N/A
N=16
Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
Primary Open-angle Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT03651336 ↗Enrolled (actual)
16
Serious AEs
62.5%
Results posted
May 2025
Primary outcome: Primary: Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE) — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ARGOS-IO Sensor Pressure System (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Implandata Ophthalmic Products GmbH
- Primary completion
- Apr 2022
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 | — |
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)
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.