Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.

Detailed Description
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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.

Official Title
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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)

Conditions
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Glaucoma, Open Angle Glaucoma

Intervention / Treatment
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* Device: ARGOS-SC suprachoroidal pressure sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor. Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm longterm Follow up ARGOS-SC Sensor Pressure system<br>The ARGOS-SC sensor was already implanted in a previous study as ARGOS-SC01. | Device: ARGOS-SC suprachoroidal pressure sensor<br>* 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.<br>* Other names: EYEMATE-SC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of patients experiencing a device-related SAE (SADE) | Number of patients experiencing a device-related SAE (SADE) | Day 360 to Day 1080 | 
| Safety: Incidence of observed adverse events | Incidence of observed adverse events | Day 360 to Day 1080 | 
| Safety: Nature of observed adverse events | Nature of observed adverse events | Day 360 to Day 1080 | 
| Safety: Severity of observed adverse events | Severity of observed adverse events | Day 360 to Day 1080 | 
| Safety: Seriousness of observed adverse events | Seriousness of observed adverse events | Day 360 to Day 1080 | 
| Safety: Incidence of adverse device events | Incidence of adverse device events | Day 360 to Day 1080 | 
| Safety: Nature of adverse device events | Nature of adverse device events | Day 360 to Day 1080 | 
| Safety: Severity of adverse device events | Severity of adverse device events | Day 360 to Day 1080 | 
| Safety: Seriousness of adverse device events | Seriousness of adverse device events | Day 360 to Day 1080 | 
| Performance | Repeatability of the ARGOS-SC measurement (IOP Measurement compared to GAT in mmHg) | Day 360 to Day 1080 | 
| Performance | Incidence of observed device malfunctions | Day 360 to Day 1080 | 
| Performance | Nature of observed device malfunctions | Day 360 to Day 1080 | 
| Performance | Seriousness of observed device malfunctions | Day 360 to Day 1080 | 
| 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 | 
| Utility | User acceptance of the ARGOS-SC system at home by means of evaluation of patient acceptance questionnaires (patients) | Day 360, Day 1080 | 
| Utility | Daily IOP self-measurement profiles (patients) | Day 360 to Day 1080 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC