Clinical trial NCT04773106: Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Open Angle Glaucoma
Keywords: Non-penetrating glaucoma surgery
Open angle glaucoma
Intraocular pressure measurements
Suprachoroidal pressure sensor
ARGOS-SC
Lead sponsor: Implandata Ophthalmic Products GmbH
Sponsor class: INDUSTRY
Collaborators: name: CRO Dr. med Kottmann GmbH & Co. KG
First posted: 2021-02-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Performance: Level of Agreement Between GAT and the ARGOS-SC System
timeFrame: Day 360 to Day 1080 (V09 to V13)
Secondary outcomes:
measure: Safety: Number of Patients Experiencing a Device-related SAE (SADE)
timeFrame: Day 360 to Day 1080 (V09 to V13)
measure: Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
timeFrame: Day 360 to Day 1080 (V09 to V13)
measure: Performance: Percentage of Measurements Within +/- 5 mmHg
timeFrame: Day 360 to Day 1080 (V09 to V13)
measure: Performance: Device Malfunctions
timeFrame: Day 360 to Day 1080 (V09 to V13)
measure: Usability: User Acceptance at the Investigational Site
timeFrame: Day 1080 (V13)
measure: Usability: User Acceptance at Home
timeFrame: Day 1080 (V13)
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Universitäts-Augenklinik Bochum
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
city: München
country: Germany
facility: Augenklinik der LMU München
city: Sulzbach
country: Germany
facility: Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach
city: Lausanne
country: Switzerland
facility: Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi
Study officials:
affiliation: Knappschaftsklinikum Saar GmbH
name: Peter Szurman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.