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拓普康KR-1W和iTrace获得的角膜屈光力测量的精密度(重复性和再现性)及一致性

Precision (Repeatability and Reproducibility) and Agreement of Corneal Power Measurements Obtained by Topcon KR-1W and iTrace.

作者信息

Hua Yanjun, Xu Zequan, Qiu Wei, Wu Qiang

机构信息

Department of Ophthalmology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, NO.600, Yishan Road, Xuhui District, Shanghai, 200233, China.

出版信息

PLoS One. 2016 Jan 11;11(1):e0147086. doi: 10.1371/journal.pone.0147086. eCollection 2016.

Abstract

PURPOSE

To evaluate the repeatability and reproducibility of corneal power measurements obtained by Topcon KR-1W and iTrace, and assess the agreement with measurements obtained by Allegro Topolyzer and IOLMaster.

METHODS

The right eyes of 100 normal subjects were prospectively scanned 3 times using all the 4 devices. Another observer performed additional 3 consecutive scans using the Topcon KR-1W and iTrace in the same session. About one week later, the first observer repeated the measurements using the Topcon KR-1W and iTrace. The steep keratometry (Ks), flat keratometry (Kf), mean keratometry (Km), J0 and J45 were analyzed. Repeatability and reproducibility of measurements were evaluated by the within-subject standard deviation (Sw), coefficient of variation (CoV), test-retest repeatability (2.77Sw), and intraclass correlation coefficient (ICC). Agreements between devices were assessed using Bland-Altman analysis and 95% limits of agreement (LoA).

RESULTS

Intraobserver repeatability and interobserver and intersession reproducibility of the Ks, Kf and Km showed a CoV of no more than 0.5%, a 2.77Sw of 0.70 D or less, and an ICC of no less than 0.99. However, J0 and J45 showed poor intraobserver repeatability and interobserver and intersession reproducibility (all ICCs not greater than 0.446). Statistically significant differences existed between Topcon KR-1W and IOLMaster, Topcon KR-1W and iTrace, Topcon KR-1W and Topolyzer, iTrace and Topolyzer, iTrace and IOLMaster for Ks, Kf and Km measurements (all P < 0.05). The mean differences between Topcon KR-1W, iTrace, and the other 2 devices were small. The 95% LoA were approximately 1.0 D to 1.5 D for all measurements.

CONCLUSIONS

The Ks, Kf and Km obtained by Topcon KR-1W and iTrace showed excellent intraobserver repeatability and interobserver and intersession reproducibility in normal eyes. The agreement between Topcon KR-1W and Topolyzer, Topcon KR-1W and IOLMaster, iTrace and Topolyzer, iTrace and IOLMaster, Topcon KR-1W and iTrace were not so good, they should not be interchangeable in clinical application. Given that the intraobserver repeatability and interobserver and intersession reproducibility of corneal astigmatism measurements obtained by Topcon KR-1W and iTrace were poor, it should be cautious that Topcon KR-1W and iTrace were applied for the preparation of toric lens implantation.

摘要

目的

评估使用拓普康KR - 1W和iTrace获得的角膜屈光力测量值的可重复性和再现性,并评估与使用Allegro Topolyzer和IOLMaster获得的测量值的一致性。

方法

对100名正常受试者的右眼使用所有4种设备进行前瞻性扫描3次。另一名观察者在同一时间段内使用拓普康KR - 1W和iTrace连续进行额外的3次扫描。大约一周后,第一名观察者使用拓普康KR - 1W和iTrace重复测量。分析了陡峭角膜曲率(Ks)、平坦角膜曲率(Kf)、平均角膜曲率(Km)、J0和J45。通过受试者内标准差(Sw)、变异系数(CoV)、重测重复性(2.77Sw)和组内相关系数(ICC)评估测量的可重复性和再现性。使用Bland - Altman分析和95%一致性界限(LoA)评估设备之间的一致性。

结果

Ks、Kf和Km的观察者内重复性以及观察者间和不同时间段的再现性显示CoV不超过0.5%,2.77Sw为0.70 D或更低,ICC不少于0.99。然而,J0和J45显示出较差的观察者内重复性以及观察者间和不同时间段的再现性(所有ICC均不大于0.446)。在Ks、Kf和Km测量中,拓普康KR - 1W与IOLMaster、拓普康KR - 1W与iTrace、拓普康KR - 1W与Topolyzer、iTrace与Topolyzer、iTrace与IOLMaster之间存在统计学显著差异(所有P < 0.05)。拓普康KR - 1W、iTrace与其他2种设备之间的平均差异较小。所有测量的95% LoA约为1.0 D至1.5 D。

结论

拓普康KR - 1W和iTrace获得的Ks、Kf和Km在正常眼中显示出优异的观察者内重复性以及观察者间和不同时间段的再现性。拓普康KR - 1W与Topolyzer、拓普康KR - 1W与IOLMaster、iTrace与Topolyzer、iTrace与IOLMaster、拓普康KR - 1W与iTrace之间的一致性不太好,它们在临床应用中不应互换。鉴于拓普康KR - 1W和iTrace获得的角膜散光测量的观察者内重复性以及观察者间和不同时间段的再现性较差,在应用拓普康KR - 1W和iTrace进行散光人工晶状体植入准备时应谨慎。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2670/4709181/5ddce2120fa6/pone.0147086.g001.jpg

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