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Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04773106
Recruitment Status : Active, not recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Collaborator:
CRO Dr. med. Kottmann GmbH & Co. KG
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-SC system.

Condition or disease Intervention/treatment Phase
Glaucoma Open Angle Glaucoma Device: ARGOS-SC suprachoroidal pressure sensor Not Applicable

Detailed Description:

This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01-FU 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 : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Follow-up of the First in Man, Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery (Follow-up Month 12 - Month 36)
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : February 20, 2023
Estimated Study Completion Date : February 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Intervention Details:
  • Device: ARGOS-SC suprachoroidal pressure sensor
    Single-arm longterm follow-up ARGOS-SC suprachoroidal pressure Sensor System. The ARGOS-SC suprachoroidal pressure Sensor was already implanted in a previous Study-ARGOS-SC01.

Outcome Measures
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Primary Outcome Measures :
  1. Performance [ Time Frame: Day 360 to Day 1080 ]
    Level of Agreement between measurements made using GAT, Pascal DCT and the ARGOS-SC system from V09 (month 12) through V13 (month 36).


Secondary Outcome Measures :
  1. Safety: Number of patients experiencing a device-related SAE (SADE) [ Time Frame: Day 360 to Day 1080 ]
    Number of patients experiencing a device-related SAE (SADE)

  2. Safety: Incidence of observed adverse events [ Time Frame: Day 360 to Day 1080 ]
    Incidence of observed adverse events

  3. Safety: Nature of observed adverse events [ Time Frame: Day 360 to Day 1080 ]
    Nature of observed adverse events

  4. Safety: Severity of observed adverse events [ Time Frame: Day 360 to Day 1080 ]
    Severity of observed adverse events

  5. Safety: Seriousness of observed adverse events [ Time Frame: Day 360 to Day 1080 ]
    Seriousness of observed adverse events

  6. Safety: Incidence of adverse device events [ Time Frame: Day 360 to Day 1080 ]
    Incidence of adverse device events

  7. Safety: Nature of adverse device events [ Time Frame: Day 360 to Day 1080 ]
    Nature of adverse device events

  8. Safety: Severity of adverse device events [ Time Frame: Day 360 to Day 1080 ]
    Severity of adverse device events

  9. Safety: Seriousness of adverse device events [ Time Frame: Day 360 to Day 1080 ]
    Seriousness of adverse device events

  10. Performance [ Time Frame: Day 360 to Day 1080 ]
    Repeatability of the ARGOS-SC measurement (IOP Measurement compared to GAT in mmHg)

  11. Performance [ Time Frame: Day 360 to Day 1080 ]
    Incidence of observed device malfunctions

  12. Performance [ Time Frame: Day 360 to Day 1080 ]
    Nature of observed device malfunctions

  13. Performance [ Time Frame: Day 360 to Day 1080 ]
    Seriousness of observed device malfunctions

  14. Utility [ Time Frame: Day 360, Day 1080 ]
    User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of physician acceptance questionnaires (by investigators)

  15. Utility [ Time Frame: Day 360, Day 1080 ]
    User acceptance of the ARGOS-SC system at home by means of evaluation of patient acceptance questionnaires (patients)

  16. Utility [ Time Frame: Day 360 to Day 1080 ]
    Daily IOP self-measurement profiles (patients)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal 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): NCT04773106


Locations
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Germany
Universitäts-Augenklinik Bochum
Bochum, Germany, 44892
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, Germany, 55131
Augenklinik der LMU München
München, Germany, 80336
Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
Sulzbach, Germany, 66280
Switzerland
Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi
Lausanne, Switzerland, 1006
Sponsors and Collaborators
Implandata Ophthalmic Products GmbH
CRO Dr. med. Kottmann GmbH & Co. KG
Investigators
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Principal Investigator: Peter Szurman, Prof. Knappschaftsklinikum Saar GmbH
More Information
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Responsible Party: Implandata Ophthalmic Products GmbH
ClinicalTrials.gov Identifier: NCT04773106    
Other Study ID Numbers: ARGOS-SC01_Follow-up
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

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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:
Non-penetrating glaucoma surgery
Open angle glaucoma
Intraocular pressure measurements
Suprachoroidal pressure sensor
ARGOS-SC
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases