Quantification of Fluid Resolution and Visual Acuity Gain in Patients With Diabetic Macular Edema Using Deep Learning A Post Hoc Analysis of a Randomized Clinical Trial
Quantification of Fluid Resolution and Visual Acuity Gain in Patients With Diabetic Macular Edema Using Deep Learning A Post Hoc Analysis of a Randomized Clinical Trial
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DOI：
10.1001/jamaophthalmol.2020.2457
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发表时间：
2020-09-01
影响因子：
8.1
通讯作者：
Schmidt-Erfurth, Ursula M.
中科院分区：
文献类型：
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作者：
Roberts, Philipp K.;Vogl, Wolf-Dieter;Schmidt-Erfurth, Ursula M.
糖尿病性黄斑水肿（DME）已获得大量光学相干断层扫描（OCT）数据，但许多形态学特征尚未确定和量化。目的使用深度学习算法检查DME在抗血管内皮生长因子治疗期间视网膜内液（IRF）和视网膜下液（SRF）的体积变化。设计，设置，糖尿病视网膜病变临床研究网络（协议T）的随机临床试验的事后分析，评估了来自570名DME研究参与者的570只眼睛的6945次光谱域OCT体积扫描。原始试验于2012年8月21日至2018年10月18日进行。该分析于2017年12月7日至2020年1月15日进行。干预参与者根据预先定义的标准化方案接受阿柏西普，雷珠单抗，或贝伐单抗联合或不联合延迟激光。主要结果和测量IRF和SRF体积与最佳矫正视力（BCVA）治疗的相关性在12个月内使用深度学习算法。（男性302例[53%];白色369例[65%];平均[SD]年龄，43.4 [12.6]岁），中央3 mm的平均液体体积为448.6 nL基线时IRF为36.9 nL（95% CI，412.3-485.0 nL），SRF为36.9 nL（95% CI，27.0-46.7 nL），12个月时IRF为161.2 nL（95% CI，135.1-187.4 nL），SRF为4.4 nL（95% CI，1.7-7.1 nL）。基线时存在SRF与基线BCVA早期治疗糖尿病视网膜病变研究（ETDRS）评分（63.2）较差相关（95% CI，60.2-66.1）（近似Snellen等效值为20/63 [95% CI，20/50-20/63]），SRF患眼vs 66.9（95% CI，65.7-68.1）（近似Snellen当量，20/50 [95% CI，20/40-20/50]），无SRF（P < .001），ETDRS评分增加（0.5; 95% CI，0.3-0.8），基线时无SRF的患眼为0.4（95% CI，0.3-0.5）（P = 0.02），校正基线BCVA后。与贝伐珠单抗相比，阿柏西普在首次注射后（差异，79.8 nL; 95% CI，5.3-162.5 nL; P <0.001）和此后每4周（差异，10.4 nL; 95% CI，0.7-20.0 nL; P = 0.004）的IRF体积减少更大。与贝伐单抗相比，雷珠单抗与首次注射后IRF的更大降低相关（差异，75.2 nL; 95%CI，1.4-154.7 nL; P <0.001）。结论和相关性DME中液体的自动分割显示，SRF的存在与基线BCVA较低相关，但对抗血管内皮生长因子治疗有良好反应。这些自动频谱域OCT分析可在临床上用于评估治疗期间的解剖结构变化。
Importance Large amounts of optical coherence tomographic (OCT) data of diabetic macular edema (DME) are acquired, but many morphologic features have yet to be identified and quantified.Objective To examine the volumetric change of intraretinal fluid (IRF) and subretinal fluid (SRF) in DME during anti-vascular endothelial growth factor treatment using deep learning algorithms.Design, Setting, and Participants This post hoc analysis of a randomized clinical trial, the Diabetic Retinopathy Clinical Research Network (protocol T), assessed 6945 spectral-domain OCT volume scans of 570 eyes from 570 study participants with DME. The original trial was performed from August 21, 2012, to October 18, 2018. This analysis was performed from December 7, 2017, to January 15, 2020.Interventions Participants were treated according to a predefined, standardized protocol with aflibercept, ranibizumab, or bevacizumab with or without deferred laser.Main Outcomes and Measures The association of treatment with IRF and SRF volumes and best-corrected visual acuity (BCVA) during 12 months using deep learning algorithms.Results Among the 570 study participants (302 [53%] male; 369 [65%] white; mean [SD] age, 43.4 [12.6] years), the mean fluid volumes in the central 3 mm were 448.6 nL (95% CI, 412.3-485.0 nL) of IRF and 36.9 nL (95% CI, 27.0-46.7 nL) of SRF at baseline and 161.2 nL (95% CI, 135.1-187.4 nL) of IRF and 4.4 nL (95% CI, 1.7-7.1 nL) of SRF at 12 months. The presence of SRF at baseline was associated with a worse baseline BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) score of 63.2 (95% CI, 60.2-66.1) (approximate Snellen equivalent of 20/63 [95% CI, 20/50-20/63]) in eyes with SRF vs 66.9 (95% CI, 65.7-68.1) (approximate Snellen equivalent, 20/50 [95% CI, 20/40-20/50]) without SRF (P < .001) and a greater gain in ETDRS score (0.5; 95% CI, 0.3-0.8) every 4 weeks during follow-up in eyes with SRF at baseline vs 0.4 (95% CI, 0.3-0.5) in eyes without SRF at baseline (P = .02) when adjusted for baseline BCVA. Aflibercept was associated with greater reduction of IRF volume compared with bevacizumab after the first injection (difference, 79.8 nL; 95% CI, 5.3-162.5 nL; P < .001) and every 4 weeks thereafter (difference, 10.4 nL; 95% CI, 0.7-20.0 nL; P = .004). Ranibizumab was associated with a greater reduction of IRF after the first injection compared with bevacizumab (difference, 75.2 nL; 95% CI, 1.4-154.7 nL; P < .001).Conclusions and Relevance Automated segmentation of fluid in DME revealed that the presence of SRF was associated with lower baseline BCVA but with good response to anti-vascular endothelial growth factor therapy. These automated spectral-domain OCT analyses may be used clinically to assess anatomical change during therapy.