CompletedNot Applicable

Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

Germany16 participantsStarted 2018-08-15

Plain-language 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)

Who can participate

Age range40 Years

SexALL

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Inclusion Criteria: * Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor. Exclusion Criteria: * N/A

What they're measuring

Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)

Timeframe: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Performance: Level of Agreement Between GAT and the ARGOS-IO System

Timeframe: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Performance: Device Malfunctions

Timeframe: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Trial details

NCT IDNCT03651336

SponsorImplandata Ophthalmic Products GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-27

Results submitted2025-03-20

View on ClinicalTrials.gov More Primary Open-angle Glaucoma trials