Lei Chak Seng, Yang Xinning, Ning Rui, Xiahou Jinxuan, Jiang Xinyu, Savini Giacomo, Schiano-Lomoriello Domenico, Zhou Xingtao, Li Kexin, Huang Jinhai
Eye Institute and Department of Ophthalmology, Eye and ENT Hospital, Fudan University, Shanghai, China.
NHC Key Laboratory of Myopia and Related Eye Diseases, Shanghai, China.
Ophthalmol Ther. 2025 May;14(5):1097-1109. doi: 10.1007/s40123-025-01120-3. Epub 2025 Mar 31.
This study aimed to evaluate the intraobserver repeatability and interobserver reproducibility of the LUS-1000 Plus, a new fully automatic optical low coherence reflectometry (OLCR)-based biometer, and its agreement with the IOLMaster 700, a swept-source optical coherence tomography (SS-OCT)-based biometer, for biometric measurement.
This prospective study included 77 right eyes from 77 healthy participants. The axial length (AL), central corneal thickness (CCT), aqueous depth (AQD), anterior chamber depth (ACD), flattest, steepest, mean keratometry (Kf, Ks, Km), astigmatism magnitude (AST), J, J vectors, and corneal diameter (CD) were measured. Repeatability and reproducibility were evaluated using the within-subject standard deviation (S), test-retest (TRT) repeatability, coefficient of variation (CoV), and intraclass correlation coefficient (ICC). To compare differences and establish agreement between the devices, paired t test and Bland-Altman plots were utilized. Double-angle plots were employed to analyze corneal astigmatism.
Repeatability and reproducibility analysis revealed low S, TRT, and CoV, accompanied by high ICC values for all evaluated parameters. The interdevice agreement was excellent, Bland-Altman plots showed narrow 95% limits of agreement (LoA) (AL - 0.05 to 0.04 mm, CCT - 22.03 to - 7.50 μm, AQD 0.01 to 0.14 mm, ACD 0.00 to 0.13 mm, LT - 0.16 to 0.02 mm, Kf - 0.24 to 0.23 D, Ks - 0.36 to 0.21 D, Km - 0.24 to 0.16 D, AST - 0.41 to 0.27 D, J - 0.15 to 0.17 D, J - 0.14 to 0.22 D, CD - 0.38 to 0.18 mm).
The LUS-1000 Plus demonstrated high repeatability and reproducibility, and excellent agreement with the IOLMaster 700, confirming its reliability and interchangeable use with the IOLMaster 700 in clinical practice.
本研究旨在评估新型全自动光学低相干反射仪（OLCR）LUS - 1000 Plus在生物测量方面的观察者内重复性和观察者间再现性，以及它与基于扫频光学相干断层扫描（SS - OCT）的生物测量仪IOLMaster 700的一致性。
这项前瞻性研究纳入了77名健康参与者的77只右眼。测量了眼轴长度（AL）、中央角膜厚度（CCT）、房水深度（AQD）、前房深度（ACD）、最平、最陡、平均角膜曲率（Kf、Ks、Km）、散光量（AST）、J、J向量和角膜直径（CD）。使用受试者内标准差（S）、重测（TRT）重复性、变异系数（CoV）和组内相关系数（ICC）评估重复性和再现性。为了比较差异并确定设备之间的一致性，采用配对t检验和Bland - Altman图。使用双角图分析角膜散光。
重复性和再现性分析显示，所有评估参数的S、TRT和CoV值较低，ICC值较高。设备间一致性极佳，Bland - Altman图显示一致性界限（LoA）较窄（AL为 - 0.05至0.04mm，CCT为 - 22.03至 - 7.50μm，AQD为0.01至0.14mm，ACD为0.00至0.13mm，LT为 - 0.16至0.02mm，Kf为 - 0.24至0.23D，Ks为 - 0.36至0.21D，Km为 - 0.24至0.16D，AST为 - 0.41至0.27D，J为 - 0.15至0.17D，J为 - 0.14至0.22D，CD为 - 0.38至0.18mm）。
LUS - 1000 Plus表现出高重复性和再现性，并且与IOLMaster 700一致性极佳，证实了其在临床实践中的可靠性以及可与IOLMaster 700互换使用。
