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

A Prospective, Open-label, Multicenter Clinical Follow-up Investigation of the ARGOS-01 and ARGOS-02 Patients to Assess the Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

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)

Study Overview

• Status: Completed
• Conditions: Primary Open-angle Glaucoma
• Intervention / Treatment: Device: ARGOS-IO Sensor Pressure System

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Klinik für Augenheilkunde, Uniklinik RWTH Aachen
  • Bochum, Germany, 44892
    • Universitäts-Augenklinik Bochum
  • Magdeburg, Germany, 39120
    • Universitätsaugenklinik Magdeburg
  • Tübingen, Germany, 72076
    • Universitäts-Augenklinik Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single-arm longterm follow-up ARGOS-IO Sensor Pressure System; The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02.	Device: ARGOS-IO Sensor Pressure System; The ARGOS-IO Pressure sensor have been additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in previous studies ARGOS-01 and ARGOS-02; Other Names: EYEMATE-IO

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)	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).	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)	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).	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)

Collaborators and Investigators

• Sponsor: Implandata Ophthalmic Products GmbH
• Investigators: Principal Investigator: Hagen Thieme, Prof., Universitätsaugenklinik Magdeburg

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: POAG; Cataract; Intraocular Pressure; IOP; Primary Open Angle Glaucoma; Intraocular Pressure Sensor System; Self-monitoring of intraocular pressure
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: ARGOS-03; CIV-18-13-023284 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No