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

Sponsor
Implandata Ophthalmic Products GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03651336
Collaborator
(none)
13
Enrollment
4
Locations
1
Arm
44.4
Actual Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Device: ARGOS-IO Sensor Pressure System
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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)
Actual Study Start Date :
Aug 15, 2018
Actual Primary Completion Date :
Apr 27, 2022
Actual Study Completion Date :
Apr 27, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety measured by Incidence of medical-device related adverse events and serious adverse events [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.

    2. Limits of agreement between IOP measurements made using GAT and the ARGOS-IO system at each study visit. [3 years]

      IOP measured in mmHg

    3. Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit. [3 Years]

      IOP measured in mmHg

    4. Incidence of observed device malfunctions and nature of device malfunction [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 Outcome Measures

    1. Patient's compliance in IOP self-monitoring [3 years]

      Daily self-measurements with the ARGOS-IO sensor should be done at least 4 times daily (morning, noon, afternoon, evening)

    2. Impact of IOP self-monitoring on glaucoma progression [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

    3. Incidence in glaucoma medication change [3 years]

      Number of glaucoma medication

    4. Number of unscheduled visits due to self-measured increased intraocular pressure [3 years]

      The patients decide to come for a visit by their own due to any reason. This will be documented.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.
    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinik für Augenheilkunde, Uniklinik RWTH Aachen Aachen Germany 52074
    2 Universitäts-Augenklinik Bochum Bochum Germany 44892
    3 Universitätsaugenklinik Magdeburg Magdeburg Germany 39120
    4 Universitäts-Augenklinik Tübingen Tübingen Germany 72076

    Sponsors and Collaborators

    • Implandata Ophthalmic Products GmbH

    Investigators

    • Principal Investigator: Hagen Thieme, Prof., Universitätsaugenklinik Magdeburg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Implandata Ophthalmic Products GmbH
    ClinicalTrials.gov Identifier:
    NCT03651336
    Other Study ID Numbers:
    • ARGOS-03
    • CIV-18-13-023284
    First Posted:
    Aug 29, 2018
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Implandata Ophthalmic Products GmbH
    POAG
    Primary Open Angle Glaucoma
    Cataract
    Intraocular Pressure
    Intraocular Pressure Sensor System
    IOP
    Self-monitoring of intraocular pressure
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of Jul 12, 2022