Yu Jinjin, Lin Xuanqiao, Huang Xiaomin, Xu Zhenyu, Ning Rui, Li Kexin, Savini Giacomo, Schiano-Lomoriello Domenico, Zhou Xingtao, Huang Jinhai
Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, N No. 19 Baoqing Road, Xuhui District, Shanghai, 200031, China.
Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China.
Eye Vis (Lond). 2024 Mar 4;11(1):9. doi: 10.1186/s40662-024-00377-2.
To evaluate the intraobserver repeatability and interobserver reproducibility of a newly developed dynamic real-time visualization 25 kHz swept-source optical coherence tomography (SS-OCT) based biometer (ZW-30, TowardPi Medical Technology Ltd, China) and compare its agreement with another SS-OCT based biometer (IOLMaster 700, Carl Zeiss Meditec AG, Jena, Germany).
Eighty-two healthy right eyes were enrolled in this prospective observational study. Measurements were repeated for three times using the ZW-30 and IOLMaster 700 in a random order. Obtained parameters included axial length (AL), central corneal thickness (CCT), aqueous depth (AQD), anterior chamber depth (ACD), lens thickness (LT), mean keratometry (Km), astigmatism magnitude (AST), vector J, vector J, and corneal diameter (CD). The within-subject standard deviation (Sw), test-retest (TRT) variability, coefficient of variation (CoV), and intraclass correlation coefficient (ICC) were adopted to assess the intraobserver repeatability and interobserver reproducibility. The double-angle plot was also used to display the distribution of AST. To estimate agreement, Bland-Altman plots were used.
For the intraobserver repeatability and interobserver reproducibility, the Sw, TRT and CoV for all parameters were low. Meanwhile, the ICC values were all close to 1.000, except for the J (ICC = 0.887 for the intraobserver repeatability). The double-angle plot showed that the distribution of AST measured by these two devices was similar. For agreement, the Bland-Altman plots showed narrow 95% limits of agreements (LoAs) for AL, CCT, AQD, ACD, LT, Km AST, J, J, and CD (- 0.02 mm to 0.02 mm, - 7.49 μm to 8.08 μm, - 0.07 mm to 0.04 mm, - 0.07 mm to 0.04 mm, - 0.07 mm to 0.08 mm, - 0.16 D to 0.30 D, - 0.30 D to 0.29 D, - 0.16 D to 0.16 D, - 0.23 D to 0.13 D, and - 0.39 mm to 0.10 mm, respectively).
The newly dynamic real-time visualization biometer exhibited excellent intraobserver repeatability and interobserver reproducibility. The two devices both based on the SS-OCT principle had similar ocular parameters measurement values and can be interchanged in clinical practice.
评估一种新开发的基于25kHz扫频源光学相干断层扫描(SS-OCT)的动态实时可视化生物测量仪(ZW-30,图湃医疗科技有限公司,中国)的观察者内重复性和观察者间再现性,并将其与另一种基于SS-OCT的生物测量仪(IOLMaster 700,卡尔蔡司医疗技术公司,耶拿,德国)进行一致性比较。
82只健康右眼纳入这项前瞻性观察研究。使用ZW-30和IOLMaster 700以随机顺序重复测量3次。获得的参数包括眼轴长度(AL)、中央角膜厚度(CCT)、房水深度(AQD)、前房深度(ACD)、晶状体厚度(LT)、平均角膜曲率(Km)、散光量(AST)、矢量J、矢量J和角膜直径(CD)。采用受试者内标准差(Sw)、重测(TRT)变异性、变异系数(CoV)和组内相关系数(ICC)来评估观察者内重复性和观察者间再现性。双角图也用于显示AST的分布。为估计一致性,使用Bland-Altman图。
对于观察者内重复性和观察者间再现性,所有参数的Sw、TRT和CoV均较低。同时,除J外(观察者内重复性的ICC = 0.887),ICC值均接近1.000。双角图显示这两种设备测量的AST分布相似。对于一致性,Bland-Altman图显示AL、CCT、AQD、ACD、LT、Km、AST、J、J和CD的95%一致性界限(LoA)较窄(分别为-0.02mm至0.02mm、-7.49μm至8.08μm、-0.07mm至0.04mm、-0.07mm至0.