AIBILI - Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
CORC - Coimbra Ophthalmology Reading Centre, Coimbra, Portugal.
BMC Ophthalmol. 2024 Sep 3;24(1):387. doi: 10.1186/s12886-024-03537-z.
To analyse and compare the grading of diabetic retinopathy (DR) severity level using standard 35° ETDRS 7-fields photography and CLARUS™ 500 ultra-widefield imaging system.
A cross-sectional analysis of retinal images of patients with type 2 diabetes (n = 160 eyes) was performed for this study. All patients underwent 7-fields colour fundus photography (CFP) at 35° on a standard Topcon TRC-50DX camera, and ultra-widefield (UWF) imaging at 200° on a CLARUS™ 500 (ZEISS, Dublin, CA, USA) by an automatic montage of two 133° images (nasal and temporal). 35° 7-fields photographs were graded by two graders, according to the Early Treatment Diabetic Retinopathy Study (ETDRS). For CLARUS UWF images, a prototype 7-fields grid was applied using the CLARUS review software, and the same ETDRS grading procedures were performed inside that area only. Grading of DR severity level was compared between these two methods to evaluate the agreement between both imaging techniques.
Images of 160 eyes from 83 diabetic patients were considered for analysis. According to the 35° ETDRS 7-fields images, 22 eyes were evaluated as DR severity level 10-20, 64 eyes were evaluated as DR level 35, 41 eyes level 43, 21 eyes level 47, 7 eyes level 53, and 5 eyes level 61. The same DR severity level was achieved with CLARUS 500 UWF images in 92 eyes (57%), showing a perfect agreement (k > 0.80) with the 7-fields 35° technique. Fifty-seven eyes (36%) showed a higher DR level with CLARUS UWF images, mostly due to a better visualization of haemorrhages and a higher detection rate of intraretinal microvascular abnormalities (IRMA). Only 11 eyes (7%) showed a lower severity level with the CLARUS UWF system, due to the presence of artifacts or media opacities that precluded the correct evaluation of DR lesions.
UWF CLARUS 500 device showed nearly perfect agreement with standard 35° 7-fields images in all ETDRS severity levels. Moreover, CLARUS images showed an increased ability to detect haemorrhages and IRMA helping with finer evaluation of lesions, thus demonstrating that a UWF photograph can be used to grade ETDRS severity level with a better visualization than the standard 7-fields images.
Approved by the AIBILI - Association for Innovation and Biomedical Research on Light and Image Ethics Committee for Health with number CEC/009/17- EYEMARKER.
分析和比较使用标准 35° ETDRS 7 字段摄影和 CLARUS™ 500 超广角成像系统评估糖尿病视网膜病变（DR）严重程度分级的效果。
本研究对 160 只眼的 2 型糖尿病患者的视网膜图像进行了横断面分析。所有患者均在标准 Topcon TRC-50DX 相机上进行 35°彩色眼底照相（CFP），并在 CLARUS™ 500（ZEISS，Dublin，CA，USA）上使用两个 133°图像（鼻侧和颞侧）的自动拼接进行超广角（UWF）成像。根据早期糖尿病视网膜病变研究（ETDRS），由两位分级员对 35° 7 字段照片进行分级。对于 CLARUS UWF 图像，使用 CLARUS 审查软件应用了原型 7 字段网格，并在该区域内仅执行相同的 ETDRS 分级程序。比较这两种方法评估的 DR 严重程度分级，以评估两种成像技术之间的一致性。
对 83 例糖尿病患者的 160 只眼的图像进行了分析。根据 35° ETDRS 7 字段图像，22 只眼评估为 DR 严重程度 10-20，64 只眼评估为 DR 水平 35，41 只眼为 43 级，21 只眼为 47 级，7 只眼为 53 级，5 只眼为 61 级。使用 CLARUS 500 UWF 图像获得了 92 只眼（57%）相同的 DR 严重程度分级，与 7 字段 35°技术具有极好的一致性（k>0.80）。57 只眼（36%）用 CLARUS UWF 图像显示出更高的 DR 水平，这主要是由于更好地可视化了出血，并提高了视网膜内微血管异常（IRMA）的检测率。只有 11 只眼（7%）用 CLARUS UWF 系统显示出较低的严重程度分级，这是由于存在妨碍正确评估 DR 病变的伪影或介质混浊。
UWF CLARUS 500 设备在所有 ETDRS 严重程度分级中与标准的 35° 7 字段图像具有几乎完美的一致性。此外，CLARUS 图像显示出检测出血和 IRMA 的能力增强，有助于更精细地评估病变，从而证明超广角照片可用于分级 ETDRS 严重程度，其可视化效果优于标准的 7 字段图像。
获得 AIBILI-创新和光与图像伦理委员会用于健康的生物医学研究协会的批准，注册号为 CEC/009/17-EYEMARKER。
