Out with the old and in with the new – there is a steady coming and going of fluid called aqueous humor in human eyes. But intraocular pressure rises if the amount of newly produced aqueous humor exceeds that of the draining fluid, which can permanently damage or even kill the optic nerve. This condition is called glaucoma.
People who are afflicted with this disease are generally unaware of the condition in the early stages. It goes unnoticed until it kills enough optic nerve cells to impair vision. Intraocular pressure (IOC) has to be brought down and kept in the normal range to prevent glaucoma from spreading and causing further damage. This can be done with medication, eye drops or, in advanced stages, with surgery. Choosing the right therapy is paramount when treating glaucoma. To this end, the treating physician has to know the pressure level in the eye and its fluctuation over time.
Prevailing measurement methods are poorly suited to gather enough data so as to reveal meaningful insights. 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, so the likelihood of these readings going undetected is very high. This increases the risk of a physician opting for the wrong therapy many times over.
Easy to use, accurate results
Scientists at Duisburg‘s Fraunhofer Institute for Microelectronic Circuits and Systems IMS have managed to solve this problem. “In a joint effort with Implandata Ophthalmic Products GmbH (Implandata) in Hanover, we developed EYEMATE, a microsensor system that enables patients to take contactless pressure measurements of their own eyes at any chosen frequency,” says Fraunhofer IMS’s Michael Görtz. A sensor implanted in the eye gauges pressure and temperature.
A hand-held reader records, digitizes and displays results; all the patient has to do is hold it in front of his or her eye. It takes the eye’s pressure and temperature readings in a matter of seconds – precisely, at any time and without touching the eye. With a data pool many times larger than what with conventional techniques can gather, attending physicians can apply the right therapy right away. The device’s readings can be downloaded, digitized and uploaded to cloud memory.
The attending physician can access patient data at any time to check and assess the disease’s progression and, if necessary, adjust the therapy on the spot. The patient no longer has to stop by the practice to this end. Patients may also access these data directly via a smartphone app, track their intraocular pressure readings and take the appropriate action if the pressure rising to alarming levels. The benefits increase with frequent application: the more often the patient uses the reader, the more meaningful the readings and the more personalized the therapy options.
Update December 2018:
Implandata announced that the first patient in its international, multi-center, ARGOS-SC01 clinical study has been successfully implanted with its novel pressure sensor. This first-in-human clinical study is being conducted to validate the suprachoroidally-placed EYEMATE-SC sensor implant for continual monitoring of IOP.
Principal Investigator, Prof. Peter Szurman of the Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach/Germany who performed the implantation of the EYEMATE-SC device in conjunction with non-penetrating glaucoma surgery stated: “The new 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.”
While Implandata’s already CE marked EYEMATE-IO intraocular sensor implant is intended for use in glaucoma patients undergoing cataract surgery, the EYEMATE-SC device allows implantation in glaucoma patients not indicated for cataract surgery yet, thus complementing Implandata’s product offering and expanding the indication of use of the EYEMATE-system. “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,” Max Ostermeier, CEO of Implandata commented.
In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE system provides actionable IOP measurements throughout 24 hours and outside the ophthalmologist’s office, enhancing treatment options and contributing to less progressing vision loss in glaucoma patients. As the EYEMATE system provides direct feedback to the patient in a home setting – information previously unavailable to the patient – therapy compliance will be improved, as it was already observed in earlier studies. Additionally, EYEMATE’s remote patient care capabilities will result in more efficient disease management, as number of office visits may be reduced for a considerable number of patients, while the eye doctor attains more and better information about the patient’s specific situation. Lastly, the aggregation of IOP measurement data may shed new light on the emergence and progression patterns of the disease, potentially unlocking new or more efficacious intervention approaches.