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Completed

NCT Number: NCT04773106

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

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

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension Open Angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäts-Augenklinik Bochum, Bochum, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

ARGOS-SC suprachoroidal pressure sensor

Device

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

Primary outcomes

  1. Performance: Level of Agreement Between GAT and the ARGOS-SC System

    Time frame: 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 outcomes

  1. Safety: Number of Patients Experiencing a Device-related SAE (SADE)

    Time frame: Day 360 to Day 1080 (V09 to V13)

    Number of patients experiencing a device-related SAE (SADE)

  2. Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)

    Time frame: 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.

  3. Performance: Percentage of Measurements Within +/- 5 mmHg

    Time frame: 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.

  4. Performance: Device Malfunctions

    Time frame: 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.

  5. Usability: User Acceptance at the Investigational Site

    Time frame: 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.

  6. Usability: User Acceptance at Home

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Implandata Ophthalmic Products GmbH

Industry

Collaborators

  • CRO Dr. med Kottmann GmbH & Co. KG

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2021
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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