Sydney Retina, Level 13, Park House, 187 Macquarie Street, Sydney, NSW, 2000, Australia.
Graduate School of Health, University of Technology, Sydney, New South Wales, Australia.
Graefes Arch Clin Exp Ophthalmol. 2021 Jul;259(7):1791-1802. doi: 10.1007/s00417-020-05050-7. Epub 2021 Jan 6.
To investigate the reliability and comparability of retinal measurements obtained with spectral-domain optical coherence tomography (OCT), optical coherence tomography angiography (OCTA), confocal scanning laser ophthalmoscopy (cSLO) colour images, and fundus autofluorescence (FAF) between two multimodal imaging platforms in eyes with macular pathology and normal, healthy volunteers.
This cross-sectional, multi-centre, instrument validation study recruited 94 consecutive subjects. All participants underwent a dilated examination and were scanned consecutively on the Heidelberg Spectralis (Heidelberg Engineering, Heidelberg, Germany) and Nidek Mirante (Nidek Co. Ltd., Gamagori, Japan) devices. Agreement between device images were evaluated from measures of the central retinal thickness (CRT), presence of segmentation and fixation imaging artefacts (IA), foveal avascular zone (FAZ) measurements; as well as sensitivity and specificity values from the detection of atrophy on fundus autofluorescence (FAF), drusen, subretinal drusenoid deposits, geographic atrophy, epiretinal membrane, fibrosis and haemorrhage on multicolour imaging, and agreement between devices and groups.
Compared with reference clinical examination, sensitivity values for the identification of retinal features using sole device images ranged from 100% for epiretinal membranes to 66.7% for subretinal drusenoid deposits (SSD). Mean absolute difference for CRT between OCT devices was 3.78 μm (95% confidence interval [CI]: - 21.39 to 28.95, P = 0.809). Differences in the superficial and deep capillary plexus FAZ area on OCTA between devices were not statistically significant (P = 0.881 and P = 0.595, respectively). IAs were significantly increased in the presence of macular pathology.
Comparison of retinal measurements between the OCT devices did not differ significantly. Common ultrastructural biomarkers of multiple macular pathologies were identified with high sensitivities and specificities, with good agreement between graders, indicating that they can be identified with comparable confidence in retinal imaging between the two devices.
研究两种多模态成像平台在黄斑病变和正常健康志愿者眼中获得的谱域光相干断层扫描（OCT）、光相干断层扫描血管造影（OCTA）、共焦扫描激光检眼镜（cSLO）彩色图像和眼底自发荧光（FAF）的视网膜测量值的可靠性和可比性。
这项横断面、多中心仪器验证研究招募了 94 名连续受试者。所有参与者均接受散瞳检查，并连续在海德堡 Spectralis（德国海德堡工程公司）和尼德克 Mirante（尼德克有限公司，日本滨松市）设备上进行扫描。通过评估中央视网膜厚度（CRT）、分割和固定成像伪影（IA）、中心凹无血管区（FAZ）测量值的测量值，以及眼底自发荧光（FAF）、玻璃膜疣、视网膜下类脂质沉积、地图状萎缩、脉络膜视网膜前膜、纤维化和出血的检测的敏感性和特异性值，评估设备之间的图像一致性，以及设备和组之间的一致性。
与参考临床检查相比，仅使用单一设备图像识别视网膜特征的敏感性值从 100%（用于治疗视网膜前膜）到 66.7%（用于治疗视网膜下类脂质沉积）。OCT 设备之间 CRT 的平均绝对差异为 3.78 μm（95%置信区间[CI]：-21.39 至 28.95，P=0.809）。设备之间 OCTA 浅层和深层毛细血管丛 FAZ 区域的差异无统计学意义（P=0.881 和 P=0.595）。存在黄斑病变时，IA 显著增加。
OCT 设备之间的视网膜测量值比较没有显著差异。多种黄斑病变的常见超微结构生物标志物具有较高的敏感性和特异性，分级之间具有良好的一致性，表明在两种设备之间的视网膜成像中，可以具有相当的信心来识别它们。
