Hanumunthadu Daren, Keane Pearse A, Balaskas Konstantinos, Dubis Adam M, Kalitzeos Angelos, Michaelides Michel, Patel Praveen J
NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, Institute of Ophthalmology, University College London, 162 City Road, London, EC1V 2PD, UK.
Ophthalmol Ther. 2021 Dec;10(4):913-922. doi: 10.1007/s40123-021-00377-8. Epub 2021 Jul 29.
To assess inter-device agreement in optical coherence tomography-derived retinal thickness measurements in patients with known macular conditions between spectral-domain and swept-source optical coherence tomography (OCT).
Two hundred seventy-two subjects were included in the study. They consisted of 91 male (33.5%) and 181 female (66.5%) subjects, and 132 left (48.5%) and 140 right (51.5%) eyes. Each subject underwent spectral-domain OCT (SD-OCT, Spectralis, Heidelberg Engineering; RTVue XR Avanti XR HD, Optovue) and swept-source OCT (SS-OCT; DRI-OCT-1, Atlantis, Topcon) in a single imaging session performed by the same clinical trial-certified technician. The comparison of retinal thickness reproducibility between devices was performed using Bland-Altman analyses and across the entire data set using the intraclass correlation coefficient (ICC).
The ICC of the retinal thickness measurements (95% confidence interval) made using all three OCT instruments was 0.81 (0.77-0.84). The mean difference in mean retinal thickness between Spectralis SD-OCT and Topcon SS-OCT was 59.1 μm (95% limit of agreement [LoA] -21.7 to 139.8 μm). The mean difference in mean retinal thickness between Optovue SD-OCT and Topcon SS-OCT was 21.8 μm (95% LoA -34.7 to 78.3 μm).
Retinal layer thickness measurements vary between SS-OCT and SD-OCT devices. We describe inter-device agreement in retinal thickness between SS-OCT and SD-OCT in patients with macular conditions. Clinicians should be aware of the differences in retinal thickness values when imaging patients using different OCT devices and should consider using the same OCT device model in order to monitor clinical change.
ClinicalTrials.gov Identifier (NCT02828215).
评估已知黄斑疾病患者在光谱域光学相干断层扫描（OCT）和扫频源光学相干断层扫描之间，光学相干断层扫描得出的视网膜厚度测量值的设备间一致性。
272名受试者纳入本研究。其中男性91名（33.5%），女性181名（66.5%）；左眼132只（48.5%），右眼140只（51.5%）。每位受试者在同一名经过临床试验认证的技术人员进行的单次成像检查中，接受了光谱域OCT（SD - OCT，Spectralis，海德堡工程公司；RTVue XR Avanti XR HD，Optovue）和扫频源OCT（SS - OCT；DRI - OCT - 1，Atlantis，拓普康）检查。使用Bland - Altman分析比较设备间视网膜厚度的可重复性，并使用组内相关系数（ICC）对整个数据集进行分析。
使用所有三种OCT仪器进行的视网膜厚度测量的ICC（95%置信区间）为0.81（0.77 - 0.84）。Spectralis SD - OCT与拓普康SS - OCT之间平均视网膜厚度的平均差异为59.1μm（95%一致性界限[LoA] - 21.7至139.μm）。Optovue SD - OCT与拓普康SS - OCT之间平均视网膜厚度的平均差异为21.8μm（95% LoA - 34.7至78.3μm）。
视网膜层厚度测量在SS - OCT和SD - OCT设备之间存在差异。我们描述了黄斑疾病患者中SS - OCT和SD - OCT之间视网膜厚度的设备间一致性。临床医生在使用不同OCT设备对患者进行成像时应意识到视网膜厚度值的差异，并应考虑使用相同的OCT设备型号以监测临床变化。
ClinicalTrials.gov标识符（NCT02828215）。
