A Novel Contact Lens Sensor System for Continuous Intraocular Pressure Monitoring: Evaluation of Accuracy in Human Eyes

IF 3.2 Q1 OPHTHALMOLOGY
Yifan Wei MM , Yuning Zhang PhD , Zidong Chen PhD , Jones Iok-Tong Chong ME , Christopher Ching Hymn Lee PhD , Isuru Kaweendra Karunaratne PhD , Xinyi Zhang PhD , Mingjie Deng , Yangfan Yang MD, PhD , David C.C. Lam PhD , Minbin Yu MD, PhD
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Abstract

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 (P > 0.5). Contact lens sensor system IOP was higher than pre-CLS PAT and post-CLS GAT/PAT IOP in normal eyes (P < 0.01), and higher than pre-CLS GAT and post-CLS PAT in POAG/OHT eyes with normal IOP (P < 0.05). All IOP differences were within ± 2 mmHg. Intraclass correlation coefficient showed moderate to very strong consistency (0.51 ≤ r ≤ 0.95, P < 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 Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
一种用于连续眼内压监测的新型隐形眼镜传感器系统:人眼精度评估
目的评价新型隐形眼镜传感器系统(CLS)监测人眼眼压(IOP)的准确性。设计横断面研究。80名受试者共80只眼,分为3组:(1)正常眼40只;(2)原发性开角型青光眼(POAG)或高眼压(OHT)眼30只,IOP正常(<21 mmHg),其中POAG眼27只,OHT眼3只;(3)高IOP(≥21 mmHg)的POAG/OHT眼10只,其中POAG眼4只,OHT眼6只。方法受试者采用坐位和仰卧位,每个姿势保持10分钟,佩戴CLS连续监测IOP。在佩戴CLS前后,分别用Goldmann眼压计(GAT)和Perkins眼压计(PAT)测量受试者坐位时的眼压。主要观察指标:将CLS在坐位和仰卧位最后1分钟测量的平均IOP与CLS佩戴前后GAT和PAT测量的IOP进行比较。进行了类内相关系数分析和Bland-Altman分析。结果在POAG/OHT高IOP眼中,CLS前的GAT与正常眼的CLS无显著性差异(P >;0.5)。隐形眼镜传感器系统的IOP高于cls前PAT和cls后GAT/PAT的正常眼IOP (P <;0.01),且高于眼内压正常的POAG/OHT眼cls前的GAT和cls后的PAT (P <;0.05)。所有IOP差异均在±2 mmHg以内。类内相关系数表现出中等至非常强的一致性(0.51≤r≤0.95,P <;0.05),但POAG/OHT高IOP眼坐位CLS与坐位后GAT差异不显著。Bland-Altman分析显示,超过80%的点在±5 mmHg范围内,超过60%的点在±3 mmHg范围内。结论CLS在坐位和仰卧位、正常眼和POAG/OHT眼的IOP测量与压眼眼压测量具有良好的一致性,可用于相当准确的连续IOP监测。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Ophthalmology science
Ophthalmology science Ophthalmology
CiteScore
3.40
自引率
0.00%
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审稿时长
89 days
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