Randomized, Prospective Clinical Evaluation of the Safety and Effectiveness of Visco-Assisted CyPass® Implantation in Patients With Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 6
- 主要终点
- Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).
详细描述
The study was conducted in 2 phases. Only one eye per subject was treated for each independent phase.
Dose Selection Phase (Cohort 1): Subjects were randomized in a 1:1:1 ratio and implanted with either a CyPass Micro-Stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a CyPass Micro-Stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a CyPass Micro-Stent without adjunct viscoelastic in the study eye.
Expansion Phase (Cohort 2): Subjects were randomized in a 1:1 ratio and implanted with either the CyPass Micro-Stent without adjunct viscoelastic or the CyPass Micro-Stent with 60 μl of ophthalmic viscoelastic (based on Dose Selection results). Subjects were randomized to treatment on the day of their surgical procedure. A total of 9 scheduled visits were planned including Screening (Day -45 to -2), Baseline (Day -15 to -1), Surgery (Day 0), 1 Day (Day 1), 1 Week (Day 5-9), 1 Month (Day 21-35), 3 Month (Day 70-98), 6 Month (Day 150-210), and 12 Month (Day 330-420) visits. The total expected duration of participation for each subject was up to 13 months.
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
- None
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
- •Diagnosis of open angle glaucoma;
- •Unmedicated IOP between 21 - 36 mmHg, inclusive;
- •Normal angle anatomy at site of intended CyPass Micro-Stent implantation.
排除标准
- •Advanced glaucoma;
- •Prior incisional glaucoma surgery;
- •Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma;
- •Clinically significant ocular pathology other than glaucoma.
研究组 & 干预措施
CyPass60
CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
干预措施: Viscoelastic (Device)
CyPass
CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye
干预措施: CyPass Micro-Stent (Device)
CyPass30
CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
干预措施: CyPass Micro-Stent (Device)
CyPass30
CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
干预措施: Viscoelastic (Device)
CyPass60
CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
干预措施: CyPass Micro-Stent (Device)
结局指标
主要结局
Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication
时间窗: Baseline (Day -1), Month 12 PostOperative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
次要结局
- Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months(Month 12 PostOperative)
- Mean Change From Baseline to 12 Months Postoperative in Medicated IOP(Baseline (Day -1), Month 12 PostOperative)
- Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used(Screening (Day -2), Month 12 PostOperative)
- Percentage of Subjects With Device-related Ocular Adverse Events(Up to Month 12 PostOperative)