro-Bypass System
干预措施: iStent Infinite (Device)
结局指标
主要结局
Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline
时间窗: 12 Months
次要结局
未报告次要终点
研究者
研究点 (1)
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