Department of Ophthalmology, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy.
Invest Ophthalmol Vis Sci. 2012 Aug 31;53(9):5912-20. doi: 10.1167/iovs.11-8644.
The clinical utility of new optical coherence tomography (OCT) instruments strongly depends on measurements reproducibility. The aim of this study was to assess retinal nerve fiber layer (RNFL) thickness reproducibility using six different spectral-domain OCTs (SD-OCTs) and one time-domain OCT.
RNFL thickness (average and four quadrant) from six SD-OCTs (Spectral OCT/SLO OPKO/OTI, 3D-OCT 2000 Topcon, RS-3000 NIDEK, Cirrus HD-OCT Zeiss, RTVue-100 Optovue, and Spectralis Heidelberg) and one time-domain OCT (Stratus OCT Zeiss) was measured twice in 38 right eyes of 38 randomly chosen healthy volunteers by two masked operators. Inter- and intraoperator reproducibility was evaluated by the intraclass correlation coefficient (ICC), coefficient of variation (CV), and Bland-Altman test analysis. Instrument-to-instrument reproducibility was determined by ANOVA for repeated measures. We also tested how the devices disagree in terms of systemic bias and random error using a structural equation model.
Mean RNFL average thickness ranged from 90.08 μm to 106.51 μm. Cirrus and Heidelberg showed the thinnest RNFL values in all measurements, Topcon the highest. ICC, CV, and Bland-Altman plots showed variable inter- and intraoperator agreement depending on the instrument. Heidelberg demonstrated the best interoperator (ICC, 0.92; CV, 1.56%) and intraoperator (ICC, 0.94 and 0.95; CV, 1.28% and 1.26%, respectively, for operator A and operator B) agreement for average RNFL thickness.
Heidelberg demonstrated the higher agreement in inter- and intraoperator reproducibility, Optovue the worst. In light of our error analysis results, we found that a scale bias among instruments could interfere with a thorough RNFL monitoring, suggesting that best monitoring is obtained with the same operator and the same device.
新型光学相干断层扫描(OCT)仪器的临床实用性很大程度上取决于测量的可重复性。本研究旨在评估六种不同的谱域 OCT(SD-OCT)和一种时域 OCT 测量视网膜神经纤维层(RNFL)厚度的可重复性。
38 名随机选择的健康志愿者的 38 只右眼,由两名经过培训的操作人员分别使用 6 种 SD-OCT(Spectral OCT/SLO OPKO/OTI、3D-OCT 2000 Topcon、RS-3000 NIDEK、Cirrus HD-OCT Zeiss、RTVue-100 Optovue 和 Spectralis Heidelberg)和 1 种时域 OCT(Stratus OCT Zeiss)进行两次 RNFL 厚度(平均值和四个象限)测量。通过组内相关系数(ICC)、变异系数(CV)和 Bland-Altman 检验分析评估了操作者内和操作者间的可重复性。采用重复测量方差分析(ANOVA)评估仪器间的可重复性。我们还使用结构方程模型来评估设备之间在系统偏差和随机误差方面的差异。
平均 RNFL 平均厚度范围为 90.08 μm 至 106.51 μm。Cirrus 和 Heidelberg 显示在所有测量中 RNFL 值最薄,Topcon 显示的 RNFL 值最高。ICC、CV 和 Bland-Altman 图显示,不同的仪器具有不同的操作者内和操作者间的一致性。Heidelberg 在平均 RNFL 厚度方面表现出最佳的操作者间(ICC,0.92;CV,1.56%)和操作者内(ICC,0.94 和 0.95;CV,1.28% 和 1.26%,分别为操作者 A 和操作者 B)一致性。
Heidelberg 在操作者内和操作者间的可重复性方面表现出更高的一致性,Optovue 的表现最差。根据我们的误差分析结果,我们发现仪器之间的标度偏差可能会干扰对 RNFL 的全面监测,这表明最好的监测是由同一名操作者和同一台设备获得的。