Aim To investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS). Methods Prospective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor’s safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tonometry (GAT). Results The eyes underwent canaloplasty (n=15) or deep sclerectomy (n=9) and achieved successful implantation of the sensor. No device migration, dislocation or serious device-related complications occurred. A total of 367 comparisons were included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 1.31 mm Hg (lower limit of agreement (LoA) 7.55 mm Hg; upper LoA –4.92 mm Hg). The maximum difference of 2.5 mm Hg ±3.96 (LoA 0.30–2.29) was reached on day 10 and continuously improved to an agreement of –0.15 mm Hg ±2.28 (LoA –1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of ±5 mm Hg improved from 78% (day 3) to 100% (6 months). Conclusions After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring. Trial registration number [NCT03756662][1]. Data may be obtained from a third party and are not publicly available. Not applicable. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03756662&atom=%2Fbjophthalmol%2F107%2F4%2F518.atom

中文翻译：

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EYEMATE-SC 试验中用于遥测眼压的脉络膜上膜传感器的安全性和性能

目的 研究遥测脉络膜上眼压 (IOP) 传感器 (EYEMATE-SC) 的安全性和性能及其在同时接受非穿透性青光眼手术 (NPGS) 的开角型青光眼 (OAG) 患者中测量 IOP 的准确性。方法 前瞻性、多中心、开放标签、单组、介入性临床试验。24 名 OAG 患者的 24 只眼睛定期接受 NPGS（球管成形术或深层巩膜切除术），同时植入了 EYEMATE-SC 传感器。对传感器的安全性和性能以及 EYEMATE-SC 测量值和 IOP 测量值与 Goldmann 压平眼压计 (GAT) 的一致性水平进行为期六个月的跟进。结果 15 只眼睛或 9 只眼睛接受了球管成形术，并成功植入了传感器。没有设备迁移，发生脱位或严重的器械相关并发症。IOP 协议分析中总共包含 367 项比较。GAT 和 EYEMATE-SC 测量值之间的总体平均差异为 1.31 mm Hg（一致性下限 (LoA) 7.55 mm Hg；LoA 上限 –4.92 mm Hg）。第 10 天达到 2.5 mm Hg ±3.96（LoA 0.30–2.29）的最大差异，并在 6 个月后持续改善至 –0.15 mm Hg ±2.28（LoA –1.24 至 0.89）的协议。因此，IOP 差异在 ±5 mm Hg 内的眼睛百分比从 78%（第 3 天）提高到 100%（6 个月）。结论 6 个月后，EYEMATE-SC 传感器安全且耐受性良好，可以持续监测 IOP。试用注册号[NCT03756662][1]。数据可能从第三方获得，并且不公开。不适用。[1]: