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

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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma; Open Angle Glaucoma
• Intervention / Treatment: Device: ARGOS-SC suprachoroidal pressure sensor

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44892
    • Universitäts-Augenklinik Bochum
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
  • München, Germany, 80336
    • Augenklinik der LMU München
  • Sulzbach, Germany, 66280
    • Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
• Switzerland
  • Lausanne, Switzerland, 1006
    • Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Implandata Ophthalmic Products GmbH
• Collaborators: CRO Dr. med. Kottmann GmbH & Co. KG
• Investigators: Principal Investigator: Peter Szurman, Prof., Knappschaftsklinikum Saar GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Anticipated): February 20, 2023
• Study Completion (Anticipated): February 20, 2023

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Non-penetrating glaucoma surgery; Open angle glaucoma; Intraocular pressure measurements; Suprachoroidal pressure sensor; ARGOS-SC
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: ARGOS-SC01_Follow-up

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No