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可重复使用的 iCare Pro 眼压探头眼压测量准确性的比较分析。

A Comparative Analysis of Intraocular Pressure Measurement Accuracy With Reused iCare Probes.

机构信息

Department of Glaucoma, Sri Venkateswara Aravind Eye Hospital, Tirupati, India.

Department of Ophthalmology, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.

出版信息

Ophthalmol Glaucoma. 2024 Jul-Aug;7(4):352-358. doi: 10.1016/j.ogla.2024.02.005. Epub 2024 Feb 23.

DOI:10.1016/j.ogla.2024.02.005
PMID:38401758
Abstract

PURPOSE

To assess the accuracy of reused iCare probes after disinfection with 70% isopropyl alcohol and ethylene oxide gas compared to new iCare probes and Goldmann applanation tonometry (GAT).

DESIGN

Prospective comparative analysis.

PARTICIPANTS

A total of 118 eyes from 59 patients recruited from the Aravind Eye Hospital glaucoma clinic in Tirupati, South India.

METHODS

Intraocular pressure (IOP) was measured on each eye using a new iCare tonometer probe, an iCare probe previously used and disinfected 1 time prior (once used probe) and 5 times prior (multiply used probe), as well as with GAT. Probes were disinfected after each use with 70% isopropyl alcohol swabs and ethylene oxide sterilization.

MAIN OUTCOME MEASURES

Agreement demonstrated with intraclass correlation coefficients (ICCs), mean difference in IOP values with limits of agreement, and Bland-Altman plots among IOP measurement approaches.

RESULTS

Compared to new iCare probes, both once used probes (ICC = 0.989, 95% confidence interval [CI] 0.985-0.993) and multiply used probes (ICC = 0.989, 95% CI 0.984-0.992) showed excellent agreement, and the mean difference in IOP was minimal for both once used probes (0.70 mmHg, 95% CI 0.29-1.11) and multiply used probes (0.75 mmHg, 95% CI 0.66-0.82) compared to new probes. Bland-Altman plots demonstrated minimal differences between new and reused probes across the spectrum of IOP. When comparing multiply used probes to once used probes, there was a high level of agreement (0.993) (95% CI 0.990-0.995) and negligible mean IOP difference 0.04 mmHg (95% CI 0.32-0.40). Additionally, ICC values for new probes (0.966, 95% CI 0.951-0.976), once used probes (0.958, 95% CI 0.940-0.971), and multiply used probes (0.957, 95% CI 0.938-0.970) compared to GAT were similar and all showed excellent agreement. Both new and reused iCare probes underestimated IOP by 2 to 3 mmHg compared to GAT.

CONCLUSIONS

In this prospective comparative analysis, we found that reusing iCare probes up to 5 times does not compromise the accuracy of IOP measurements when disinfected with 70% isopropyl alcohol swabs and ethylene oxide. Reusing iCare probes has the potential to transform care by reducing cost, decreasing environmental waste, and allowing for glaucoma screening camps and increased glaucoma monitoring in low resource settings leading to earlier identification and treatment of glaucoma.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

摘要

目的

评估经 70%异丙醇和环氧乙烷气体消毒后重复使用的 iCare 探头与新 iCare 探头和 Goldmann 压平眼压计(GAT)相比的准确性。

设计

前瞻性比较分析。

参与者

共纳入来自印度南部蒂鲁帕蒂的 Aravind 眼科医院青光眼诊所的 59 名患者的 118 只眼睛。

方法

使用新的 iCare 眼压计探头、之前使用过且之前已消毒 1 次(使用过的探头)和 5 次(多次使用的探头)的 iCare 探头以及 GAT 对每只眼睛的眼压(IOP)进行测量。每次使用后,探头均用 70%异丙醇棉签和环氧乙烷消毒。

主要观察指标

采用组内相关系数(ICC)评估显示的一致性、IOP 值的平均差异及界限协议、以及 IOP 测量方法的 Bland-Altman 图。

结果

与新的 iCare 探头相比,使用过一次的探头(ICC=0.989,95%置信区间[CI]0.985-0.993)和多次使用的探头(ICC=0.989,95%CI0.984-0.992)均显示出极好的一致性,使用过一次的探头的 IOP 平均差异最小(0.70mmHg,95%CI0.29-1.11),多次使用的探头的 IOP 平均差异最小(0.75mmHg,95%CI0.66-0.82),与新探头相比。Bland-Altman 图显示新探头和重复使用探头在整个 IOP 范围内差异极小。当将多次使用的探头与使用过一次的探头进行比较时,高度一致(0.993)(95%CI0.990-0.995),IOP 差异可忽略不计,为 0.04mmHg(95%CI0.32-0.40)。此外,新探头(0.966,95%CI0.951-0.976)、使用过一次的探头(0.958,95%CI0.940-0.971)和多次使用的探头(0.957,95%CI0.938-0.970)与 GAT 的 ICC 值相似,均显示出极好的一致性。与 GAT 相比,新探头和重复使用的 iCare 探头均低估了 2 至 3mmHg 的 IOP。

结论

在这项前瞻性比较分析中,我们发现,经 70%异丙醇棉签和环氧乙烷消毒后,重复使用 iCare 探头多达 5 次不会影响 IOP 测量的准确性。重复使用 iCare 探头具有降低成本、减少环境废物、允许在资源匮乏的环境中开展青光眼筛查和增加青光眼监测的潜力,从而更早地发现和治疗青光眼。

金融披露

本文结尾的脚注和披露中可能存在专有或商业披露。

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