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NCT04773106 Clinical Trial

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

Glaucoma Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04773106
Other study ID # ARGOS-SC01_Follow-up
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 20, 2020
Est. completion date February 20, 2023

Study information
Verified date March 2022
Source Implandata Ophthalmic Products GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 21
Est. completion date February 20, 2023
Est. primary completion date February 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor. Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Germany Universitäts-Augenklinik Bochum Bochum
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik Mainz
Germany Augenklinik der LMU München München
Germany Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach Sulzbach
Switzerland Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi Lausanne

Sponsors (2)
Lead Sponsor Collaborator
Implandata Ophthalmic Products GmbH CRO Dr. med. Kottmann GmbH & Co. KG

Countries where clinical trial is conducted

Germany,  Switzerland, 

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