一种用于连续眼压监测的新型隐形眼镜传感器系统：安全性和耐受性评估。
A New Contact Lens Sensor System for Continuous Intraocular Pressure Monitoring: Evaluation of Safety and Tolerability.
机构信息
State Key Laboratory of Ophthalmology (Y.Z., Y.W., M.D., Z.C., Y.Y., M.Y.), 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; and Department of Mechanical and Aerospace Engineering (I.K.K., C.H.C.L., I.T.C., D.C.C.L.), The Hong Kong University of Science and Technology, Hong Kong, China.
出版信息
Eye Contact Lens. 2022 Oct 1;48(10):439-444. doi: 10.1097/ICL.0000000000000926. Epub 2022 Aug 12.
PURPOSE
To assess the safety and tolerability of a new contact lens sensor (CLS) system for continuous 3- and 24-hr intraocular pressure (IOP) monitoring in human eyes.
METHODS
Twenty-five subjects were recruited for 3-hr IOP measurement by CLS. Corneal fluorescein staining (CFS) scores were evaluated before and after measurement. Then, 30 participants (10 normal subjects and 20 glaucoma patients) were recruited for 24-hr IOP monitoring. Ocular surface disease index (OSDI) was assessed before and one day after measurement. Contact lens dry eye questionnaire-8 was assessed immediately after measurement. Visual analog scale of discomfort was measured before, immediately after, and one day after measurement. Best-corrected visual acuity (BCVA), tear break-up time (TBUT), and CFS were assessed before, immediately after, and 1 day after measurement.
RESULTS
All participants completed 3- or 24-hr IOP measurement by CLS. Corneal fluorescein staining increased from 0.6±0.7 to 2.4±1.5 after 3-hr IOP measurement ( P <0.001). For participants undergoing 24-hr IOP monitoring, OSDI increased from 9.1±9.7 to 18.0±12.4 ( P =0.001). CLDEQ-8 score was 11.6±5.8. Visual analog scale increased from 11.1±14.2 to 35.2±21.8 after measurement ( P <0.001) and decreased to 26.7±18.4 one day later ( P <0.001 compared with baseline). BCVA decreased from 1.0±0.01 to 0.8±0.1 ( P <0.001) and returned to 0.9±0.1 after one day ( P <0.001 compared with baseline). TBUT decreased from 5.1±3.9 to 2.6±1.5 s ( P =0.001) and returned to 4.8±2.5 s ( P =0.465 compared with baseline). Corneal fluorescein staining increased from 0.7±0.9 to 4.3±0.8 ( P <0.001) and dropped to 0.8±0.7 ( P =0.599 compared with baseline). No significant difference was found for all variations of indicators between normal subjects and glaucoma patients ( P >0.1 for all comparisons).
CONCLUSIONS
The CLS shows a great potential for a safe and tolerable 24-hr IOP monitoring in normal subjects and glaucoma patients. Clinical attention to the worsening signs and symptoms after measurement is required.
目的
评估一种新的接触镜传感器（CLS）系统用于人类眼睛连续 3 小时和 24 小时眼压（IOP）监测的安全性和耐受性。
方法
招募了 25 名受试者进行 CLS 的 3 小时 IOP 测量。在测量前后评估角膜荧光素染色（CFS）评分。然后，招募了 30 名参与者（10 名正常受试者和 20 名青光眼患者）进行 24 小时 IOP 监测。在测量前后评估眼表疾病指数（OSDI）。在测量后立即评估接触镜干眼症问卷-8。在测量前、测量后立即和测量后 1 天测量视觉模拟量表的不适程度。在测量前后立即、测量后 1 天评估最佳矫正视力（BCVA）、泪膜破裂时间（TBUT）和 CFS。
结果
所有参与者均完成了 CLS 的 3 小时或 24 小时 IOP 测量。角膜荧光素染色从 0.6±0.7 增加到 2.4±1.5（P<0.001）。对于接受 24 小时 IOP 监测的参与者，OSDI 从 9.1±9.7 增加到 18.0±12.4（P=0.001）。CLDEQ-8 评分为 11.6±5.8。视觉模拟量表评分从测量后的 11.1±14.2 增加到 35.2±21.8（P<0.001），1 天后降至 26.7±18.4（P<0.001 与基线相比）。BCVA 从 1.0±0.01 下降到 0.8±0.1（P<0.001），1 天后恢复到 0.9±0.1（P<0.001 与基线相比）。TBUT 从 5.1±3.9 下降到 2.6±1.5 s（P=0.001），并恢复到 4.8±2.5 s（P=0.465 与基线相比）。角膜荧光素染色从 0.7±0.9 增加到 4.3±0.8（P<0.001），并降至 0.8±0.7（P=0.599 与基线相比）。正常受试者和青光眼患者之间的所有指标变化均无显著差异（所有比较的 P>0.1）。
结论
CLS 显示出在正常受试者和青光眼患者中进行安全和耐受的 24 小时 IOP 监测的巨大潜力。需要注意测量后症状和体征的恶化。
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