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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

Primary Purpose

Glaucoma, Open Angle Glaucoma

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ARGOS-SC suprachoroidal pressure sensor
Sponsored by
Implandata Ophthalmic Products GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.

Exclusion Criteria:

  • N/A

Sites / Locations

  • Universitäts-Augenklinik Bochum
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
  • Augenklinik der LMU München
  • Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
  • Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm longterm Follow up ARGOS-SC Sensor Pressure system

Arm Description

The ARGOS-SC sensor was already implanted in a previous study as ARGOS-SC01.

Outcomes

Primary Outcome Measures

Performance
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

Safety: Number of patients experiencing a device-related SAE (SADE)
Number of patients experiencing a device-related SAE (SADE)
Safety: Incidence of observed adverse events
Incidence of observed adverse events
Safety: Nature of observed adverse events
Nature of observed adverse events
Safety: Severity of observed adverse events
Severity of observed adverse events
Safety: Seriousness of observed adverse events
Seriousness of observed adverse events
Safety: Incidence of adverse device events
Incidence of adverse device events
Safety: Nature of adverse device events
Nature of adverse device events
Safety: Severity of adverse device events
Severity of adverse device events
Safety: Seriousness of adverse device events
Seriousness of adverse device events
Performance
Repeatability of the ARGOS-SC measurement (IOP Measurement compared to GAT in mmHg)
Performance
Incidence of observed device malfunctions
Performance
Nature of observed device malfunctions
Performance
Seriousness of observed device malfunctions
Utility
User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of physician acceptance questionnaires (by investigators)
Utility
User acceptance of the ARGOS-SC system at home by means of evaluation of patient acceptance questionnaires (patients)
Utility
Daily IOP self-measurement profiles (patients)

Full Information

First Posted
February 21, 2021
Last Updated
March 31, 2022
Sponsor
Implandata Ophthalmic Products GmbH
Collaborators
CRO Dr. med. Kottmann GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT04773106
Brief Title
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
February 20, 2023 (Anticipated)
Study Completion Date
February 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Implandata Ophthalmic Products GmbH
Collaborators
CRO Dr. med. Kottmann GmbH & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open Angle Glaucoma
Keywords
Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm longterm Follow up ARGOS-SC Sensor Pressure system
Arm Type
Other
Arm Description
The ARGOS-SC sensor was already implanted in a previous study as ARGOS-SC01.
Intervention Type
Device
Intervention Name(s)
ARGOS-SC suprachoroidal pressure sensor
Other Intervention Name(s)
EYEMATE-SC
Intervention Description
The ARGOS-SC pressure sensor was additionally used implanted during routine local intraocular pressure lowering procedures in patients in patients with glaucoma undergoing non-penetrating glaucoma surgery in the earlier ARGOS-SC01 study.
Primary Outcome Measure Information:
Title
Performance
Description
Level of Agreement between measurements made using GAT, Pascal DCT and the ARGOS-SC system from V09 (month 12) through V13 (month 36).
Time Frame
Day 360 to Day 1080
Secondary Outcome Measure Information:
Title
Safety: Number of patients experiencing a device-related SAE (SADE)
Description
Number of patients experiencing a device-related SAE (SADE)
Time Frame
Day 360 to Day 1080
Title
Safety: Incidence of observed adverse events
Description
Incidence of observed adverse events
Time Frame
Day 360 to Day 1080
Title
Safety: Nature of observed adverse events
Description
Nature of observed adverse events
Time Frame
Day 360 to Day 1080
Title
Safety: Severity of observed adverse events
Description
Severity of observed adverse events
Time Frame
Day 360 to Day 1080
Title
Safety: Seriousness of observed adverse events
Description
Seriousness of observed adverse events
Time Frame
Day 360 to Day 1080
Title
Safety: Incidence of adverse device events
Description
Incidence of adverse device events
Time Frame
Day 360 to Day 1080
Title
Safety: Nature of adverse device events
Description
Nature of adverse device events
Time Frame
Day 360 to Day 1080
Title
Safety: Severity of adverse device events
Description
Severity of adverse device events
Time Frame
Day 360 to Day 1080
Title
Safety: Seriousness of adverse device events
Description
Seriousness of adverse device events
Time Frame
Day 360 to Day 1080
Title
Performance
Description
Repeatability of the ARGOS-SC measurement (IOP Measurement compared to GAT in mmHg)
Time Frame
Day 360 to Day 1080
Title
Performance
Description
Incidence of observed device malfunctions
Time Frame
Day 360 to Day 1080
Title
Performance
Description
Nature of observed device malfunctions
Time Frame
Day 360 to Day 1080
Title
Performance
Description
Seriousness of observed device malfunctions
Time Frame
Day 360 to Day 1080
Title
Utility
Description
User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of physician acceptance questionnaires (by investigators)
Time Frame
Day 360, Day 1080
Title
Utility
Description
User acceptance of the ARGOS-SC system at home by means of evaluation of patient acceptance questionnaires (patients)
Time Frame
Day 360, Day 1080
Title
Utility
Description
Daily IOP self-measurement profiles (patients)
Time Frame
Day 360 to Day 1080

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor. Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Szurman, Prof.
Organizational Affiliation
Knappschaftsklinikum Saar GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts-Augenklinik Bochum
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Augenklinik der LMU München
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
City
Sulzbach
ZIP/Postal Code
66280
Country
Germany
Facility Name
Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi
City
Lausanne
ZIP/Postal Code
1006
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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