An Observational Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen™ Micro-Interventional Cyclodialysis System Procedures in Patients 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
- 300
- 试验地点
- 32
- 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 observational study will enroll adults with open angle glaucoma (OAG) who had surgery to reduce intraocular pressure (IOP) using the CycloPen Micro-Interventional System. Consenting participants will be followed for 24 months after their surgery.
Data regarding IOP, use of glaucoma medications, and any side effects related to the surgery will be collected from participants' preoperative examination, their surgery, and postoperative examinations.
详细描述
This is a multicenter, observational registry of eligible adults with open angle glaucoma (OAG) in whom IOP-lowering surgery with the CycloPen Micro-Interventional System was performed are consecutively enrolled.
Data will be collected from the preoperative visit(s) that directly preceded surgery, the surgical procedure, and postoperative visits through 24 months after CycloPen System use.
Specific data to be collected includes details of the CycloPen surgical procedure, IOP, use of ocular hypotensive medications, and any side effects related to the surgery.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included, participants must have:
- •Open angle glaucoma
- •IOP-lowering surgical procedure using the CycloPen System
- •There are no exclusionary criteria.
排除标准
- 未提供
研究组 & 干预措施
CycloPen Cyclodialysis System in conjunction with cataract surgery
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery
干预措施: CycloPen Cyclodialysis System (Device)
CycloPen Cyclodialysis System in standalone surgery
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System
干预措施: CycloPen Cyclodialysis System (Device)
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 months 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