An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.
研究概览
简要总结
This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument. Patients are consented prior to surgery and followed for 12 months postoperatively. Data regarding IOP, use of glaucoma medications, and any device-related complications are collected during the study time period.
详细描述
This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed.
Data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.
Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary open angle glaucoma
- •Goniotomy surgery performed using the C-Rex Instrument
排除标准
- •History of intraocular surgery within 8 weeks prior to C-Rex surgery
- •Preoperative IOP higher than 33 mmHg
- •Presence of a glaucoma type other than POAG
- •Presence of clinically significant intraocular pathology other than cataract or glaucoma
结局指标
主要结局
Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.
时间窗: 12 month postoperative
Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery.
次要结局
未报告次要终点