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OMNI® Chirurgiesystem : Wichtige Sicherheitsinformationen

INDIKATIONEN ZUR ANWENDUNG

Das OMNI®-Chirurgiesystem ist für die Katheterisierung und transluminale Viskodilatation des Schlemm’schen Kanals und zur Eröffnung des Trabekelmaschenwerks zur Reduzierung des Augeninnendrucks bei erwachsenen Patienten mit Offenwinkelglaukom indiziert.

In einer klinischen Studie zum OMNI-Chirurgiesystem1,2 waren die im Anschluss an den Eingriff am häufigsten berichteten (>5%) Komplikationen Sekundärkatarakt (15%), leichte Augenentzündung (11%), Schwellung der zentralen Netzhaut (5%), Hornhautschwellung (5%) und erhöhter Augeninnendruck (5%). Bitte sprechen Sie mit Ihrem Arzt über eventuelle Risiken und fragen Sie, ob eine Behandlung mit dem OMNI-System für Sie möglich ist.

1. Hirsch et al. J Cataract Refract Surg. 2021 ; 47(7) : 907-915
2. Vold et al. Ophthalmol Glaucoma. 2021 ; 4 : 173-181

Indications and Safety Information

Indications for use

The OMNI® Surgical System is indicated for the catheterization and transluminal viscodilation of Schlemm’s canal and the cutting of trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.

Contraindications

1. Do not use the OMNI in any situations where the angle is compromised or has been damaged (e.g., from trauma or surgery), since it may not be possible to visualize the angle or to properly pass the microcatheter.
2. Do not use the OMNI in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris.

Warnings

1. Do not use in cases where there is insufficient visibility to properly see the angle. The following conditions may prohibit sufficient visualization of the angle required for safe and successful cannula placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit gonioscopic view of the angle and intended cannula entry location.
2. Perform gonioscopy prior to taking a patient to surgery to exclude congenital anomalies of the angle, anterior segment dysgeneses, peripheral anterior synechiae (PAS), rubeosis, and any other angle abnormalities that could lead to improper placement of the cannula and microcatheter and pose a hazard.
3. Maintain direct microscopic or gonioscopic visualization of the cannula tip and microcatheter tip at all times during the procedure to facilitate advancement and to avoid inadvertently damaging intraocular structures, kinking the microcatheter or unintended tearing of trabecular meshwork.

Potential adverse events

Adverse events that may be reasonably associated with the use of the OMNI® System in the eye include but are not limited to the following: anterior chamber shallowing, severe, prolonged, or persistent intraocular inflammation including toxic anterior segment syndrome (TASS), endophthalmitis or other ocular infection, aqueous misdirection, Descemet’s membrane tear or detachment, intracorneal hematoma, choroidal effusion, suprachoroidal hemorrhage, corneal decompensation, corneal injury, corneal edema or opacification, unintended trabeculotomy, cyclodialysis cleft, hyphema, hypopyon, hypotony, hypotony maculopathy, IOL dislocation, cataract formation, iris injury, tear, or iridodialysis, loss of vitreous, perforation of sclera, posterior capsular bag rupture, proliferative vitreoretinopathy, pupillary block, pupillary membrane formation, retinal detachment, retinal dialysis, retinal flap tears, secondary surgical intervention, including but not limited to glaucoma surgery, and vitreous hemorrhage.

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