27 July 2020 | News
Digital Health: Clinical Study Published in “Ophthalmology” Demonstrates Implandata’s EYEMATE System Benefits Glaucoma Patients
People suffering from glaucoma got bad news and good news from a clinical study published in the journal Ophthalmology (1) this month. Bad news: Clinical data prove, the current standard practice (applanation tonometry) for measuring IntraOcular Pressure (IOP) does not provide an accurate representation of an individual’s real IOP over time. Good news: The clinical study concludes, continual monitoring via Implandata’s EYEMATE™ System enables accurate IOP measurement and improved glaucoma care, to protect the patients’ eyesight.
What this means for people with glaucoma
Standard practice currently is to measure glaucoma patients’ IOP in a doctor’s office, typically 4x to 6x/year. For patients, this means a high risk of undetected disease progression, which can result in vision loss. Clinical studies show, the EYEMATE™ System enables safe, reliable, continual IOP monitoring, without necessitating regular office visits. EYEMATE enables patients and their doctors to be informed in real-time of disease progression, which means the therapy is adjusted without delay – before eyesight is permanently lost.
What glaucoma experts say
Prof. Kaweh Mansouri, MD, MPH, lead author of the study and ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland, explains: "Our findings show that occasional IOP measurements, as are currently done in clinical practice, poorly reflect actual IOP behavior in patients. These data underline the importance of continual IOP monitoring for better management of glaucoma care."
Prof. Robert N. Weinreb MD, Chair and Distinguished Professor of Ophthalmology at the University of California, San Diego states: "Our findings have important implications both for clinical glaucoma management as well as clinical trials. Although results from a single session of IOP monitoring have limited benefit for predicting IOP behavior, the current assumption of conserved IOP patterns over weeks and months is used at present in glaucoma management and underlies numerous glaucoma medication trials. The evidence for this premise, however, has always been weak, since few studies previously have addressed this issue."
Leading eye centers support EYEMATE
The CE-marked EYEMATE system is now offered to patients by leading eye centers in Germany, Switzerland and the UK. Further clinics are on the EYEMATE waiting list. The FDA “Breakthrough Device” approval process has been started, in preparation for launching the EYEMATE system in the USA.