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使用乳胶和聚乙烯包装的 Tono-Pen 探头盖进行眼内测量的重复性、可再现性、一致性和安全性。

Repeatability, reproducibility, agreement, and safety of Tono-Pen tip cover for intraocular measurement using latex and polyethylene wrap.

机构信息

Department of Ophthalmology, Glaucoma Research Unit, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Department of Ophthalmology, Glaucoma Unit, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.

出版信息

PLoS One. 2020 Sep 28;15(9):e0239875. doi: 10.1371/journal.pone.0239875. eCollection 2020.

DOI:10.1371/journal.pone.0239875
PMID:32986771
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7521710/
Abstract

PURPOSE

To evaluate repeatability, reproducibility, and agreement of intraocular pressure measurement with Tono-Pen using Ocufilm and polyethylene wrap tip cover in human eyes.

METHODS

This is a cross-sectional, experimental study. A gas-sterilized, polyethylene wrap was used as an alternative for Tono-Pen tip cover. For the right eye, 4 measurements using polyethylene wrap tip cover were done by two examiners (A and B) in random order to assess intra-observer repeatability and inter-observer reproducibility. For the left eye, 4 measurements were done by examiner A using both polyethylene wrap tip cover and Ocufilm in random order to assess intra-observer repeatability and agreement. Bland-Altman plot and intraclass correlation coefficient (ICC) were used in all analyses. Cost minimization analysis was evaluated.

RESULTS

For examiner A, the repeatability of polyethylene wrap tip cover was -0.34, 95% limits of agreement (LOA) were -3.04 to 2.36, and ICC was 0.93 in the right eyes. As for the left eyes, the repeatability of polyethylene wrap tip cover was -0.33, 95% LOA were -3.01 to 2.36, and ICC was 0.93. For examiner B, the repeatability of polyethylene wrap tip cover was -0.02, 95% LOA were -2.88 to 2.83, and ICC was 0.92. The inter-observer reproducibility of polyethylene wrap tip cover was 0.36, 95% LOA were -3.34 to 4.07, and ICC was 0.90. The repeatability of Ocufilm was -0.42, 95% LOA were -2.75 to 1.91, and ICC was 0.95. The agreement of polyethylene wrap tip cover and Ocufilm was -0.71, 95% LOA were -5.18 to 3.76, and ICC was 0.83. There were no allergic reactions or serious complications. From the cost minimization analysis, the local cost for polyethylene tip cover was approximately 8 times lower compared to Ocufilm.

CONCLUSIONS

Tono-pen with Ocufilm and polyethylene wrap tip cover were used to measure the intraocular pressure. The polyethylene wrap tip cover demonstrated acceptable repeatability, reproducibility, and agreement with Ocufilm in normotensive eyes, and had a good safety profile.

摘要

目的

评估使用 Ocufilm 和聚乙烯包裹探头盖的 Tono-Pen 在人眼中测量眼压的重复性、再现性和一致性。

方法

这是一项横断面、实验性研究。使用经过气体消毒的聚乙烯包裹物作为 Tono-Pen 探头盖的替代品。对于右眼,由两位检查者(A 和 B)以随机顺序进行 4 次聚乙烯包裹探头盖测量,以评估观察者内重复性和观察者间再现性。对于左眼,检查者 A 以随机顺序使用聚乙烯包裹探头盖和 Ocufilm 进行 4 次测量,以评估观察者内重复性和一致性。所有分析均使用 Bland-Altman 图和组内相关系数(ICC)。评估了成本最小化分析。

结果

对于检查者 A,聚乙烯包裹探头盖的重复性为-0.34,95%置信区间(LOA)为-3.04 至 2.36,右眼的 ICC 为 0.93。对于左眼,聚乙烯包裹探头盖的重复性为-0.33,95% LOA 为-3.01 至 2.36,ICC 为 0.93。对于检查者 B,聚乙烯包裹探头盖的重复性为-0.02,95% LOA 为-2.88 至 2.83,ICC 为 0.92。聚乙烯包裹探头盖的观察者间再现性为 0.36,95% LOA 为-3.34 至 4.07,ICC 为 0.90。Ocufilm 的重复性为-0.42,95% LOA 为-2.75 至 1.91,ICC 为 0.95。聚乙烯包裹探头盖和 Ocufilm 的一致性为-0.71,95% LOA 为-5.18 至 3.76,ICC 为 0.83。没有过敏反应或严重并发症。从成本最小化分析来看,与 Ocufilm 相比,聚乙烯探头盖的本地成本约低 8 倍。

结论

使用 Tono-Pen 和 Ocufilm 及聚乙烯包裹探头盖测量眼压。在正常眼压眼中,聚乙烯包裹探头盖与 Ocufilm 具有可接受的重复性、再现性和一致性,且具有良好的安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/d4422ac7edc0/pone.0239875.g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/a4f180339579/pone.0239875.g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/b3dd68168ffd/pone.0239875.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/3562363025bd/pone.0239875.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/340fc0b2542c/pone.0239875.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/ff453de57559/pone.0239875.g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/1486a4b1f4f5/pone.0239875.g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/4f99135f7d9b/pone.0239875.g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/d4422ac7edc0/pone.0239875.g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/a4f180339579/pone.0239875.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/37b7ce50eda2/pone.0239875.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/b3dd68168ffd/pone.0239875.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/3562363025bd/pone.0239875.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/340fc0b2542c/pone.0239875.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/ff453de57559/pone.0239875.g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/1486a4b1f4f5/pone.0239875.g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/4f99135f7d9b/pone.0239875.g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f37/7521710/d4422ac7edc0/pone.0239875.g009.jpg

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