Purpose To determine the diagnostic validity of quantitative measures derived from optical coherence tomography (OCT) images in their ability to discriminate between cohorts of eyes unaffected by hydroxychloroquine (HCQ) and those with a range of toxicity severities, including mild toxicity. Methods Prospective, single-centre, case–control study conducted between August 2010 and May 2017. Participants were exposed to HCQ for at least 5 years (mean±SD =14±7.2 years) and classified into affected and unaffected cohorts based on the American Academy of Ophthalmology’s 2016 recommendations. For affected eyes, severity (groups 1–4) was assigned based on the extent of ellipsoid zone loss. For all eyes, spectral domain-OCT scans were analysed quantitatively to compute inner retinal thickness (IRT), outer retinal thickness (ORT), and minimum signal intensity (MI) and compared across toxicity groups. Results Of the 85 participants (mean age 59±12 years, 93% female), 30 had retinal toxicity. Significant differences in ORT and MI were observed between each affected severity group and unaffected eyes. Significant differences in IRT were observed for groups 3–4 but not groups 1–2. ORT and MI were each able to discriminate between unaffected and group 1 eyes with the highest discrimination at the inner subfields (areas under the curve, AUC=0.96 for ORT and AUC=0.93 for MI). Conclusions Quantitative analysis of OCT scans revealed significant differences between eyes with and without toxicity in two different measures. Each individual metric could discriminate between the unaffected and the lowest severity category, suggesting their potential utility in screening for HCQ toxicity in patients at risk. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information. Deidentified participant data that support the findings of this study are available from the corresponding author, CC at cukrasc@nei.nih.gov, on reasonable request and abiding by institutional sharing guidelines.

中文翻译：

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不同严重程度羟氯喹中毒患者的光学相干断层成像定量分析

目的 确定源自光学相干断层扫描 (OCT) 图像的定量测量的诊断有效性，因为它们能够区分未受羟氯喹 (HCQ) 影响的眼睛队列和具有一系列毒性严重程度（包括轻度毒性）的眼睛队列。方法 2010 年 8 月至 2017 年 5 月进行的前瞻性、单中心、病例对照研究。参与者暴露于 HCQ 至少 5 年（平均±SD = 14±7.2 年），并根据美国人群分为受影响和未受影响的队列眼科学会 2016 年的建议。对于受影响的眼睛，严重程度（第 1-4 组）是根据椭圆体区域损失的程度来分​​配的。对于所有眼睛，定量分析光谱域 OCT 扫描以计算内视网膜厚度 (IRT)、外视网膜厚度 (ORT)、和最小信号强度 (MI)，并在不同毒性组之间进行比较。结果 在 85 名参与者（平均年龄 59±12 岁，93% 为女性）中，30 名有视网膜毒性。在每个受影响的严重程度组和未受影响的眼睛之间观察到 ORT 和 MI 的显着差异。对于第 3-4 组而非第 1-2 组观察到 IRT 的显着差异。ORT 和 MI 均能够区分未受影响的眼睛和第 1 组眼睛，在内部子区域（曲线下面积，ORT 的 AUC = 0.96，MI 的 AUC = 0.93）具有最高的辨别力。结论 OCT 扫描的定量分析显示，在两种不同的测量中，有毒性和无毒性的眼睛之间存在显着差异。每个单独的指标都可以区分未受影响和最低严重性类别，表明它们在筛查高危患者 HCQ 毒性方面的潜在效用。可应合理要求提供数据。与研究相关的所有数据都包含在文章中或作为在线补充信息上传。支持本研究结果的身份不明的参与者数据可从相应的作者 CC cukrasc@nei.nih.gov 获得，应合理要求并遵守机构共享指南。