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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

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