Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)

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

This clinical investigation prospective, open-label, multicenter, single-arm clinical investigation will be conducted in two stages using a Simon two-stage design. Subjects will be enrolled as follows:

First stage: 11 patients Second stage: 11 patients An interim analysis will be performed when the 11 patients of the first stage have completed their 3 month follow-up visits. The trial will be stopped if 2 or more patients have experienced a serious adverse device events (SADE) at this time. Otherwise enrollment will be resumed and the trial continued until an additional 11 patients have been enrolled in stage 2 and received ARGOS-IO implants. A conclusion for safety will be made if in total no more than 2 of the total of 22 patients experience an SADE.

Inclusion Criteria:

1. Mentally competent and willing to provide written informed consent
2. 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.
3. Diagnosis of primary open-angle glaucoma (POAG) including high pressure glaucoma (HPG), normal pressure glaucoma (NPG) and ocular hypertension (OH)
4. Sufficiently controlled intraocular pressure (IOP)
5. Phakic eyes
6. Only one eye per patient may be implanted with the ARGOS-IO implant
7. 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.
8. Pre-operative anterior chamber depth (ACD) ≥2.5 mm
9. Axis length >22 mm
10. Endothelial cell density of the cornea ≥2000 cells/mm²
11. Subjects able and willing to attend all scheduled visits and comply with all study procedures

Exclusion Criteria:

1. Any other type of glaucoma other than primary open-angle glaucoma as defined by inclusion criterion 3
2. Severe POAG patients with a macular degeneration and visual field loss of -20 decibels (dB) or worse
3. Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
4. Retinal detachment
5. Corneal diseases
6. Diabetes mellitus
7. Connective tissue diseases
8. 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
9. Intraocular surgical procedure(s) within 6 months prior to ARGOS-IO implantation or any surgical procedure such as refractive eye surgery that can affect the assessment of IOP by Goldmann applanation tonometry
10. History of eye tumor
11. 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)
12. Anterior chamber configuration that puts the subject at high risk to develop an angle closure glaucoma
13. History of extensive keloid formation
14. Severe dry eye syndrome
15. Subjects who will need to undergo ancillary procedures in the study eye at the time of implantation or during the post-operative study period
16. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, plaster or silicone (component of the device)
17. Existence of other active medical eye implant and/or other active medical implants in the head/neck region
18. 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
19. Severe generalized disease resulting in a life expectancy shorter than a year
20. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
21. Currently pregnant or breastfeeding
22. 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
23. Patients who are not suitable for the study based on the surgeon's evaluation
24. Patients unable or unwilling to understand or comply with required study procedures
25. Patients with psychiatric disorders influencing their judgement or autonomy
26. 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.
27. Enrollment of the fellow eye in this clinical study