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): 13
• 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: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 measured by Incidence of medical-device related adverse events and serious adverse events	The primary objective of this clinical trial is to evaluate the long-term safety and tolerability of the ARGOS-IO pressure sensor under consideration of incidence, nature, severity and seriousness of observed medical device related adverse and serious adverse events.An AE is considered to be device-related if there is at least a possible relationship to the medical device according to the rating of the investigator.	3 years
Limits of agreement between IOP measurements made using GAT and the ARGOS-IO system at each study visit.	IOP measured in mmHg	3 years
Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit.	IOP measured in mmHg	3 Years
Incidence of observed device malfunctions and nature of device malfunction	A device malfunction is e.g. difference of more than 5 mmHg between ARGOS-IO and GAT, readout error of the Mesograph because of measurements outside -2 and +70mmHG.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's compliance in IOP self-monitoring	Daily self-measurements with the ARGOS-IO sensor should be done at least 4 times daily (morning, noon, afternoon, evening)	3 years
Impact of IOP self-monitoring on glaucoma progression	Visual field (db), cup/disc ratio, OCT of the optic nerve (µm) and the IOP (mmHg) has to be compared together to evaluate glaucoma progression	3 years
Incidence in glaucoma medication change	Number of glaucoma medication	3 years
Number of unscheduled visits due to self-measured increased intraocular pressure	The patients decide to come for a visit by their own due to any reason. This will be documented.	3 years

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): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

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)

Drug and device information, study documents

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