Ophthalmology Science (Jun 2021)
Prospective, Longitudinal Pilot Study
Abstract
Purpose: 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). Design: Pilot prospective, observational longitudinal study. Participants: Four individuals (mean age, 73.8 years) with nAMD (one or both eyes) undergoing anti–vascular endothelial growth factor therapy in routine clinical practice. Methods: 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. Main Outcome Measures: Daily self-imaging completion, image quality, acquisition time, agreement between automated and human grading of retinal fluid, and temporal dynamics of fluid volume. Results: 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. Conclusions: 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.
