Follow-up of the First in Man, Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery (Follow-up Month 12 - Month 36)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 10
- 主要终点
- Performance: Level of Agreement Between GAT and the ARGOS-SC System
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
详细描述
This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01_FU study.
The sensor was always implanted in one eye only which will be the study eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.
排除标准
- 未提供
结局指标
主要结局
Performance: Level of Agreement Between GAT and the ARGOS-SC System
时间窗: Day 360 to Day 1080 (V09 to V13)
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.
次要结局
- Safety: Number of Patients Experiencing a Device-related SAE (SADE)(Day 360 to Day 1080 (V09 to V13))
- Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)(Day 360 to Day 1080 (V09 to V13))
- Performance: Percentage of Measurements Within +/- 5 mmHg(Day 360 to Day 1080 (V09 to V13))
- Performance: Device Malfunctions(Day 360 to Day 1080 (V09 to V13))
- Usability: User Acceptance at the Investigational Site(Day 1080 (V13))
- Usability: User Acceptance at Home(Day 1080 (V13))