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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 5
- Primary Endpoint
- Performance: Level of Agreement Between GAT and the ARGOS-SC System
Study Overview
Brief Summary
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.
Exclusion Criteria
- Not provided
Arms & Interventions
ARGOS-SC Sensor
The ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study.
Intervention: ARGOS-SC suprachoroidal pressure sensor (Device)
Outcomes
Primary Outcomes
Performance: Level of Agreement Between GAT and the ARGOS-SC System
Time Frame: 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.
Secondary Outcomes
- 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))