A patient has been successfully implanted with an eye pressure sensor for monitoring glaucoma provided by Implandata during its clinical study.
The ophthalmic medical device company is conducting the study, named ARGOS-SC01, to validate the Eyemate-SC sensor implant for continual monitoring of intraocular pressure.
Implandata is currently expanding its study by including the Ophthalmic Clinic of Ruhr-University Bochum (Germany), the Department of Ophthalmology at University Mainz (Germany), and the Montchoisi Clinique Lausanne (Switzerland). It will be monitored by an independent Data Safety Monitoring Board, chaired by former director of Department of Ophthalmology of Medical University Cologne and glaucoma expert Professor Emeritus Günter Krieglstein. The completion of the study is expected by early 2020.
Professor Peter Szurman, of the Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, who performed the implantation said: “The new Implandata sensor is pleasantly small and easy to surgically implant; therefore, most patients undergoing glaucoma surgery are likely to be eligible candidates for such a pressure sensor. This breakthrough product enables glaucoma patients for the first time to monitor their own eye pressure at any point in time. I expect that it will improve therapeutic compliance and also significantly reduce the risk of unnecessary visual field loss or even blindness due to glaucoma.”
Intraocular pressure monitoring is a considerable challenge for glaucoma patients and their ophthalmologists. Current IOP measurement methods require in-office procedures to be performed by trained medical staff. However, these measurements are obtained just a few times a year, although it is known that the eye pressure is highly dynamic and influenced by many parameters and, thus, changing throughout the day.
Max Ostermeier, CEO of Implandata commented: “The successful inclusion of the first ARGOS-SC01 study patient is a pivotal milestone for Implandata towards broadening the use of our Eyemate system, eventually allowing also stand-alone implantation of our proprietary eye pressure sensing devices.”