Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients 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 safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.

Detailed Description
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This prospective, open-label, multi center, single-arm clinical investigation will enroll 22 consecutive patients. Enrollment will be temporarily halted in case a serious adverse device effect (SADE) occurs, and Data and Safety Monitoring Board (DSMB) meeting will be conducted as soon as possible. The DSMB will then recommend whether to further continue the study as planned, or whether enrollment shall be stopped. In order to provide a complete overview of the study to the DSMB, an interim analysis will be performed after half of the study population (11-14 subjects) is enrolled with a minimum follow-up of 1 month. A conclusion for safety will be made if in total no more than 2 of the total of 22 patients experience a SADE. The primary aim of this study is to show safety, which will be evaluated based on the percentage of subjects who experience a SADE (=non-safety), as defined in the primary endpoints. The study will be declared a success if the final non-safety event rate is less than 6% (type II error rate of 0.20). The calculation is based on a design optimizing the minimum expected sample size with parameters alpha=0.05, beta=0.20, p0=0.75, p1=0.94.

Official Title
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A Prospective, Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-IO System in Patients With Primary Open Angle Glaucoma (POAG)

Conditions
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Primary Open Angle Glaucoma (POAG)

Intervention / Treatment
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* Device: ARGOS-IO system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mentally competent and willing to provide written informed consent Male or female aged ≥40 and ≤85 years. Female subjects of childbearing potential must be willing to use adequate contraception and must have a negative pregnancy test. Diagnosis of primary open-angle glaucoma (POAG) including high pressure glaucoma (HPG), normal pressure glaucoma (NPG) and ocular hypertension (OH), as defined by the European Glaucoma Society guideline (Heijl, Treverso, et al., 2008) Sufficiently controlled intraocular pressure (IOP) Study eye needs to be phakic Only one eye per patient may be implanted with the ARGOS-IO implant Cataract surgery indicated. The medical indication for a cataract operation 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 cataract operation. Pre-operative anterior chamber depth (ACD) ≥2.0 mm as measured from the corneal endothelium Axis length >22 mm Endothelial cell density of the cornea ≥2000 cells/mm² Subjects able and willing to attend all scheduled visits and comply with all study procedures Exclusion Criteria: Any other type of glaucoma other than primary open-angle glaucoma as defined by inclusion criterion 3 Severe POAG patients with a macular degeneration and visual field loss of -20 decibels (dB) or worse in both eyes. In case of a diverse developed visual field loss, the sensor can be implanted in the worse eye for protection the better eye. Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema Retinal detachment Corneal diseases, especially diseases affecting the corneal endothelium, e.g. Fuchs' Dystrophia Diabetes mellitus Existence of Marfan-Syndrome, Ehlers-Danlos-Syndrome or Weill-Marchesani-Syndrome History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to ARGOS-IO implantation Intraocular surgical procedure(s) within 6 months prior to ARGOS-IO implantation or any surgical procedure such as refractive eye surgery in the study eye that can affect the assessment of IOP by Goldmann applanation tonometry History of eye tumor Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP by Goldmann applanation tonometry (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy) Anterior chamber configuration that puts the subject at high risk to develop an angle closure glaucoma History of extensive keloid formation Severe dry eye syndrome Subjects who will need to undergo ancillary procedures in the study eye at the time of implantation or during the post-operative study period Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, plaster or silicone (component of the device) Existence of other active medical eye implant and/or other active medical implants in the head/neck region Any contraindication for intraocular lens (IOL) implantation such as choroidal hemorrhage, concomitant severe eye disease, excessive vitreous loss, extremely shallow anterior chamber, microphthalmos, non-age-related cataract, posterior capsular rupture, severe corneal dystrophy, untraceable IOP, zonular separation, color vision deficiencies Severe generalized disease resulting in a life expectancy shorter than a year Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device 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: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: Single-arm intervention ARGOS-IO system<br>The ARGOS-IO Pressure sensor will be additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery. | Device: ARGOS-IO system<br>* Implantation of ARGOS-IO pressure sensor after cataract surgery on day 0 (V01)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of patients experiencing a device related serious adverse event (SAE) defined as any adverse event that both Is considered by the Investigator to have a possible, probable or definite relationship to the device and That meets any of the following criteria of a serious adverse event: Resulted in death, permanent damage or disability or a congenital anomaly Was life threatening Required hospitalization or intervention to prevent permanent impairment or damage | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Incidence of observed adverse events and adverse device events during a period between 3 months and 12 months following implantation. | 12 months | 
| Severity of adverse events | Severity of observed adverse events and adverse device events during a period between 3 months and 12 months following implantation. | 12 months | 
| Performance | Limits of agreement between measurements made using GAT and the ARGOS-IO system from V05 (day 30) through V11 (day 360) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Open Angle Glaucoma, POAG, Glaucoma, Cataract, Surgery, Ocular Pressure