An Observational Multicenter Clinical Study to Assess the Long-Term Safety of the CyPass Micro-Stent in Patients With Primary Open Angle Glaucoma Who Have Completed Participation in the COMPASS Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 22
- 主要终点
- 5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.
详细描述
The COMPASS Trial (TMI-09-01) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the CyPass Micro-Stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. In the study, 505 subjects were randomized to either the CyPass group, who underwent cataract surgery and received the CyPass Micro-Stent, or the Control group, who underwent cataract surgery alone. All subjects randomized were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study.
The COMPASS-XT (TMI-09-01-E) Trial is designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data will be collected at 36 months, 48 months, and 60 months postoperatively for a total of 5 year follow-up across the 2 studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the COMPASS Trial
- •Understands study requirements and is willing to follow study instructions and return for study visits
排除标准
- •Systemic disease that would put subject health at risk and/or prevent completion of required study visits.
- •Early termination from the COMPASS Trial.
研究组 & 干预措施
Cataract Surgery + CyPass
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
干预措施: Cataract Surgery (Procedure)
Cataract Surgery Only
Cataract Surgery (COMPASS trial) with no CyPass Micro-Stent implantation
干预措施: Cataract Surgery (Procedure)
Cataract Surgery + CyPass
CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
干预措施: CyPass Micro-Stent (Device)
结局指标
主要结局
5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group
时间窗: Up to Month 60 postoperative
Sight-threatening adverse events occurring in the study eye included, but were not limited to: BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection. The number of events at the end of Year 5 was divided by the number of eyes at risk at the beginning of Year 1 for a 5-year annualized rate. The 5-year annualized rate is reported as a percentage, with the last annual non-censored rate divided by 5. Inferential testing was not planned for this endpoint.
次要结局
- Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells(Month 36, 48, 60 postoperative)
- Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion(Month 36, 48, 60 postoperative)
- Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations(Month 36, 48, 60 postoperative)
- Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion(Month 36, 48, 60 postoperative)
- Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only(Month 36, 48, 60 postoperative)
- Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity(Month 36, 48, 60 postoperative)
- Change From Month 24 in Central Corneal Thickness(Month 24, 36, 48, 60 postoperative)
- Number of Subjects With CyPass Device Malposition, Dislodgement or Movement(Up to 60 months postoperatively)
- Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit(Baseline, Month 12, 24, 36, 48, 60 postoperative)
- Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye(Up to Month 60 postoperative)
- Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema(Month 36, 48, 60 postoperative)
- Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare(Month 36, 48, 60 postoperative)
- Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking(Month 36, 48, 60 postoperative)
- Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis(Month 36, 48, 60 postoperative)
- Change From Month 24 in Visual Field Mean Deviation(Month 24, 36, 48, 60 postoperative)
- Central Corneal Endothelial Cell Density (ECD) by Visit(Baseline, Month 3, 6, 12, 24, 36, 48, 60 postoperative)
- Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg(Month 36, 48, 60 postoperative)
- Mean Reduction From Baseline in Intraocular Pressure (IOP)(Baseline, Month 36, 48, 60 postoperative)
- Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications(Baseline, Month 36, 48, 60 postoperative)