N/A
Completed N=16
Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
Source: ClinicalTrials.gov NCT03651336 ↗Enrolled (actual)
16
Serious AEs
62.5%
Results posted
May 2025
Primary outcomePrimary: Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE) — 0; 0 Participants
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE) |
0; 0 | — |
| PRIMARY Performance: Level of Agreement Between GAT and the ARGOS-IO System |
1.4 | — |
| PRIMARY Performance: Device Malfunctions |
8; 0 | — |
| SECONDARY Patient's Compliance in IOP Self-monitoring (Daily Self-measurements) |
79 | — |
| SECONDARY Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day) |
3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT03651336). 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.