Keratograph眼表综合分析仪与传统方法对泪膜功能评价的一致性分析

Consistency analysis of Keratograph and traditional methods to evaluate tear film function

摘要:

目的：探讨一种最新的眼表综合分析仪Keratograph对于泪膜稳定性评估的重复性和准确性，将其测量值与传统的检查方法进行比较。

方法：采用Keratograph测量包括首次泪膜破裂时间(the first tear film break-up time， BUT-f)和平均泪膜破裂时间(the average tear film break-up time， BUT-ave)在内的非侵入式泪膜破裂时间(noninvasive tear film break-up time， NI_BUT)结果。测量结果的重复性使用变异系数(coefficient of variation，CV)和组内相关系数(intraclass correlation coefficient，ICC)进行评价， NI-BUT与传统的荧光素泪膜破裂时间(fluorescein tear film break-up time， FBUT)的比较采用Wilcoxon符号秩和检验，确定NI-BUT与FBUT，Schirmer Ⅰ试验结果的相关关系，采用Bland-Altman分析进行一致性评价。

结果：本研究纳入了48个受检者(48眼)，平均年龄38.7±15.2岁。BUT-f的CV和ICC分别为12.6%和0.95，BUT-ave的为9.8%和0.96。BUT-f值低于FBUT值，差异有统计学意义(6.16±2.46s vs 7.46±1.92s， P < 0.01)。NI-BUT与FBUT，Schirmer Ⅰ试验结果之间存在显著的正相关关系(P<0.01)。BUT-f与FBUT的95%一致性界限(limits of agreement， LoA)范围为4.46s，BUT-ave与FBUT的LoA范围为3.64s。

结论：Keratograph能够提供具有较好重复性和可靠性的NI-BUT数据，在干眼诊治和角膜屈光性手术等领域有很好的应用前景。

Abstract:

AIM: To investigate repeatability and accuracy of a latest Keratograph for evaluating the tear film stability and to compare its measurements with that of traditional examination methods.

METHODS: The results of noninvasive tear film break-up time(NI-BUT)including the first tear film break-up time(BUT-f)and the average tear film break-up time(BUT-ave)were measured by Keratograph. The repeatability of the measurements was evaluated by coefficient of variation(CV)and intraclass correlation coefficient(ICC). Wilcoxon Signed-Rank test was used to compare NI-BUT with fluorescein tear film break-up time(FBUT)to confirm the correlation between NI-BUT and FBUT, Schirmer I test values. Bland-Altman analysis was used to evaluate consistency.

RESULTS: The study recruited 48 subjects(48 eyes)(mean age 38.7±15.2 years). The CV and ICC of BUT-f were respectively 12.6% and 0.95, those of BUT-ave were 9.8% and 0.96. The value of BUT-f was lower than that of FBUT. The difference had statistical significance(6.16±2.46s vs 7.46±1.92s, P<0.01). There was significant positive correlation between NI-BUT and FBUT, Schirmer I test values(P<0.01). The scope of 95% limits of agreement(LoA)was 4.46s in BUT-f and FBUT, while the scope of LoA was 3.64s in BUT-ave and FBUT.

CONCLUSION: Keratograph can provide NI-BUT data that has a better repeatability and reliability, which has great application prospects in diagnosis and treatment of dry eye and refractive corneal surgery.