German medical device company Implandata has received CE Marking for EyeMate, the first approved IOP-monitoring system to offer 24-hour pressure measurements in patients with primary open-angle glaucoma (POAG).
Implanted into the ciliary sulcus during cataract surgery, the system is run by a permanent, battery-free 11.2-mm round microsensor powered by electromagnetic inductive coupling.
The sensor consists of eight pressure-sensitive capacitors and a circular microcoil antenna, which is coupled to an external handheld unit that displays readings to the patient and sends real-time data to the physician over the internet. An associated smartphone app can be used to display IOP history and set medication alerts.
Currently, the system is designed and indicated for use only in aphakic POAG patients, though in the future the company hopes to expand to patients undergoing corneal transplants.
“Based on our clinical experience with the EyeMate system, it can be well handled by the ophthalmic surgeon. The device can be safely implanted in the sulcus during normal cataract surgery and has proven to be highly beneficial for both the clinician as well as the patient,” said Hagen Thieme, MD, principal investigator for the device’s preapproval clinical trial, ARGOS-02.
The EyeMate does have its drawbacks, including the need for a larger incision than what is typically required for cataract surgery alone. Investigators also encountered challenges when testing the implant in eyes with narrow pupils.
“Design optimization has been started to allow usual incision sizes and easy implantation also in challenging eyes, allowing broad adoption of the product,” said clinical trial team member H. Burkhard Dick, MD, PhD.
Findings from the previous ARGOS-01 trial—which assessed the system in 6 POAG eyes—showed that the daily IOP fluctuation patterns measured by EyeMate may gradually drift from those obtained by Goldmann applanation tonometry (GAT). After 5 to 6 months, the EyeMate measured 3 patients with significant increases in circadian IOP curves and 1 with a significant decrease, all while GAT readings remained stable.
The safety results were promising, however, with all patients maintaining controllable glaucoma at 1 year post-implantation. There was also no incidence of endothelial cell loss, pupillary block, angle closure, corneal edema, retinal detachment, endophthalmitis, bleeding, macular edema or visual deterioration.
Detailed safety and efficacy data from the larger ARGOS-2 trial, including correlation with GAT, is not yet publicly available.