EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure

Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) 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 patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS).

中文摘要

目前測量眼壓的參考技術Goldmann applanation tonometry, GAT在技術訓練及受檢者依賴上有所限制，且不易偵測到真正的峰值和低谷，也無法長期測量眼壓。因此，無法完全掌握眼壓變化，進而影響臨床醫師對青光眼診斷與治療的決策。自我測量眼壓因具有不受受檢者地點與時間的限制，因此，已被提出作為替代方案。文章介紹了一種小型化的眼壓感測器(EYEMATE-SC, implanted in the suprachoroidal space )，它能夠在手持式讀取器的幫助下實現wireless持續性的測量眼壓，以取代現行的眼壓測量技術。透過實驗證明這種感測器經植入後，在12個月的追蹤期間沒有發生裝置移位、翻轉或嚴重的裝置相關併發症。所有病人在使用自我測量的閱讀單元時都被鼓勵在家中定期測量眼壓，並在不同時間進行測量。自我測量的IOP readings對青光眼的患者能夠有效提升治療效果，因此這種新的感測器對青光眼患者的管理和追蹤，以及患者治療效果的評估都有很大的幫助。

English Abstract

The measurement and control of intraocular pressure (IOP) are essential in the treatment of glaucoma. Goldmann applanation tonometry (GAT) is currently the reference technique, but it has limitations due to its dependence on trained personnel and specialized equipment. Telemetric IOP self-measurement offers several advantages over traditional tonometry. The EYEMATE-SC sensor was developed for implantation into the suprachoroidal space, enabling wireless on-demand measurement of continuous IOP values via an external handheld reader. In this first-in-human, prospective, open-label, single-arm, multi-center clinical investigation, 24 patients with primary open-angle glaucoma were enrolled to assess the safety, tolerability, and performance of the EYEMATE-SC suprachoroidal pressure sensor system. 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. The overall mean measurement difference between GAT and EYEMATE-SC was 0.8 mmHg, and the 95% confidence interval of limits of agreement was -5.1 to 6.7 mmHg. The EYEMATE-SC sensor was safe and well-tolerated through 12 months, and no serious complications or sensor migration were observed during the follow-up period. These findings suggest that the EYEMATE-SC may provide a reliable and reproducible alternative to traditional IOP measurement techniques.