First U.S. clinical trial initiated with patient-operated home OCT device for monitoring patients diagnosed with exudative age-related macular degeneration (eAMD)
Notal Vision, Inc., a privately-held ophthalmic diagnostic services company, focused on advancing eye care by extending ophthalmic disease management from the clinic to the home, has announced the achievement 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 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’s 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 light-weight, patient-operated (technician-free) OCT device easily utilized by elderly, visually-impaired patients with eAMD. The device will generate OCT images to be analyzed by a proprietary 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 in 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. Michael J. Elman, MD, Principal Investigator noted, “Early user experience results indicate that elderly patients with advanced AMD and reduced visual acuity can effectively self-operate the Notal Home OCT with minimal training. Patient feedback specific to device simplicity, usability, and ease of testing has been exceedingly positive.”
Images produced by the Notal Home OCT System were shared with leading retina specialists at the American Academy of Ophthalmology (AAO) 2018 meeting which recently took place in Chicago. 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.
“The initiation of our first U.S. based home OCT clinical trial is an important step towards bringing this leading-edge technology to eAMD patients, their caregivers, and the eye care community,” said Dr. Susan Orr, Chief Medical Officer at Notal Vision and incoming Chief Executive Officer. “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.”
“As a team, we are excited to be making an impact in addressing one of the most critical unmet needs in retina with the Home OCT device,” said Dr. David Creasey, Chief Executive Officer at Wasatch Photonics. Nishant Mohan, Vice President OCT Division added, “We believe the innovation that has led to development of self-operated OCT for in-home patient use marks a critical juncture for this modality. As home-based OCT realizes its scale, its use and the data generated from it will be transformative to the future of ophthalmic instrumentation.”
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. Notal Vision will expand its ongoing U.S. clinical trial program in 2019.