A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 975
- 试验地点
- 69
- 主要终点
- Intraocular pressure decrease
研究概览
简要总结
Evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
详细描述
This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects 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
盲法说明
Person(s) checking intraocular pressures are masked, except for day of surgery, throughout the duration of the trial.
入排标准
- 年龄范围
- 46 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 46 years of age or older
- •A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery
- •Pseudophakic with prior uncomplicated cataract surgery
排除标准
- •Angle closure, congenital, or secondary glaucoma
- •Diagnosed degenerative visual disorders
- •Clinically significant intraocular inflammation or infection
结局指标
主要结局
Intraocular pressure decrease
时间窗: 24 months
Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.
Intraocular pressure decrease (outcome 2)
时间窗: 24 months
Change from baseline in mean unmedicated diurnal IOP at Month 24.
次要结局
未报告次要终点