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

Not Applicable

Completed

• Conditions: Primary Open-angle Glaucoma

• Registration Number: NCT03651336
• Lead Sponsor: Implandata Ophthalmic Products GmbH

Brief 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)

Detailed Description

This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients.

From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study.

Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this study.

The sensor was always implanted in one eye only which will be the study eye.

Study Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-29
• Primary Completion: 2022-04-27
• Study Completion: 2022-04-27
• Results First Submitted: 2025-03-20
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Results First Posted: 2025-05-09
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance: Device Malfunctions	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs)
Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time.
Performance: Level of Agreement Between GAT and the ARGOS-IO System	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-IO system (IOP in mmHg) following the Bland-Altman method.

Secondary Outcome Measures

Name	Time	Method
Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening).
Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening).

Trial Locations

Locations (4)

Klinik für Augenheilkunde, Uniklinik RWTH Aachen; 🇩🇪 Aachen, Germany

Universitäts-Augenklinik Bochum; 🇩🇪 Bochum, Germany

Universitätsaugenklinik Magdeburg; 🇩🇪 Magdeburg, Germany

Universitäts-Augenklinik Tübingen; 🇩🇪 Tübingen, Germany