A Prospective, Open-label, Multicenter Clinical Follow-up Investigation of the ARGOS-01 and ARGOS-02 Patients to Assess the Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)
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-IO system in patients with Primary Open Angle Glaucoma (POAG)
详细描述
This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients.
From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study.
Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.
排除标准
- 未提供
结局指标
主要结局
Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)
时间窗: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time.
Performance: Level of Agreement Between GAT and the ARGOS-IO System
时间窗: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-IO system (IOP in mmHg) following the Bland-Altman method.
Performance: Device Malfunctions
时间窗: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs)
次要结局
- Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)(Baseline visit to Day 1080 (V01 [Baseline visit] to V07))
- Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)(Baseline visit to Day 1080 (V01 [Baseline visit] to V07))