EYEMATE-SC试验：用于眼压遥测测量的脉络膜上腔传感器的12个月安全性、性能和准确性
EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure.
作者信息
Szurman Peter, Gillmann Kevin, Seuthe Anna-Maria, Dick H Burkhard, Hoffmann Esther M, Mermoud Andre, Mackert Marc J, Weinreb Robert N, Rao Harsha L, Mansouri Kaweh
机构信息
Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, Germany; Klaus Heimann Eye Research Institute, Sulzbach, Germany.
Glaucoma Research Center, Montchoisi Clinic, Swiss Visio, Lausanne, Switzerland; Glaucoma Services, Moorfields Eye Hospital, London, United Kingdom; Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California.
出版信息
Ophthalmology. 2023 Mar;130(3):304-312. doi: 10.1016/j.ophtha.2022.09.021. Epub 2022 Oct 3.
PURPOSE
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).
DESIGN
Prospective, multicenter, open-label, single-arm, interventional clinical trial.
PARTICIPANTS
Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy).
METHODS
An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months.
MAIN OUTCOME MEASURES
Device position and adverse events.
RESULTS
Fifteen 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 measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements 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.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
目的
测量和控制眼压是青光眼治疗的基础。自我眼压测量法已被提议作为一种能更好地全天测量眼压的替代方法。新型EYEMATE-SC传感器（Implandata）植入脉络膜上腔，以实现非接触式连续眼压监测。本研究的目的是调查EYEMATE-SC在接受同期非穿透性青光眼手术（NPGS）的原发性开角型青光眼患者中的1年安全性、性能和准确性。
设计
前瞻性、多中心、开放标签、单臂干预性临床试验。
参与者
24例因计划接受NPGS（房角成形术或深层巩膜切除术）的原发性开角型青光眼患者的24只眼睛。
方法
在NPGS期间植入EYEMATE-SC传感器。在术后所有随访中，将Goldmann压平眼压测量法（GAT）测量结果与传感器的眼压测量结果进行比较，随访期为12个月。
主要观察指标
装置位置和不良事件。
结果
15只眼睛接受了房角成形术，9只眼睛接受了深层巩膜切除术。所有眼睛均成功植入传感器，未报告术中困难。在12个月的随访中，未记录到装置移位、脱位或与装置相关的严重并发症。共有536次EYEMATE-SC测量结果被纳入眼压一致性分析。GAT与EYEMATE-SC测量结果之间的总体平均差异为0.8 mmHg（一致性界限[LoA]的95%置信区间[CI]，-5.1至6.7 mmHg）。一致性逐渐改善，从术后3个月到随访结束，在总共264次EYEMATE-SC测量中，平均差异为-0.2 mmHg（LoA的95%CI，-4.6至4.2 mmHg），100%的测量结果在GAT的±5 mmHg范围内。
结论
EYEMATE-SC传感器在12个月内安全且耐受性良好。此外，它还能实现准确、连续的眼压监测。
财务披露
专有或商业披露信息可在参考文献之后找到。
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