de Sanctis Ugo, Machetta Federica, Razzano Luca, Dalmasso Paola, Grignolo Federico M
Department of Clinical Physiopathology, Turin University, Italy.
Cornea. 2006 Jun;25(5):501-6. doi: 10.1097/01.ico.0000214217.83119.af.
Noncontact specular microscopes and semiautomated methods of endothelial analysis are widely used in the clinical practice and for research purposes. In this study, the interexaminer reproducibility between two noncontact specular microscopes using different semiautomated methods was assessed in normal corneas.
Average cell size (ACS), endothelial cell density (ECD), coefficient of variation (CV), and hexagonality values were independently calculated by two examiners with the Topcon SP 2000P Image-NET retraced method and the Konan CC7000 center method in 49 normal subjects. Interexaminer reproducibility and correlation between instruments/methods were assessed through 95% limits of agreement, intra-class correlation coefficient (ICC), Pearson correlation coefficient, and Spearman rank test.
Interexaminer reproducibility was good for ACS and ECD measurements (ICC > 0.85) but weak for CV and hexagonality (ICC < 0.65). Significantly higher ACS and lower ECD values (P < 0.05) were obtained with the Topcon in comparison with the Konan method by both examiners. ACS and ECD mean differences were respectively, +26 microm2 and -184 cell/mm2 for examiner 1 and +36 microm2 and -228 cell/mm2 for examiner 2. No significant difference (P > 0.05) between instruments/methods was found in CV or hexagonality values; however, the correlation for these parameters was low (r < 0.20).
Either instrument or method allows reproducible and accurate ACS and ECD measurements on normal corneas, but the difference between the two instruments is systematic and significant. The difference found were not clinically meaningful however for research/longitudinal study purposes, the data collected with the two systems cannot be used interchangeably.
非接触式角膜内皮显微镜及内皮分析的半自动方法在临床实践和研究中广泛应用。本研究评估了在正常角膜中使用不同半自动方法的两种非接触式角膜内皮显微镜之间检查者间的可重复性。
由两名检查者分别采用Topcon SP 2000P Image-NET回溯法和Konan CC7000中心法,对49名正常受试者独立计算平均细胞大小(ACS)、内皮细胞密度(ECD)、变异系数(CV)和六角形细胞比例值。通过95%一致性界限、组内相关系数(ICC)、Pearson相关系数和Spearman秩检验评估检查者间的可重复性以及仪器/方法之间的相关性。
检查者间在ACS和ECD测量方面的可重复性良好(ICC>0.85),但在CV和六角形细胞比例方面较弱(ICC<0.65)。两名检查者均发现,与Konan方法相比,Topcon方法测得的ACS显著更高,ECD显著更低(P<0.05)。检查者1测得的ACS和ECD平均差异分别为+26平方微米和-184个细胞/平方毫米,检查者2测得的分别为+36平方微米和-228个细胞/平方毫米。仪器/方法之间在CV或六角形细胞比例值方面未发现显著差异(P>0.05);然而,这些参数的相关性较低(r<0.20)。
两种仪器或方法均可在正常角膜上进行可重复且准确的ACS和ECD测量,但两种仪器之间的差异具有系统性且较为显著。不过,所发现的差异在临床上并无意义。然而,对于研究/纵向研究目的而言,用这两种系统收集的数据不能互换使用。