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: Completed
• 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): 22
• 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

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: ARGOS-SC Sensor; The ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study.	Device: ARGOS-SC suprachoroidal pressure sensor; The ARGOS-SC pressure sensor was additionally implanted during routine local intraocular pressure lowering procedures 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 GAT and the ARGOS-SC System	Level of Agreement between intraocular pressure (IOP) measurements made using GAT & the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.	Day 360 to Day 1080 (V09 to V13)

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 (V09 to V13)
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)	Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.	Day 360 to Day 1080 (V09 to V13)
Performance: Percentage of Measurements Within +/- 5 mmHg	Concordance of the ARGOS-SC<>GAT measurement. Method applied: The probability distribution of the difference in the measurements made using GAT & the ARGOS-SC system per visit ("paired measurement") grouped within 1 mmHg was compared to the outcome measure of achieving 65% agreement of the total number of comparisons between +/-5 mmHg.	Day 360 to Day 1080 (V09 to V13)
Performance: Device Malfunctions	The number of observed device malfunctions / deficiencies (DDs) related to the ARGOS-SC system, consisting of the ARGOS-SC implant and an external handheld reader device for the activation, power supply, and readout of the implanted sensor.	Day 360 to Day 1080 (V09 to V13)
Usability: User Acceptance at the Investigational Site	User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of Investigator's questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). Overall Number of Participants Analyzed represents the 8 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance.	Day 1080 (V13)
Usability: User Acceptance at Home	User acceptance of the ARGOS-SC system at home by means of evaluation of patient questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). The score 7 represents a greater user acceptance.	Day 1080 (V13)

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

Publications and helpful links

General Publications

• Micheletti E, Mansouri K, Dick HB, Hoffmann EM, Mackert MJ, Weinreb RN, Szurman P; EYEMATE-SC Study Group. Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology. 2025 Jan 31:S0161-6420(25)00075-2. doi: 10.1016/j.ophtha.2025.01.021. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): March 2, 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): May 18, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

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; CIV-19-11-030784 (Registry Identifier: Eudamed)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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