Casey Eye Institute, Oregon Health & Science University, Portland.
Department of Biomedical Engineering, Oregon Health & Science University, Portland.
JAMA Ophthalmol. 2021 Jul 1;139(7):734-741. doi: 10.1001/jamaophthalmol.2021.1275.
Diabetic macular edema (DME) is the predominant cause of visual impairment in patients with type 1 or 2 diabetes. Automated fluid volume measurements using optical coherence tomography (OCT) may improve the diagnostic accuracy of DME screening.
To assess the diagnostic accuracy of an automated central macular fluid volume (CMFV) quantification using OCT for DME.
DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional observational study was conducted at a tertiary academic center among 215 patients with diabetes (1 eye each) enrolled from January 26, 2015, to December 23, 2019. All participants underwent comprehensive examinations, 6 × 6-mm macular structural OCT horizontal raster scans, and 6 × 6-mm macular OCT angiography volumetric scans. From January 1 to March 30, 2020, 2 retinal specialists reviewed the structural OCT scans independently and diagnosed DME if intraretinal or subretinal fluid was present. Diabetic macular edema was considered center involved if fluid was present within the central fovea (central 1-mm circle). A third retinal specialist arbitrated any discrepancy. The mean central subfield thickness (CST) within the central fovea was measured on structural OCT horizontal raster scans. A deep learning algorithm automatically quantified fluid volumes on 6 × 6-mm OCT angiography volumetric scans and within the central foveas (CMFV).
The area under the receiver operating characteristic curve (AUROC) and the sensitivity and specificity of CST and CMFV for DME diagnosis.
We enrolled 1 eye each of 215 patients with diabetes (117 women [54.4%]; mean [SD] age, 59.6 [12.4] years). Diabetic macular edema was present in 136 eyes; 93 cases of DME were center involved. The AUROC of CMFV for diagnosis of center-involved DME (0.907 [95% CI, 0.861-0.954]) was greater than the AUROC of CST (0.832 [95% CI, 0.775-0.889]; P = .02). With the specificity set at 95%, the sensitivity of CMFV for detection of center-involved DME (78.5% [95% CI, 68.8%-86.3%]) was higher than that of CST (53.8% [95% CI, 43.1%-64.2%]; P = .002). Center-involved DME cases not detected by CST but detected by CMFV were associated with a thinner CST (290.8 μm [95% CI, 282.3-299.3 μm] vs 369.4 μm [95% CI, 347.1-391.7 μm]; P < .001), higher proportion of previous macular laser treatment (11 of 28 [39.3%; 95% CI, 21.5%-59.4%] vs 12 of 65 [18.5%; 95% CI, 9.9%-30.0%]; P = .03), and female sex (20 of 28 [71.4%; 95% CI, 51.3%-86.8%] vs 31 of 65 [47.7%; 95% CI, 35.1%-60.5%]; P = .04).
These findings suggest that an automated CMFV is a more accurate diagnostic biomarker than CST for DME and may improve screening for DME.
重要性:糖尿病性黄斑水肿(DME)是 1 型或 2 型糖尿病患者视力损害的主要原因。使用光学相干断层扫描(OCT)进行自动液体容积测量可能会提高 DME 筛查的诊断准确性。
目的:评估使用 OCT 对 DME 进行自动中央黄斑液体积(CMFV)定量的诊断准确性。
设计、地点和参与者:这是一项在一个三级学术中心进行的横断面观察性研究,共纳入 2015 年 1 月 26 日至 2019 年 12 月 23 日期间的 215 例糖尿病患者(每只眼 1 只)。所有参与者均接受了全面检查、6×6mm 黄斑结构 OCT 水平光栅扫描和 6×6mm 黄斑 OCT 血管造影容积扫描。2020 年 1 月 1 日至 3 月 30 日期间,2 位视网膜专家独立回顾了结构 OCT 扫描,并在存在视网膜内或视网膜下液体时诊断为 DME。如果液体位于中央凹(中央 1mm 圆内),则认为 DME 累及中心。任何差异均由第三位视网膜专家仲裁。在结构 OCT 水平光栅扫描上测量中央凹内的平均中央视场厚度(CST)。深度学习算法自动对 6×6mm OCT 血管造影容积扫描和中央凹内的液体体积进行量化(CMFV)。
主要结果和措施:DME 诊断中 CST 和 CMFV 的受试者工作特征曲线(AUROC)下面积(AUROC)以及敏感性和特异性。
结果:我们纳入了 215 例糖尿病患者(117 名女性[54.4%];平均[标准差]年龄 59.6[12.4]岁)的每只眼各 1 只。136 只眼中存在 DME;93 例 DME 累及中心。CMFV 对中心性 DME(0.907 [95%CI,0.861-0.954])的诊断 AUROC 大于 CST(0.832 [95%CI,0.775-0.889];P=0.02)。当特异性设定为 95%时,CMFV 检测中心性 DME 的敏感性(78.5% [95%CI,68.8%-86.3%])高于 CST(53.8% [95%CI,43.1%-64.2%];P=0.002)。CST 未检测到但 CMFV 检测到的中心性 DME 病例与 CST 更薄相关(290.8μm [95%CI,282.3-299.3μm]与 369.4μm [95%CI,347.1-391.7μm];P<0.001)、先前黄斑激光治疗的比例更高(28 例中有 11 例[39.3%;95%CI,21.5%-59.4%]与 65 例中有 12 例[18.5%;95%CI,9.9%-30.0%];P=0.03)和女性(28 例中有 20 例[71.4%;95%CI,51.3%-86.8%]与 65 例中有 31 例[47.7%;95%CI,35.1%-60.5%];P=0.04)。
结论和相关性:这些发现表明,自动 CMFV 是一种比 CST 更准确的 DME 诊断生物标志物,可能会提高 DME 的筛查效果。