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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
22
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.
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
Performance: Level of Agreement Between GAT and the ARGOS-SC System
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.
Time frame: Day 360 to Day 1080 (V09 to V13)
Safety: Number of Patients Experiencing a Device-related SAE (SADE)
Number of patients experiencing a device-related SAE (SADE)
Time frame: Day 360 to Day 1080 (V09 to V13)
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Time frame: Day 360 to Day 1080 (V09 to V13)
Performance: Percentage of Measurements Within +/- 5 mmHg
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.
Time frame: Day 360 to Day 1080 (V09 to V13)
Performance: Device Malfunctions
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.
Time frame: Day 360 to Day 1080 (V09 to V13)
Usability: User Acceptance at the Investigational Site
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.
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Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi
Lausanne, Switzerland
Time frame: Day 1080 (V13)
Usability: User Acceptance at Home
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.
Time frame: Day 1080 (V13)