Objectives To evaluate the feasibility and accuracy of a portable, self-imaging optical coherence tomography (OCT) for measuring central subfield thickness (CST) and achieving diagnostic concordance for retinal lesions compared with clinic-based spectral-domain OCT (SD-OCT). Methods This comparative, cross-sectional study was conducted between August 2020 and February 2021. Two groups of adult participants were recruited: (1) a selected cohort of 160 participants with confirmed diagnosis and (2) a consecutive cohort of 315 participants recruited randomly. All participants underwent self-imaging OCT examination, as well as standard OCT examination. CST was automatically calculated for comparisons between the two OCT devices. Diagnostic concordance for retinal lesions and the success rate of self-imaging were assessed within the consecutive cohort. Results In the selected cohort, self-imaging OCT images yielded consistent CST with SD-OCT, with a mean difference of 0.1±7.7 µm for normal eyes, 4.9±10.6 µm for macular oedema, −1.3±9.5 µm for choroidal neovascularisation, 5.0±7.8 µm for epiretinal membrane. The self-imaging OCT also demonstrated good repeatability, with a mean test–retest difference in CST of 0.7±3.9 µm and limits of agreement ranging from −6.9 to 8.3 µm. Additionally, within the consecutive cohort, interdevice κ values ranged for detecting various retinal lesions ranged from 0.8 to 1.0, except in the cases of retinal detachment (κ=0.5). All eyes (100%) in the selected cohort and 242 eyes (76.8%) in the consecutive cohort successfully completed self-imaging. Participants spent less time on self-imaging compared with SD-OCT operated by a technician (66.7±20.1 vs 73.3±32.5, p<0.01). A majority of participants (90%) found the self-imaging process ‘easy’ and ‘comfortable’. Conclusions and relevance This study demonstrates that our self-imaging OCT and clinical-used SD-OCT are highly consistent not only in measuring the CST but also in identifying most retinal lesions. Data are available on reasonable request. Data are available on reasonable request. Deidentified participant data can be requested from the co-corresponding authors.

中文翻译：

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自成像 OCT 用于视网膜疾病远程诊断和监测的评估


目的 评估便携式自成像光学相干断层扫描 (OCT) 测量中心子场厚度 (CST) 的可行性和准确性，并与临床谱域 OCT (SD-OCT) 相比实现视网膜病变诊断一致性。方法 这项比较横断面研究于 2020 年 8 月至 2021 年 2 月期间进行。招募了两组成年参与者：(1) 一组由 160 名确诊参与者组成的选定队列；(2) 一组随机招募的由 315 名参与者组成的连续队列。所有参与者均接受自我成像 OCT 检查以及标准 OCT 检查。自动计算 CST 以比较两个 OCT 设备。在连续队列中评估了视网膜病变的诊断一致性和自我成像的成功率。结果 在所选队列中，自我成像 OCT 图像产生与 SD-OCT 一致的 CST，正常眼平均差异为 0.1±7.7μm，黄斑水肿为 4.9±10.6μm，脉络膜新生血管为 -1.3±9.5μm，5.0对于视网膜前膜，±7.8 μm。自成像 OCT 也表现出良好的重复性，CST 的平均重测差异为 0.7±3.9μm，一致性范围为 -6.9 至 8.3μm。此外，在连续队列中，检测各种视网膜病变的设备间 κ 值范围为 0.8 至 1.0，但视网膜脱离的情况除外 (κ=0.5)。所选队列中的所有眼睛 (100%) 和连续队列中的 242 只眼睛 (76.8%) 成功完成自我成像。与技术人员操作的 SD-OCT 相比，参与者花在自我成像上的时间更少 (66.7±20.1 vs 73.3±32.5，p<0.01)。 大多数参与者（90%）认为自我想象的过程“简单”且“舒适”。结论和相关性 这项研究表明，我们的自成像 OCT 和临床使用的 SD-OCT 不仅在测量 CST 方面高度一致，而且在识别大多数视网膜病变方面也高度一致。可根据合理要求提供数据。可根据合理要求提供数据。可以向共同通讯作者索取去识别化的参与者数据。