未经评估:要纵向评估NotalVisionHomeOCT(NVHO)的性能,包括用于患者在家自我成像的谱域OCT设备,用于自动数据上传的远程医疗基础设施,和用于自动OCT评估的深度学习算法。目的是研究该系统在日常图像采集和自动分析中的性能,并表征新生血管性年龄相关性黄斑变性(nAMD)中视网膜液渗出的动力学。
未经批准:试点,纵向观察研究。
未经批准:四个人(平均年龄,73.8年),在常规临床实践中接受抗血管内皮生长因子治疗的nAMD(一只或两只眼睛)。
UNASSIGNED:参与者每天在家中使用NVHO进行自我成像,为期1个月。黄斑立方体扫描自动上传到NotalHealthCloud。他们分别由NotalOCT分析仪(NOA)和人类专家分级人员评估是否存在液体,分割,和音量。
未经评估:每日自我成像完成,图像质量,采集时间,视网膜液自动分级和人工分级之间的协议,和流体体积的时间动力学。
未经评估:在发起的240次自我成像尝试中,成功完成的人数为211人(87.9%)。其中,97.6%质量满意。对于流体存在,在94.7%的病例中,NOA与人类分级一致。从24次流体扫描的子集中,对于NOA和人体液体体积测量之间的协议,相关系数为0.996,平均绝对差异为1.5nl(vs.0.995和1.2nl,分别,用于人类间协议)。流体体积的图形显示出流体渗出和治疗反应的动力学变化很大。
UNASSIGNED:参与者可以在家中进行日常自我成像,并生成质量令人满意的黄斑立方体扫描。自动定量OCT分析实现了与人类分级的高度一致。具有自动OCT分析的每日自我成像允许对流体渗出的动力学进行详细表征,并揭示眼睛之间的广泛变化。描述这些动态的度量可能成为重要的疾病生物标志物。家庭OCT远程医疗系统代表了疾病监测的替代范例;它们可以允许高度个性化的治疗决策,减少不必要的注射和诊所就诊。
UNASSIGNED: To evaluate longitudinally the performance of the Notal Vision Home OCT (NVHO), comprising a spectral-domain OCT device for patient self-imaging at home, telemedicine infrastructure for automated data upload, and deep learning algorithm for automated OCT evaluation. The aims were to study the system\'s performance in daily image acquisition and automated analysis and to characterize the dynamics of retinal fluid exudation in neovascular age-related macular degeneration (nAMD).
UNASSIGNED: Pilot prospective, observational longitudinal study.
UNASSIGNED: Four individuals (mean age, 73.8 years) with nAMD (one or both eyes) undergoing anti-vascular endothelial growth factor therapy in routine clinical practice.
UNASSIGNED: The participants performed daily self-imaging at home with the NVHO for 1 month. The macular cube scans were uploaded automatically to the Notal Health Cloud. They underwent evaluation separately by the Notal OCT Analyzer (NOA) and human expert graders for fluid presence, segmentation, and volume.
UNASSIGNED: Daily self-imaging completion, image quality, acquisition time, agreement between automated and human grading of retinal fluid, and temporal dynamics of fluid volume.
UNASSIGNED: Of 240 self-imaging attempts initiated, the number successfully completed was 211 (87.9%). Of these, 97.6% had satisfactory quality. For fluid presence, the NOA agreed with human grading in 94.7% of cases. From a subset of 24 scans with fluid, for agreement between NOA and human fluid volume measurements, the correlation coefficient was 0.996 and mean absolute difference was 1.5 nl (vs. 0.995 and 1.2 nl, respectively, for interhuman agreement). Graphic plots of fluid volume revealed wide variation in the dynamics of fluid exudation and treatment response.
UNASSIGNED: The participants could perform daily self-imaging at home and generate macular cube scans of satisfactory quality. Automated quantitative OCT analysis achieved high agreement with human grading. Daily self-imaging with automated OCT analysis permitted detailed characterization of the dynamics of fluid exudation and revealed wide variation between eyes. Metrics describing these dynamics may become important disease biomarkers. Home OCT telemedicine systems represent an alternative paradigm of disease monitoring; they may allow highly personalized retreatment decisions, with fewer unnecessary injections and clinic visits.