Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

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-IO system in patients with Primary Open Angle Glaucoma (POAG)

Detailed Description
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This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients. From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study. Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this study. The sensor was always implanted in one eye only which will be the study eye.

Official Title
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A Prospective, Open-label, Multicenter Clinical Follow-up Investigation of the ARGOS-01 and ARGOS-02 Patients to Assess the Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

Conditions
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Primary Open-angle Glaucoma

Intervention / Treatment
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* Device: ARGOS-IO Sensor Pressure System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor. Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 40 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-IO Sensor Pressure System<br>The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02. | Device: ARGOS-IO Sensor Pressure System<br>* The ARGOS-IO Pressure sensor have been additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in previous studies ARGOS-01 and ARGOS-02<br>* Other names: EYEMATE-IO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by Incidence of medical-device related adverse events and serious adverse events | The primary objective of this clinical trial is to evaluate the long-term safety and tolerability of the ARGOS-IO pressure sensor under consideration of incidence, nature, severity and seriousness of observed medical device related adverse and serious adverse events.An AE is considered to be device-related if there is at least a possible relationship to the medical device according to the rating of the investigator. | 3 years | 
| Limits of agreement between IOP measurements made using GAT and the ARGOS-IO system at each study visit. | IOP measured in mmHg | 3 years | 
| Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit. | IOP measured in mmHg | 3 Years | 
| Incidence of observed device malfunctions and nature of device malfunction | A device malfunction is e.g. difference of more than 5 mmHg between ARGOS-IO and GAT, readout error of the Mesograph because of measurements outside -2 and +70mmHG. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's compliance in IOP self-monitoring | Daily self-measurements with the ARGOS-IO sensor should be done at least 4 times daily (morning, noon, afternoon, evening) | 3 years | 
| Impact of IOP self-monitoring on glaucoma progression | Visual field (db), cup/disc ratio, OCT of the optic nerve (µm) and the IOP (mmHg) has to be compared together to evaluate glaucoma progression | 3 years | 
| Incidence in glaucoma medication change | Number of glaucoma medication | 3 years | 
| Number of unscheduled visits due to self-measured increased intraocular pressure | The patients decide to come for a visit by their own due to any reason. This will be documented. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-monitoring of intraocular pressure, POAG, Primary Open Angle Glaucoma, Cataract, Intraocular Pressure, Intraocular Pressure Sensor System, IOP