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

Overview

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)

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2021

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Safety measured by Incidence of medical-device related adverse events and serious adverse events
    • Time Frame: 3 years
    • 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.
  • Limits of agreement between IOP measurements made using GAT and the ARGOS-IO system at each study visit.
    • Time Frame: 3 years
    • IOP measured in mmHg
  • Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit.
    • Time Frame: 3 Years
    • IOP measured in mmHg
  • Incidence of observed device malfunctions and nature of device malfunction
    • Time Frame: 3 years
    • 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.

Secondary Measures

  • Patient’s compliance in IOP self-monitoring
    • Time Frame: 3 years
    • Daily self-measurements with the ARGOS-IO sensor should be done at least 4 times daily (morning, noon, afternoon, evening)
  • Impact of IOP self-monitoring on glaucoma progression
    • Time Frame: 3 years
    • 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
  • Incidence in glaucoma medication change
    • Time Frame: 3 years
    • Number of glaucoma medication
  • Number of unscheduled visits due to self-measured increased intraocular pressure
    • Time Frame: 3 years
    • The patients decide to come for a visit by their own due to any reason. This will be documented.

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • N/A

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Implandata Ophthalmic Products GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hagen Thieme, Prof., Principal Investigator, Universitätsaugenklinik Magdeburg
  • Overall Contact(s)
    • Janina Hadeler, +49 17661944731, jhadeler@implandata.com

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