在EYEMATE-IO试验中，使用植入式传感器监测眼压检测结构性青光眼进展。

IF 4.1 1区医学 Q1 OPHTHALMOLOGY

American Journal of Ophthalmology Pub Date : 2025-05-12 DOI:10.1016/j.ajo.2025.05.010

Eleonora Micheletti,Harsha Rao,Robert N Weinreb,Kaweh Mansouri,

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引用次数: 0

摘要

目的和目的评价原发性开角型青光眼（POAG）患者眼压（IOP）测量值与视网膜神经纤维层（RNFL）同时变薄率之间的关系。本病例系列是前瞻性、开放标签、多中心介入性EYEMATE-SC试验的一部分。植入EYEMATE-IO传感器系统（Implandata, Hanover, Germany）的受试者、参与者和/或对照组被纳入为期3年的ARGOS-03随访研究。方法、干预或测试所有入组的患者间隔6个月至少进行5次光学相干断层扫描（OCT）检查，随访至少2年。使用EYEMATE-IO每天在一天的不同时间进行至少4次IOP测量。主要观察指标计算两次连续OCT检查期间EYEMATE-IO传感器测量的平均眼压、峰值眼压和眼压波动，并使用混合效应模型分析与OCT RNFL变薄的关系。分析了OCT访视当日Goldmann眼压计（GAT）测得的平均眼压与RNFL变薄的关系。结果8例使用EYEMATE-IO传感器的患者8只眼纳入分析。平均每位患者自我测量IOP次数为7283±5562次（范围1478 ~ 17247），平均随访时间为2.88±0.19年（范围2.43 ~ 3.01）。每位患者的平均OCT检查次数为6.38±0.74次（范围5 ~ 7次）。总体而言，随访期间RNFL变薄的平均速率为-0.62±1.06 um/年（P=0.274）。在线性混合效应模型分析中，使用EYEMATE-IO传感器测量的IOP峰值和IOP波动均与RNFL变薄显著相关（系数[95%CI]: -0.11 [-0.19;-0.34]， P=0.005和-0.76 [-1.31;-0.20]，P=0.007），而使用GAT测量的在岗平均IOP未发现关联（系数95%CI]: 0.04 [-0.12;0.20]， P=0.616）。结论使用EYEMATE-IO传感器测量的青光眼患者的speak IOP和IOP波动与疾病进展相关，而GAT测量的IOP波动与疾病进展无关。这些发现表明，使用植入式IOP传感器全天自我测量IOP可以预测青光眼的进展。

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Intraocular Pressure Monitoring Using An Implantable Sensor Detects Structural Glaucoma Progression in the EYEMATE-IO Trial.

OBJECTIVE AND PURPOSE To evaluate the association between intraocular pressure (IOP) measurements and concurrent rates of retinal nerve fiber layer (RNFL) thinning in primary open-angle glaucoma (POAG) eyes previously implanted with a sulcus-based IOP sensor. DESIGN This case series is part of the prospective, open-label, multicenter interventional EYEMATE-SC trial. SUBJECTS, PARTICIPANTS, AND/OR CONTROLS Patients implanted with the EYEMATE-IO sensor system (Implandata, Hanover, Germany) were enrolled in the 3 years' ARGOS-03 follow-up study. METHODS, INTERVENTION, OR TESTING All patients enrolled had at least five optical coherence tomography (OCT) examinations six-months apart with minimum two years follow-up. A minimum of 4 IOP measurements daily at different times of the day were obtained with the EYEMATE-IO. MAIN OUTCOME MEASURES Mean IOP, peak IOP, and fluctuation of IOP measured by EYEMATE-IO sensor during the period between two consecutive OCT examinations were calculated and the relationship with OCT RNFL thinning was analyzed using mixed effects models. The relationship of mean IOP measured by Goldmann applanation tonometry (GAT) on the day of OCT visit with RNFL thinning was also analyzed. RESULTS Eight eyes of 8 patients with the EYEMATE-IO sensor were included in the analysis. The mean number of self-measurements of IOP per patient was 7283 ± 5562 (range 1478 to 17247), with a mean follow-up time of 2.88 ± 0.19 years (range 2.43 to 3.01). The mean number of OCT examinations per patient was 6.38 ± 0.74 (range 5 to 7). Overall, the mean rate of RNFL thinning during the follow-up was -0.62 ± 1.06 um/year (P=0.274). In the linear mixed-effects model analysis, both peak IOP and IOP fluctuations measured using the EYEMATE-IO sensor were significantly associated with RNFL thinning (coefficient [95%CI]: -0.11 [-0.19;-0.34], P=0.005 and -0.76 [-1.31;-0.20], P=0.007, respectively), whereas no association was found for in-office mean IOP measured by GAT (coefficient 95%CI]: 0.04 [-0.12;0.20], P=0.616). CONCLUSIONS Peak IOP and IOP fluctuations in glaucoma patients derived from measurements with the EYEMATE-IO sensor were associated with progression of the disease, whereas GAT measurements were not. These findings suggest that self-measurements of IOP throughout the day with an implantable IOP sensor can predict glaucoma progression.

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来源期刊

American Journal of Ophthalmology 医学-眼科学

CiteScore

9.20

自引率

7.10%

发文量

406

审稿时长

36 days

期刊介绍： The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect. The American Journal of Ophthalmology publishes Full-Length Articles, Perspectives, Editorials, Correspondences, Books Reports and Announcements. Brief Reports and Case Reports are no longer published. We recommend submitting Brief Reports and Case Reports to our companion publication, the American Journal of Ophthalmology Case Reports. Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical problems with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors.