Ophthalmic medical device company Implandata Ophthalmic Products GmbH (Implandata) announced it has completed enrolling participants for its international ARGOS-SC01 clinical study. This first-in-human clinical study is conducted to validate the suprachoroidally placed EYEMATE-SC sensor implant for continual monitoring of intraocular pressure (IOP).
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. In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE system provides actionable IOP measurements throughout 24 hours and outside the ophthalmologists office, enhancing treatment options and contributing to less progressing vision loss in glaucoma patients.
While Implandata’s already CE marked EYEMATE-IO intraocular sensor implant is intended for use at glaucoma patients undergoing cataract surgery, the EYEMATE-SC device allows implantation at 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 sensor is pleasantly small and easy to implant, so most patients undergoing glaucoma surgery are eligible for such a pressure sensor. This enables glaucoma patients for the first time to monitor their own eye pressure at any time. It will improve the safety for glaucoma patients and significantly reduce the risk of blindness due to glaucoma,” said lead investigator Dr. Peter Szurman from Eye Sulzbach at Knappschaft Hospital at Saar, Germany.
As the EYEMATE system provides direct feedback to the patient in a home setting - information previously unavailable to the patient - therapy adherence is expected to 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 the 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.
Full press release: https://www.b3cnewswire.com/202003022046/completion-of-study-enrolment-of-implandata-s-extraocular-eye-pressure-sensor-for-continual-glaucoma-monitoring.html