N/A
Completed N=22
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
Source: ClinicalTrials.gov NCT04773106 ↗Enrolled (actual)
22
Serious AEs
31.8%
Results posted
May 2025
Primary outcomePrimary: Performance: Level of Agreement Between GAT and the ARGOS-SC System — -0.3 mmHg
Summary
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance: Level of Agreement Between GAT and the ARGOS-SC System |
-0.3 | — |
| SECONDARY Safety: Number of Patients Experiencing a Device-related SAE (SADE) |
— | — |
| SECONDARY Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs) |
50; 15; 1; 1; 7 | — |
| SECONDARY Performance: Percentage of Measurements Within +/- 5 mmHg |
94 | — |
| SECONDARY Performance: Device Malfunctions |
13 | — |
| SECONDARY Usability: User Acceptance at the Investigational Site |
4.7 | — |
| SECONDARY Usability: User Acceptance at Home |
5.6 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT04773106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.