Home OCT study commences for tracking wet AMD
The first patients have been enrolled in Notal Vision’s home-based study with its investigational OCT remote monitoring device for tracking retinal fluid in patients with wet age-related macular degeneration.
The Home OCT program longitudinal study aims to investigate changes in retinal fluid in patients receiving anti-VEGF treatment using patient-initiated retinal OCT scans, a press release said.
In the study design, up to 15 patients recruited at Tel Aviv Medical Center and Assuta HaShalom in Tel Aviv, Israel, will perform daily scans of their eyes for 1 month. Scans are automatically uploaded to the Notal Health Cloud where they can be viewed remotely by study investigators.
The technology received breakthrough device designation from the FDA in 2018 and is under FDA review for clearance.
An earlier study demonstrated the device’s ability to track disease status and that the images provided were sufficient for a human investigator to identify fluid in one of three consecutive tests with a sensitivity of 97% and a specificity of 95%, according to the release.
“Home OCT will provide treating physicians with inter-visit disease knowledge and help us reduce the treatment and monitoring burden on patients and their caregivers,” principal investigator Anat Loewenstein, MD, said.