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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)

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ClinicalTrials.gov Identifier: NCT03651336
Recruitment Status : Active, not recruiting
First Posted : August 29, 2018
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Implandata Ophthalmic Products GmbH

Study Description
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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
Primary Open-angle Glaucoma Device: ARGOS-IO Sensor Pressure System Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : August 15, 2018
Estimated Primary Completion Date : May 13, 2022
Estimated Study Completion Date : May 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
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 Name: EYEMATE-IO


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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 Outcome Measures :
  1. 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)

  2. 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

  3. Incidence in glaucoma medication change [ Time Frame: 3 years ]
    Number of glaucoma medication

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651336


Locations
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Germany
Klinik für Augenheilkunde, Uniklinik RWTH Aachen
Aachen, Germany, 52074
Universitäts-Augenklinik Bochum
Bochum, Germany, 44892
Universitätsaugenklinik Magdeburg
Magdeburg, Germany, 39120
Universitäts-Augenklinik Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
Implandata Ophthalmic Products GmbH
Investigators
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Principal Investigator: Hagen Thieme, Prof. Universitätsaugenklinik Magdeburg
More Information
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Responsible Party: Implandata Ophthalmic Products GmbH
ClinicalTrials.gov Identifier: NCT03651336    
Other Study ID Numbers: ARGOS-03
CIV-18-13-023284 ( Other Identifier: EUDAMED )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020

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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:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases