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

Not Applicable

Completed

• Conditions: Glaucoma; Open Angle Glaucoma
• Interventions: Device: ARGOS-SC suprachoroidal pressure sensor

• Registration Number: NCT04773106
• Lead Sponsor: Implandata Ophthalmic Products GmbH

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.

Study Timeline

• Study Start: 2020-02-20
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-26
• Primary Completion: 2023-03-02
• Study Completion: 2023-03-02
• Results First Submitted: 2025-03-25
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Results First Posted: 2025-05-18
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm longterm Follow up ARGOS-SC Sensor Pressure system	ARGOS-SC suprachoroidal pressure sensor	The ARGOS-SC sensor was already implanted in a previous study as ARGOS-SC01.

Primary Outcome Measures

Name	Time	Method
Performance: Level of Agreement Between GAT and the ARGOS-SC System	Day 360 to Day 1080 (V09 to V13)	Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.

Secondary Outcome Measures

Name	Time	Method
Safety: Number of Patients Experiencing a Device-related SAE (SADE)	Day 360 to Day 1080 (V09 to V13)	Number of patients experiencing a device-related SAE (SADE)
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)	Day 360 to Day 1080 (V09 to V13)	Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Performance: Percentage of Measurements Within +/- 5 mmHg	Day 360 to Day 1080 (V09 to V13)	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.
Performance: Device Malfunctions	Day 360 to Day 1080 (V09 to V13)	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.
Usability: User Acceptance at the Investigational Site	Day 1080 (V13)	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.
Usability: User Acceptance at Home	Day 1080 (V13)	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.

Trial Locations

Locations (5)

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik; 🇩🇪 Mainz, Germany

Universitäts-Augenklinik Bochum; 🇩🇪 Bochum, Germany

Augenklinik der LMU München; 🇩🇪 München, Germany

Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach; 🇩🇪 Sulzbach, Germany

Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi; 🇨🇭 Lausanne, Switzerland