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

Sponsor

Implandata Ophthalmic Products GmbH (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04773106

Collaborator

CRO Dr. med. Kottmann GmbH & Co. KG (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

4.2

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-SC system.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Open Angle Glaucoma	Device: ARGOS-SC suprachoroidal pressure sensor	N/A

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

Study Type:

Interventional

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 :

Feb 20, 2020

Anticipated Primary Completion Date :

Feb 20, 2023

Anticipated Study Completion Date :

Feb 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Single-arm longterm Follow up ARGOS-SC Sensor Pressure system The ARGOS-SC sensor was already implanted in a previous study as ARGOS-SC01.	Device: ARGOS-SC suprachoroidal pressure sensor 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. Other Names: EYEMATE-SC

Arm

Intervention/Treatment

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

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

Device: ARGOS-SC suprachoroidal pressure sensor

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.

Other Names:

EYEMATE-SC

Outcome Measures

Primary Outcome Measures

Performance [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

Safety: Number of patients experiencing a device-related SAE (SADE) [Day 360 to Day 1080]
Number of patients experiencing a device-related SAE (SADE)
Safety: Incidence of observed adverse events [Day 360 to Day 1080]
Incidence of observed adverse events
Safety: Nature of observed adverse events [Day 360 to Day 1080]
Nature of observed adverse events
Safety: Severity of observed adverse events [Day 360 to Day 1080]
Severity of observed adverse events
Safety: Seriousness of observed adverse events [Day 360 to Day 1080]
Seriousness of observed adverse events
Safety: Incidence of adverse device events [Day 360 to Day 1080]
Incidence of adverse device events
Safety: Nature of adverse device events [Day 360 to Day 1080]
Nature of adverse device events
Safety: Severity of adverse device events [Day 360 to Day 1080]
Severity of adverse device events
Safety: Seriousness of adverse device events [Day 360 to Day 1080]
Seriousness of adverse device events
Performance [Day 360 to Day 1080]
Repeatability of the ARGOS-SC measurement (IOP Measurement compared to GAT in mmHg)
Performance [Day 360 to Day 1080]
Incidence of observed device malfunctions
Performance [Day 360 to Day 1080]
Nature of observed device malfunctions
Performance [Day 360 to Day 1080]
Seriousness of observed device malfunctions
Utility [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)
Utility [Day 360, Day 1080]
User acceptance of the ARGOS-SC system at home by means of evaluation of patient acceptance questionnaires (patients)
Utility [Day 360 to Day 1080]
Daily IOP self-measurement profiles (patients)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitäts-Augenklinik Bochum	Bochum	Germany	44892
2	Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik	Mainz	Germany	55131
3	Augenklinik der LMU München	München	Germany	80336
4	Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach	Sulzbach	Germany	66280
5	Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi	Lausanne	Switzerland	1006