CompletedNot Applicable

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

Germany24 participantsStarted 2014-07-09

Plain-language summary

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.

Age range40 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation

Timeframe: Day 0 to Day 360 (V01 [Implantation] to V11)

Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System

Timeframe: Day 30 to Day 360 (V05 to V11)

NCT IDNCT02434692

SponsorImplandata Ophthalmic Products GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-11

Results submitted2022-08-05

Who can participate