Telemetric Measurement of Intraocular Pressure via an Implantable Pressure Sensor—12-Month Results from the ARGOS-02 Trial

Abstract

The aim of this study was to investigate the safety and performance of the second generation of an implantable intraocular pressure (IOP) sensor in patients with primary open angle glaucoma (POAG).DESIGN: prospective, noncomparative, open-label, multicenter clinical investigation.METHODS: In this study, patients with POAG, regularly scheduled for cataract surgery, were implanted with a ring-shaped, sulcus-placed, foldable IOP sensor in a single procedure after intraocular lens implantation. Surgical complications as well as adverse events (AEs) during 12 months of follow-up were recorded. At each follow-up visit, a complete ophthalmic examination, including visual acuity, IOP, slit lamp examination, and dilated funduscopy as well as comparative measurements between Goldmann applanation tonometry and the EYEMATE-IO implant were performed.RESULTS: The EYEMATE-IO implant was successfully implanted in 22 patients with few surgical complications and no unexpected device-related AEs. All ocular AEs resolved quickly under appropriate treatment. Comparative measurements showed good agreement between EYEMATE-IO and Goldmann applanation tonometry (GAT) with an intraclass correlation coefficient (ICC(3,k)) of 0.783 (95% confidence interval [CI]: 0.743, 0.817). EYEMATE-IO measurements were higher than GAT, with a mean difference of 3.2 mm Hg (95% CI: 2.8, 3.5 mm Hg).CONCLUSIONS: The EYEMATE-IO sensor was safely implanted in 22 patients and performed reliably until the end of follow-up. This device allows for continual and long-term measurements of IOP.

Influence of electromagnetic radiation emitted by daily-use electronic devices on the Eyemate® system in-vitro: a feasibility study

“…The eyemate® is a system capable of continuously monitoring IOP intraocularly, designed to be implanted in the patient's eye during cataract surgery in order to transmit IOP measurements telemetrically [10,11]. While the sensor is only active when electromagnetically coupled with an external reader device, patients are constantly surrounded by ambient electromagnetic radiation from other electronic devices.…”

“…Implantation of the sensor is usually performed during cataract surgery, where the sensor is placed in the ciliary sulcus after capsular implantation of the intraocular lens. Once implanted, the sensor is meant to remain in the patient's eye indefinitely [11].…”

Influence of electromagnetic radiation emitted by daily-use electronic devices on the Eyemate® system

“…The eyemate®-IO sensor is designed to be implanted in the patient's eye during cataract surgery in order to transmit IOP measurements telemetrically. [10][11] Because this sensor is constantly sending and receiving electromagnetic signals, patients might fear that their daily use electronic devices may be a source of interference in the IOP measurements. To date, the number of studies investigating this promising new technology and its potential limitations, such as electromagnetic interference, is still lacking.…”

Lageabhängigkeit des Augeninnendruckes bei Glaukompatienten

“…Zusammenfassend ist die Bedeutung dieser IOD-Schwankungen bisher nicht ausreichend verstanden. Neue Ansätze für die Messung des Augeninnendrucks und die Morphometrie des Sehnerven liefern neue und weitergehende Informationen [5][6][7][8][9][10]. Diese Methoden leisten einen Beitrag zur Vertiefung des Verständnisses von Pathoge-nese und Therapie dieser lageabhängigen Augeninnendruckschwankungen.…”