Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of POAG
- •Medicated IOP ≥ 21 and ≤ 35 mmHg
- •Use of 1 - 4 topical IOP lowering medications
排除标准
- •Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- •Use of oral hypotensive medication treatment for glaucoma
- •Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
- •Clinically significant ocular pathology other than POAG
研究组 & 干预措施
CyPass Micro-Stent
Subjects receive the CyPass Micro-Stent
干预措施: CyPass Micro-Stent (Device)
结局指标
主要结局
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline
时间窗: Baseline; Month 12 postoperative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.
次要结局
- Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication(Month 12 postoperative)
- Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline(Baseline, Month 12 postoperative)