NCT05280366进行中（未招募）不适用
A Prospective, Randomized, Multi-center Evaluation of the Safety and Effectiveness of the STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 20
- 主要终点
- Change in mean unmedicated diurnal Intraocular Pressure (IOP)
研究概览
简要总结
A study of the Streamline Surgical System versus competitor
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Mild to Moderate Primary Open Angle Glaucomma
排除标准
- •Other types of glaucoma including but not limited to: Normal tension glaucoma, pseudoexfoliative glaucoma, narrow angle glaucoma, traumatic, congenital, malignant, uveitic or neovascular glaucoma. Ocular hypertension.
研究组 & 干预措施
Streamline Surgical System
Other
Streamline Surgical System procedure administered
干预措施: Streamline Surgical System (Device)
iStent Inject W
Active Comparator
iStent Inject W implanted
干预措施: iStent Inject W (Device)
结局指标
主要结局
Change in mean unmedicated diurnal Intraocular Pressure (IOP)
时间窗: 24 months
Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time
次要结局
未报告次要终点
研究者
研究点 (20)
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