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

ABSTRACT

Introduction

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.

Areas covered

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.

Expert opinion

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.

KEYWORDS:

• Telemetric intraocular pressure monitoring
• Eyemate-IO
• glaucoma
• Boston type I keratoprosthesis
• IOP
• intraocular pressure

Article highlights

• An implantable intraocular pressure sensor device allows direct, telemetric measurement of the intraocular pressure in glaucoma patients.

• Direct intraocular pressure assessment could reduce bias immanent in indirect measuring techniques and provide 24-hour monitoring data.

• Two recently published clinical trials analyzed the use of an intraocular pressure sensor, the Eyemate-IO™, in glaucoma patients undergoing cataract surgery and patients undergoing keratoprosthesis surgery.

• The Eyemate-IO™ showed a promising safety profile in the first 12 months of follow-up. Adverse events that occurred were expected and transitory.

• The implant had a good performance regarding consistency to other modalities for measurement of the intraocular pressure.

• The concept of sensor-based intraocular pressure measurement seems promising.

Declaration of interest

The authors’ institution, the Department of Ophthalmology, University Hospital of Cologne, Germany, was a study site of the ARGOS-KP trial and received reimbursement from Implandata GmbH, Hannover, Germany for any study-related proceedings. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.