一种用于连续眼压监测的新型隐形眼镜传感器系统：在人眼中的准确性评估。
A Novel Contact Lens Sensor System for Continuous Intraocular Pressure Monitoring: Evaluation of Accuracy in Human Eyes.
作者信息
Wei Yifan, Zhang Yuning, Chen Zidong, Chong Jones Iok-Tong, Lee Christopher Ching Hymn, Karunaratne Isuru Kaweendra, Zhang Xinyi, Deng Mingjie, Yang Yangfan, Lam David C C, Yu Minbin
机构信息
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.
Department of Mechanical and Aerospace Engineering, The Hong Kong University of Science and Technology, Kowloon, Hong Kong, China.
出版信息
Ophthalmol Sci. 2025 May 12;5(5):100826. doi: 10.1016/j.xops.2025.100826. eCollection 2025 Sep-Oct.
PURPOSE
To evaluate the accuracy of intraocular pressure (IOP) monitoring by a novel contact lens sensor system (CLS) in human eyes.
DESIGN
Cross sectional study.
PARTICIPANTS
Eighty eyes of 80 participants were recruited and divided into 3 groups: (1) 40 normal eyes; (2) 30 eyes with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) with normal IOP (<21 mmHg), including 27 POAG eyes and 3 OHT eyes; and (3) 10 POAG/OHT eyes with high IOP (≥21 mmHg), comprising 4 POAG eyes and 6 OHT eyes.
METHODS
Participants wore the CLS to enable continuous monitoring of IOP while they assumed both seated and supine positions, with each position maintained for 10 minutes. Intraocular pressure was also measured by the Goldmann applanation tonometer (GAT) while participants were seated and the Perkins applanation tonometer (PAT) in supine, both before and after CLS wear.
MAIN OUTCOME MEASURES
The average IOP measured by CLS during the final 1-minute of seated and supine positions was compared with IOP measured by GAT and PAT before and after CLS wear. Also, intraclass correlation coefficient and Bland-Altman analyses were performed.
RESULTS
No significant differences were found between pre-CLS GAT and CLS in normal eyes or between all comparisons in POAG/OHT eyes with high IOP ( > 0.5). Contact lens sensor system IOP was higher than pre-CLS PAT and post-CLS GAT/PAT IOP in normal eyes ( < 0.01), and higher than pre-CLS GAT and post-CLS PAT in POAG/OHT eyes with normal IOP ( < 0.05). All IOP differences were within ± 2 mmHg. Intraclass correlation coefficient showed moderate to very strong consistency (0.51 ≤ ≤ 0.95, < 0.05) except for that between sitting CLS and post-CLS GAT in POAG/OHT eyes with high IOP. Bland-Altman analysis showed that over 80% of points were within ± 5 mmHg and over 60% within ± 3 mmHg.
CONCLUSIONS
With good agreement in IOP measurement compared with applanation tonometry in seated and supine positions, across normal and POAG/OHT eyes, the CLS can be used for fairly accurate continuous IOP monitoring.
FINANCIAL DISCLOSURES
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的
评估一种新型隐形眼镜传感器系统（CLS）在人眼内监测眼压（IOP）的准确性。
设计
横断面研究。
参与者
招募了80名参与者的80只眼睛，分为3组：（1）40只正常眼睛；（2）30只原发性开角型青光眼（POAG）或眼压高（OHT）且眼压正常（<21 mmHg）的眼睛，包括27只POAG眼睛和3只OHT眼睛；（3）10只眼压高（≥21 mmHg）的POAG/OHT眼睛，包括4只POAG眼睛和6只OHT眼睛。
方法
参与者佩戴CLS，以便在他们处于坐姿和仰卧位时连续监测眼压，每个姿势保持10分钟。在佩戴CLS前后，当参与者坐着时用Goldmann压平眼压计（GAT）测量眼压，仰卧时用Perkins压平眼压计（PAT）测量眼压。
主要观察指标
将CLS在坐姿和仰卧位最后1分钟测量的平均眼压与佩戴CLS前后GAT和PAT测量的眼压进行比较。此外，还进行了组内相关系数和Bland-Altman分析。
结果
在正常眼睛中，CLS佩戴前的GAT与CLS之间以及眼压高的POAG/OHT眼睛的所有比较之间均未发现显著差异（>0.5）。在正常眼睛中，隐形眼镜传感器系统测量的眼压高于CLS佩戴前的PAT以及CLS佩戴后的GAT/PAT测量的眼压（<0.01），在眼压正常的POAG/OHT眼睛中高于CLS佩戴前的GAT和CLS佩戴后的PAT（<0.05）。所有眼压差异均在±2 mmHg范围内。组内相关系数显示出中度至非常强的一致性（0.51≤≤0.95，<0.05），眼压高的POAG/OHT眼睛中坐姿CLS与CLS佩戴后的GAT之间除外。Bland-Altman分析表明，超过80%的点在±5 mmHg范围内，超过60%在±3 mmHg范围内。
结论
与坐位和平卧位的压平眼压测量相比，CLS在正常眼睛和POAG/OHT眼睛中眼压测量具有良好的一致性，可用于相当准确的连续眼压监测。
财务披露
本文末尾的脚注和披露中可能会有专有或商业披露。
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