国产与进口Scheimpflug成像技术原理的眼前节生物分析系统测量中央角膜厚度和角膜曲率的对比分析

doi:10.3760/cma.j.cn115909-20210528-00221

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摘要目的：比较国产Scansys（上海美沃公司）与进口Pentacam（德国Oculus公司）的Scheimpflug成像技术原理的眼前节生物分析系统测量近视患者中央角膜厚度（CCT）和角膜曲率的一致性和差异性。方法：系列病例研究。纳入2020年6─7月在河南省立眼科医院屈光中心就诊的拟行角膜屈光手术的近视患者100例（100眼），年龄17～35（23.5±5.3）岁，术前等效球镜度为-10.50～-2.00 D，除近视外无其他眼部疾病，依次接受Scansys和Pentacam眼前节分析系统检查，每只眼重复测量3次，记录中央角膜厚度和角膜曲率，仅取右眼数据进行分析。2种仪器测量CCT和角膜曲率的重复性比较采用组内相关系数（ICC）、变异系数（CoV）、组内标准差（Sw）、重复性限（2.77Sw）、重复测量方差分析和Bland-Altman 分析法评估，而差异性、相关性和一致性的比较分别采用配对t检验、Pearson相关系数和Bland-Altman 分析法实施。结果：Scansys和Pentacam重复3次测量CCT和角膜曲率（K1、K2、Km）的ICC均大于0.99， Sw和2.77Sw均较小，CoV均小于1%。重复测量方差分析差异均无统计学意义，进一步的Bonferroni矫正结果显示任意2次的检测差异均无统计学意义。Bland-Altman分析结果显示重复测量的任意2次检测结果之间的95%一致性界限（LoA）范围均较窄。Pearson相关分析结果显示2种仪器测量CCT和角膜曲率的结果均呈正线性相关（均r>0.97，均P<0.05）。配对t检验结果显示Scansys和Pentacam测量CCT、K1、 K2、Km差异均无统计学意义。2种仪器测量CCT、K1、K2、Km的95%LoA分别为-4.26～11.26 μm、 -0.48～0.55 D、-0.52～0.69 D、-0.45～0.57 D。结论：Scansys测量CCT和角膜曲率数据具有很好的重复性，与Pentacam测量结果相比差异较小，相关性和一致性均较好，可相互参考替代。

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关键词 ： Scheimpflug, 生物测量/眼, 中央角膜厚度, 角膜曲率, 重复性, 一致性

Abstract：Objective: To compare the repeatability, differentiation and agreement of measurements of central corneal thickness (CCT) and keratometry from myopic patients using the domestic Scansys (Meiwo company in Shanghai, China)and the imported Pentacam (Oculus, Germany) anterior segment analysis system using the Scheimpflug technique. Methods: In this case series study, 100 patients (100 eyes) who underwent pre-operative examinations for refractive surgery were recruited in the refraction center of Henan Provincial Eye Hospital from June to July 2020. Average age was 17-35(23.5±5.3) years, with spherical equivalents from -10.50 D to -2.00 D. The subjects were myopic without any other eye disease. Measurements were obtained first with Scansys and then with Pentacam. Examinations were repeated three times for each eye, and CCT and keratometry (K1, K2, Km) were recorded. The data of the right eyes were analyzed. Interclass correlation coefficient (ICC), coefficient of variation (CoV), within-subject standard deviation (Sw), repeatability limit of the standard deviation (2.77Sw), repeated measures analysis of variance (RMANOVA) and Bland-Altman analysis were used to evaluate the repeatability of the two devices measuring CCT and keratometry, while paired t-test, Pearson correlation coefficient and BlandAltman plots were used to compare the differentiation, correlation and agreement between Scansys and Pentacam. Results: The ICC of repeated measurements were all greater than 0.99, and the values of Sw and 2.77Sw were relatively low with CoV all below 1%. No statistically significant difference was found with RMANOVA. Further Bonferroni correction results showed that the P value was 1.000 for any two tests, and the difference was not statistically significant. The results of Bland-Altman analysis showed that the 95% limits of agreement (LoA) between every two examinations was narrow. Pearson correlation analysis showed that CCT and keratometry were highly related between the two instruments (all r>0.97, all P<0.05). The results of the paired t-test showed that there were no significant differences in CCT, K1, K2 and KM measured by Scansys and Pentacam. The 95% LoA of CCT, K1, K2, Km measured with the two instruments was -4.26-11.26 μm, -0.48-0.55 D, -0.52-0.69 D, -0.45-0.57 D, respectively. Conclusions: Scansys shows excellent repeatability of CCT and keratometry measurements. Moreover, the values acquired from Scansys reflect good correlation and agreement with Pentacam. The difference was small compared to Pentacam, so it can be substituted by mutual reference.

Key words： Scheimpflug biometric/eye central corneal thickness keratometry repeatability agreement

收稿日期: 2021-05-28

PACS:

基金资助: 郑州市科技惠民计划项目（2020KJHM0015）

通讯作者: 庞辰久（ORCID：000-0001-8499-3748），Email：pangcj999@sohu.com

引用本文:

王浩王闯张波王树林李金顾宇伟宋鹏庞辰久. 国产与进口Scheimpflug成像技术原理的眼前节生物分析系统测量中央角膜厚度和角膜曲率的对比分析[J]. 中华眼视光学与视觉科学杂志, 2021, 23(10): 752-758. Hao Wang, Chuang Wang, Bo Zhang, Shulin Wang, Jin Li, Yuwei Gu, Peng Song, Chenjiu Pang. Comparison of Central Corneal Thickness and Keratometry Measured by Domestic and Imported Optical Anterior Segment Analysis Systems Using the Scheimpflug Technique. Chinese Journal of Optometry Ophthalmology and Visual science, 2021, 23(10): 752-758. DOI: 10.3760/cma.j.cn115909-20210528-00221

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https://www.cjoovs.com/CN/10.3760/cma.j.cn115909-20210528-00221 或 https://www.cjoovs.com/CN/Y2021/V23/I10/752

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