Ophthalmic diagnostic services companyNotal Vision (Manassas, VA) has achieved of a significant milestone in its plan to develop and commercialize a home-based, patient-operated, spectral-domain optical coherence tomography (SD-OCT) system. The first targeted application of the Notal Home OCT System is to monitor exudative (wet) age-related macular degeneration (eAMD) patients between scheduled, standard-of-care examinations by their treating retinal specialist.
Notal Vision has leveraged Wasatch Photonics' (Durham, NC) expertise in modular OCT system design to advance the development of their reliable, cost-optimized OCT engine, a key component of the Notal Home OCT System. The home diagnostic testing system will include a lightweight, patient-operated OCT device that is easy enough to use by elderly, visually impaired patients with eAMD. The device will generate OCT images to be analyzed by an artificial intelligence (AI) algorithm at the Notal Vision Diagnostic Clinic (NVDC). A patient's physician will have access to their daily tests as well as notification of changes in disease.
Following several clinical studies in Israel, the first U.S. study was initiated in October 2018 at Elman Retina Group (Baltimore, MD). The trial is enrolling eAMD patients with visual acuity as low as 20/400 to evaluate the performance and patient experience self-operating the device.
Images produced by the Notal Home OCT System were shared with leading retina specialists at the American Academy of Ophthalmology (AAO) 2018 meeting, which took place October 27-30 in Chicago, IL. The images were deemed to be of excellent quality, allowing clear identification of retinal pathology and in concordance with commercial OCT imaging performed in parallel.
"Our collaboration with Wasatch Photonics will continue to be instrumental to our organization, as the U.S. Food and Drug Administration (FDA) recently granted our Home Optical Coherence Tomography (OCT) System with Breakthrough Device Designation, a program designed to expedite patient access to novel technologies," says Susan Orr, chief medical officer at Notal Vision and incoming chief executive officer.
The Notal Home OCT System is intended for testing at home between regularly scheduled clinic assessments and not intended to replace standard-of-care examinations or clinical testing by a retinal specialist. The company will expand its ongoing U.S. clinical trial program in 2019.