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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)
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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, Germany
Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi
Lausanne, Switzerland
Start Date
February 20, 2020
Primary Completion Date
March 2, 2023
Completion Date
March 2, 2023
Last Updated
May 18, 2025
22
ACTUAL participants
ARGOS-SC suprachoroidal pressure sensor
DEVICE
Lead Sponsor
Implandata Ophthalmic Products GmbH
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07396441