Notal Vision initiates study investigating at-home OCT monitoring of AMD
Notal Vision has initiated a longitudinal study to evaluate the ability of patients with wet age-related macular degeneration to perform daily self-imaging of their eyes using the Notal Home OCT device, according to a press release.
The investigational home-based OCT platform is designed to support patient management of wet AMD through patient-initiated retinal OCT scans, the release said.
“Remote OCT monitoring of wet AMD patients has the potential to personalize anti-VEGF treatment and improve outcomes while minimizing treatment burden by reducing the number of office visits,” Jeffrey S. Heier, MD, one of the study’s principal investigators and co-president and medical director of Ophthalmic Consultants of Boston, said in the release.
The study will remotely monitor 15 patients with wet AMD who are receiving standard of care anti-VEGF therapy for 90 days to track the presence of retinal fluid. Data will be automatically transmitted, and then the AI-based Notal OCT Analyzer will analyze and quantify intraretinal and subretinal fluid, the release said.
Data from a previous clinic-based trial showed image quality is sufficient for human graders to identify fluid in one of three consecutive tests, with a sensitivity of 97% and a specificity of 95%.
The technology received breakthrough device designation from the FDA in 2018, and the FDA clearance process is ongoing.