HumanInsight EYEMATE-SC Trial: 12-Month Safety, Performance and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure
Ophthalmology. 2022 Oct 3:S0161-6420(22)00760-6. doi: 10.1016/j.ophtha.2022.09.021. Online ahead of print.
BACKGROUND: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to better measure IOP throughout the entire day. The novel EYEMATE-SC sensor is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance and accuracy of the EYEMATE-SC in primary open-angle glaucoma (POAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).
METHODS: In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measures were compared with the sensors' IOP measures at all post-operative visits through 12 months. Device position and adverse events were recorded throughout the follow-up.
RESULTS: 15 eyes underwent canaloplasty and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation or serious device-related complications were recorded. A total of 536 EYEMATE-SC measures were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (limits of agreement (CI 95%, LoA): -5.1 and 6.7 mmHg). The agreement gradually improved and from 3-month post-operatively until the end of the follow-up, the mean difference was -0.2 mmHg (LoA: -4.6 and 4.2 mmHg) over a total of 264 EYEMATE-SC measures, and 100% of measures were within ± 5 mmHg of GAT.
CONCLUSIONS: The EYEMATE-SC sensor was safe and well-tolerated through 12 months. Moreover, it allowed accurate continuous IOP monitoring.
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