Performance and Safety of the ARGOS-SC01 Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery

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 able to understand the informed consent and willing to participate as evidenced by providing informed consent. Male or female aged ≥ 18 years on the day of screening Female subjects of childbearing potential (not surgically sterilized or more than one year post-menopausal) must be willing to use adequate contraception throughout the trial and must have a negative pregnancy test (urine beta-hCG) within 24 hours prior to ARGOS-SC pressure sensor implantation. Diagnosis of open angle glaucoma requiring a non-penetrating glaucoma surgery (NPGS). The medical indication for a non-penetrating glaucoma surgery must be given irrespective of the study participation. Potential study patients will be solicited for participation in the clinical trial only after the patient has given consent to the non-penetrating glaucoma operation. Subjects able and willing to attend all scheduled visits and comply with all study procedures Exclusion Criteria: Contraindications for a non-penetrating glaucoma surgery Neovascular glaucoma, primary and secondary angle closure glaucoma Condition after previous glaucoma incisional surgery IOP > 40 mmHg Myopia (> -6 dpt) or hypermetropia (> +4 dpt) Axis length < 22 mm or > 26 mm Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema Acute retinal detachment Uncontrolled Diabetes Mellitus (DM) with manifestation of moderate to severe non-proliferative diabetic Retinopathy (DR) or proliferative DR. History or evidence of severe active inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to ARGOS-SC implantation Ocular surgery procedure(s) (excluding selective laser trabeculoplasty and peripheral iridotomy) within 6 months (cataract surgery within 3 months) prior to ARGOS-SC implantation in the study eye that can affect the assessment of IOP by Goldmann Applanation tonometry Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP by Goldmann Applanation tonometry/Pascal Dynamic Contour Tonometry (e.g. choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy) Existence of other active medical eye implant and/or other active medical implants in the head/neck region Difficulties or complications during NPGS procedure or implantation of ARGOS-SC sensor, as assessed by surgeon (e.g. perforation of trabeculo-descement's membrane; excessive aqueous filtration through TDM leading to shallow anterior chamber; excessive bleeding; choroidal detachment) Severe generalized disease resulting in a life expectancy shorter than a year Currently pregnant or breastfeeding Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device Patients who are not suitable for the study based on the surgeon's evaluation Patients unable or unwilling to understand or comply with required study procedures Patients with psychiatric disorders influencing their judgement or autonomy Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization. Enrollment of the fellow eye in this clinical study

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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Accepts Healthy Volunteers

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
Interventional Model Description: Prospective, open-label, single arm, multicenter
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ARGOS-SC suprachoroidal pressure sensor|The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.|

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 (IOP in mmHg) | Day 1 to Day 360 | 

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) | During implantation and 12 months follow-up | 
| Safety: Incidence, nature, severity and seriousness of observed adverse events and adverse device events | Incidence, nature, severity and seriousness of observed adverse events and adverse device events | During implantation and 12 months follow-up | 
| Performance | Repeatability of the ARGOS-SC measurement | Day 2 to Day 360 | 
| Performance | Incidence, nature and seriousness of observed device malfunctions | During implantation and 12 months follow-up | 
| Utility | 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) | Day 1 | 
| Utility | 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) | Day 2 to Day 360 | 
| Utility | 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) | Day 2 to Day 360 | 

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