Device profile of the EYEMATE-IO™ system for intraocular pressure monitoring: overview of its safety and efficacy.

Assessment of intraocular pressure (IOP) is a core diagnostic tool in management of glaucoma. All established ways to measure IOP use indirect approaches through ocular tissues, mainly the cornea or the sclera. Telemetric IOP measurement with an implantable device could eliminate bias caused by indirect techniques and could allow continuous monitoring. A favorable safety profile, high efficacy and good tolerability are key requirements. The Eyemate-IO™ system (Implandata Ophthalmic Products GmbH, Hannover, Germany) is a novel CE-marked implantable medical device for direct measurement of IOP. It consists of an intraocular sensor ring and an external reading device. This review presents the mechanism of telemetric IOP measurement and summarizes the available clinical data. Twelve months follow-up data of two clinical trials provide support for the efficacy and safety of this device. The implantable Eyemate-IO™ in keratoprosthesis was well tolerated; recorded adverse events were known complications of standalone surgery. The system had a good agreement with other IOP measuring modalities, including intraoperative manometry. In glaucoma patients, the Eyemate-IO™ could be implanted safely and showed a favorable efficacy and safety profile in the first twelve months postoperatively. The potential to achieve IOP monitoring with the Eyemate-IO™ seems promising. [ABSTRACT FROM AUTHOR]