Performance data for NOTAL-OCT V3.0, a patient-operated home-based optical coherence tomography device, presented at international meeting in Miami
Longitudinal data on retinal imaging of age-related macular degeneration (AMD) patients using the final form factor of Notal Vision’s home OCT (NOTAL-OCT V3.0) was presented at the Angiogenesis, Exudation, and Degeneration meeting in Miami. The pipeline technology is designed to use home-based, patient-initiated retinal OCT scans to support the management of patients with exudative AMD, complementing existing standard of care as well as emerging longer acting drugs and drug delivery systems.
“This is the first time nano-liter scale quantities of intra- and subretinal fluid have been tracked over time based on home OCT images and deep learning retinal fluid analytics from patients receiving anti-VEGF therapy,” said Kester Nahen, PhD, CEO of Notal Vision. “The reports generated from the data allow physicians to analyze the temporal dynamics of a patient’s retinal fluid, including fluid volume and thickness maps.”
The NOTAL-OCT V3.0 trial is recruiting 200 AMD patients at two study sites in Tel Aviv, Israel. The results show that the areas of fluid seen on home OCT based intra- and subretinal fluid thickness maps correlate well with the locations of of abnormal vessels seen on OCT angiography as well as leakage areas on fluorescein angiography, demonstrating the technology’s ability to track disease status.
“Home OCT will allow physicians to better assess retreatment intervals and catch the appearance of retinal fluid as soon as it occurs, rather than at the patient’s next clinic visit, which may be far in the future” said Anat Loewenstein, MD, the study’s principal investigator and the Director of the Department of Ophthalmology at Tel Aviv Medical Center in Israel. “I foresee the gap in visual outcomes between randomized controlled trials and our real-world experience to shrink with the use of home OCT.”
Notal Vision’s home-based OCT pipeline technology received FDA Breakthrough Device designation at the end of 2018, and is in the process of obtaining FDA clearance. In January 2020 the American Medical Association established three category III Current Procedural Terminology (CPT®) codes for reporting patient-initiated remote retinal OCT scans, facilitated by Notal Vision’s home-based OCT. Home OCT has the potential to support current and future advances retinal disease management.
Source: Company Press Release