The purpose of this study is to evaluate both the safety and feasibility of the surgical implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety and usability of the ARGOS-SC implant and system in the year following the implantation.
This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. Subjects will be followed up at regular intervals for one year following implantation to collect safety and performance information. Enrollment will be halted at every serious adverse device event (SADE). The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery and is used in conjunction with the hand-held MESOGRAPH reading device to telemetrically measure the intraocular pressure (IOP) of the implanted eye. The sample size calculation was based on the study's dual purpose of establishing safety and comparability of IOP measurements with the ARGOS-SC system to those made with GAT and DCT. IOP measurements will be made with all devices at various time points, resulting in a within individual control for IOP variables. Based on these calculations (performance, safety) and considering possible drop-outs, the exploratory investigation will enroll 24 patients. The minimum number of measurements required to hold the performance claim is approx. 120. With multiple (\>8) measurements with either method (ARGOS, GAT) per patient, a sufficient number of paired measurements (in total \>\>120 measurement pairs) will be available to show equivalence of the methods (primary objective).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.
Universitäts-Augenklinik
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 1 to Day 360 (V02 to V09)
Safety: Number of Patients Experiencing a Device-related SAE (SADE)
Number of patients experiencing a device-related SAE (SADE).
Time frame: Day 0 to Day 360 (V01 [Implantation] to V09)
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 0 to Day 360 (V01 [Implantation] to V09)
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 70% agreement of the total number of comparisons between +/-5 mmHg. The first column presents the overall data and the second column presents data from 3 months postoperatively onwards.
Time frame: Day 1 to Day 360 (V02 to V09)
Performance: Device Malfunctions
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs).
Time frame: Day 0 to Day 360 (V01 [Implantation] to V09)
Usability: Implantation Procedure
User acceptance of the ARGOS-SC implantation procedure by means of evaluation of implantation procedure questionnaires (surgeons) on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). Overall Number of Participant Analyzed represents the 7 surgeons who provided feedback via a structured 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 1 (V01 [Implantation])
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 12 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance.
Time frame: Day 1 to Day 360 (V02 to V09)
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 1 to Day 360 (V02 to V09)