一种新型频域光学相干断层扫描生物测量仪的可重复性和再现性及其与基于扫频光学相干断层扫描的生物测量仪的一致性

Repeatability and reproducibility of a new spectral-domain optical coherence tomography biometer and agreement with swept-source optical coherence tomography based biometer.

作者信息

Li Xin, Lei Chak Seng, Ning Rui, Liu Luze, Chen Aodong, Yang Xinning, Savini Giacomo, Schiano-Lomoriello Domenico, Zhou Xingtao, Huang Jinhai

机构信息

Eye Institute and Department of Ophthalmology and Vision Science, Eye & ENT Hospital, Fudan University, Shanghai, 200031, China.

NHC Key Laboratory of Myopia and Related Eye Diseases, Key Laboratory of Myopia and Related Eye Diseases, Chinese Academy of Medical Sciences, Shanghai, 200031, China.

出版信息

Eye Vis (Lond). 2025 Feb 1;12(1):6. doi: 10.1186/s40662-024-00422-0.

DOI:10.1186/s40662-024-00422-0

PMID:39891211

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11786401/

Abstract

BACKGROUND

To assess the repeatability and reproducibility of the Colombo IOL biometer (Moptim, China), which utilizes spectral-domain optical coherence tomography (SD-OCT), in measuring ocular parameters of normal subjects and to compare its agreement with the swept-source optical coherence tomography (SS-OCT)-based IOLMaster 700 biometer (Carl Zeiss Meditec AG, Germany).

METHODS

This prospective study included 91 eyes from 91 normal subjects. The evaluated parameters were axial length (AL), central corneal thickness (CCT), aqueous depth (AQD), anterior chamber depth (ACD), lens thickness (LT), flattest and steepest meridian keratometry (Kf and Ks), mean keratometry (Km), astigmatism (AST) magnitude, white-to-white (WTW) distance, and pupil diameter (PD). The within-subject standard deviation (S), test-retest repeatability (TRT), coefficient of variation (CoV), and intraclass correlation coefficient (ICC) were calculated to determine the repeatability and reproducibility. Paired t-tests and Bland-Altman plots with 95% limits of agreement (LoA) were employed to assess the agreement.

RESULTS

With respect to intraobserver repeatability, the S and TRT values of all evaluated parameters were low. Except J and PD, the ICCs were all higher than 0.928. The reproducibility S and TRT values of Colombo IOL were also low, and ICCs were not lower than 0.900. Comparing Colombo IOL and IOLMaster 700, the 95% LoA of AL, CCT, AQD, ACD, LT, Kf, Ks, Km, AST, J, J, WTW and PD ranged from - 0.08 to 0.03 mm, - 21.58 to 5.09 μm, 0.01 to 0.15 mm, - 0.01 to 0.14 mm, - 0.05 to 0.10 mm, - 0.14 to 0.59 D, - 0.31 to 0.40 D, - 0.13 to 0.40 D, - 0.68 to 0.32 D, - 0.09 to 0.34 D, - 0.07 to 0.25 D, 0.11 to 1.47 mm, and - 0.97 to 2.31 mm, respectively.

CONCLUSION

The new SD-OCT-based Colombo IOL biometer demonstrates excellent repeatability and reproducibility. Moreover, it generally agrees well with the SS-OCT-based IOLMaster 700, except for the WTW and PD measurements.

摘要

背景

评估采用谱域光学相干断层扫描（SD - OCT）技术的科伦坡人工晶状体生物测量仪（中国迈普泰）在测量正常受试者眼部参数时的重复性和再现性，并将其与基于扫频光学相干断层扫描（SS - OCT）的IOLMaster 700生物测量仪（德国卡尔蔡司医疗技术股份公司）进行一致性比较。

方法

这项前瞻性研究纳入了91名正常受试者的91只眼。评估参数包括眼轴长度（AL）、中央角膜厚度（CCT）、房水深度（AQD）、前房深度（ACD）、晶状体厚度（LT）、最平及最陡子午线角膜曲率（Kf和Ks）、平均角膜曲率（Km）、散光（AST）度数、白对白（WTW）距离和瞳孔直径（PD）。计算受试者内标准差（S）、重测重复性（TRT）、变异系数（CoV）和组内相关系数（ICC）以确定重复性和再现性。采用配对t检验和具有95%一致性界限（LoA）的Bland - Altman图评估一致性。

结果

关于观察者内重复性，所有评估参数的S和TRT值均较低。除J和PD外，ICC均高于0.928。科伦坡人工晶状体生物测量仪的再现性S和TRT值也较低，ICC不低于0.900。比较科伦坡人工晶状体生物测量仪和IOLMaster 700，AL、CCT、AQD、ACD、LT、Kf、Ks、Km、AST、J、WTW和PD的95% LoA分别为 - 0.08至0.03 mm、 - 21.58至5.09 μm、0.01至0.15 mm、 - 0.01至0.14 mm、 - 0.05至0.10 mm、 - 0.14至0.59 D、 - 0.31至0.40 D、 - 0.13至0.40 D、 - 0.68至0.32 D、 - 0.09至0.34 D、 - 0.07至0.25 D、0.11至1.47 mm和 - 0.97至2.31 mm。