School of Ophthalmology and Optometry, Eye Hospitaland, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, Zhejiang, 325027, China.
National Clinical Research Center for Ocular Diseases, Wenzhou, Zhejiang, China.
BMC Ophthalmol. 2024 Oct 7;24(1):439. doi: 10.1186/s12886-024-03696-z.
To evaluate the repeatability and agreement of two swept-source optical coherence tomographers and Scheimpflug imaging for corneal curvature in healthy subjects to obtain data on the clinical application of a new device.
This prospective study was conducted in January and February 2021 with 100 healthy subjects at the Eye Hospital of Wenzhou Medical University. Simulated keratometry (Sim-K), posterior keratometry (Kp), total corneal power (TCP), and total corneal astigmatism (TCA) were measured with CASIA2, Anterion, and Pentacam. Within-subject standard deviation (Sw), repeatability coefficient (RC), coefficient of variation (CoV), and intraclass correlation coefficient (ICC) were used to assess inter-device repeatability. Bland-Altman analysis was performed to determine inter-device agreement.
The three devices showed good repeatability for Sim-K, Kp, and TCP with all ICC > 0.980. Pentacam showed the highest repeatability (ICC ≥ 0.993; ICC ≥ 0.993) while the CASIA2 demonstrated the lowest repeatability (ICC: ≥ 0.986; ICC: ≥ 0.985) for Sim-K and TCP. Anterion and CASIA2 revealed better repeatability (ICC ≥ 0.998; ICC ≥ 0.981) for Kp than Pentacam (ICC ≥ 0.980). Pentacam and Anterion showed good repeatability for TCA (ICC: 0.935 and 0.916), whereas the CASIA2 showed moderate repeatability (ICC: 0.836). Three instruments demonstrated good agreement with the maximum absolute 95% Limits of agreement (LoA) of 1.00 D for Sim-K, Kp, and TCP. Wide LoA were found for TCA with the maximum absolute 95% LoA ≥ 0.66 D between the three devices.
In healthy subjects, the three devices (Pentacam, Anterion and CASIA2) displayed comparable repeatability and accuracy for SimK, Kp, and TCP, and could be used interchangeably for these parameters. However, TCA measured by the three devices was not interchangeable.
Chinese Clinical Trial Registry Center (10/10/2020, ChiCTR2000038959).
评估两种扫频源光学相干断层扫描仪和 Scheimpflug 成像在健康受试者中测量角膜曲率的重复性和一致性,以获得一种新设备的临床应用数据。
本前瞻性研究于 2021 年 1 月和 2 月在温州医科大学眼视光医院进行,纳入 100 名健康受试者。使用 CASIA2、Anterion 和 Pentacam 测量模拟角膜曲率(Sim-K)、后角膜曲率(Kp)、总角膜屈光力(TCP)和总角膜散光(TCA)。采用组内标准差(Sw)、重复性系数(RC)、变异系数(CoV)和组内相关系数(ICC)评估设备间重复性。采用 Bland-Altman 分析评估设备间一致性。
三种设备对 Sim-K、Kp 和 TCP 的重复性均较好,所有 ICC 值均>0.980。Pentacam 的重复性最高(ICC≥0.993;ICC≥0.993),而 CASIA2 的重复性最低(ICC:≥0.986;ICC:≥0.985)。Anterion 和 CASIA2 对 Kp 的重复性优于 Pentacam(ICC≥0.998;ICC≥0.981)。Pentacam 和 Anterion 对 TCA 具有较好的重复性(ICC:0.935 和 0.916),而 CASIA2 为中度重复性(ICC:0.836)。三种仪器在 Sim-K、Kp 和 TCP 方面具有良好的一致性,最大绝对 95%界限(LoA)为 1.00 D。TCA 的 LoA 较宽,三种设备之间的最大绝对 95%LoA≥0.66 D。
在健康受试者中,三种设备(Pentacam、Anterion 和 CASIA2)在 SimK、Kp 和 TCP 方面具有相当的重复性和准确性,可互换用于这些参数。然而,三种设备测量的 TCA 不可互换。
中国临床试验注册中心(2020 年 10 月 10 日,ChiCTR2000038959)。