Manassas, VA, March 08, 2022 (GLOBE NEWSWIRE) — Manassas, VA (March 8, 2022) — Digital healthcare provider Notal Vision announced today that results from the first U.S.-based study with its home-based experimental optical coherence tomography (OCT) have been published in Ophthalmology Retina1. Notal Home OCT pipeline technology is designed to provide patient-initiated retinal OCT scans to support the management of patients with Wet Age-Related Macular Degeneration (AMD), as an addition to existing standard of care treatments as well as emerging longer-acting drugs and drug delivery systems. .
Investigators from Ophthalmology Consultants of Boston and the Pepose Vision Institute of St. Louis report results comparing patient-operated at-home Notal OCT using the proprietary artificial intelligence (AI) Notal OCT Analyzer ( NOATM), with standard of care in-office OCT analyzed by retina specialists. Investigators found over 95% concordance when comparing the ability to detect retinal fluid, a primary marker for treatment orientation, between home notal OCT and office OCT.
The results are very significant for the management of patients with wet AMD, the leading cause of blindness in the United States. Several treatments for wet AMD have been developed over the past 2 decades. However, they require frequent patient visits to physicians for fluid status assessment, which places a huge burden on physicians, patients, and caregivers, which has limited the true effectiveness of these treatments.
“The insights into disease dynamics and treatment response gained from AI-based analysis of daily home OCT images provide new opportunities for personalized treatment and potentially better outcomes,” said Jeffrey. S. Heier, MD, one of the study’s principal investigators and director of the retina and retina research department at Ophthalmic Consultants of Boston. “Remote monitoring services can help retina specialists extend care to patients’ homes and provide timely treatment in the office when needed. »
The study assessed the ability of subjects with AMD to perform sequential daily self-imaging of their eyes for three months. The cohort included 15 patients and 29 eyes demonstrating a 95% success rate over approximately 2,500 scans performed. Each scan took less than 40 seconds per eye. Following home self-installation, subjects used the device an average of 5.7 days per week, and a median of one scan callback was provided by the engagement tracking service and patient compliance at the Notal Vision Monitoring Center, future medical supplier of the Notal Home OCT Programme. Additionally, patients responded positively 97% of times to the survey regarding the ease of use and convenience of daily imaging.
“The consistency in achieving high image quality was incredible given the patient’s self-use of the device,” said Nancy M. Holekamp, MD, co-principal investigator of the study and director of retina services at the Pepose Vision Institute. “The ease of use of home OCT stands out recognizing that trained personnel are usually required to acquire such images in an office environment.”
Built-in cellular connectivity enabled automatic transmission of Home OCT images to the secure cloud of digital healthcare providers for remote analysis and review by a physician. New fluid volume trajectories have provided insight into the heterogeneity of disease dynamics and treatment response. In some cases, pre-scheduled treatment and extension visits have exposed the retina to recurrent or persistent fluid for an extended period. These results confirmed the need for an alert mechanism based on eye-specific, physician-defined fluid volume thresholds, which is currently under development. Additionally, the parametric description of fluid volume trajectories that was reported in the study may support the classification of disease and treatment response.
“The excellent performance of our Home OCT platform in the first US study supports the goals set for the ongoing regulatory trials for FDA clearance,” said Kester Nahen, PhD, CEO of Notal Vision, Inc. “We would like to thank Genentech, a member of the Roche group, for their financial support of the study.
Notal Vision’s in-home OCT pipeline technology has received FDA Breakthrough Device designation 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 OCT. Physician review, interpretation and documentation of AI-based scans will be billable every 30 days.
- Liu Y., Holekamp NM and Heier JS, Prospective longitudinal study: daily self-imaging with OCT at home in neovascular age-related macular degeneration, Ophthalmology Retina (2022), doi: https://doi.org/10.1016 /d. oret.2022.02.011
About Notal Vision
Notal Vision is a remote monitoring services company that operates the Notal Vision Monitoring Center, a medical provider with a proven platform to engage patients and AI-based analytics of high-end personalized health data. volume that extend disease management from the clinic to the home to improve visual outcomes, reduce treatment burden and improve health economics. www.notalvision.com
The ForeseeHome® AMD Monitoring Program is a comprehensive platform, which includes an FDA-approved device that monitors visual changes in patients with intermediate dry AMD at risk of vision loss due to undiagnosed wet AMD . The clinical utility of ForeseeHome was established in the Home Monitoring of The Eye (HOME) study, part of the National Eye Institute-sponsored AREDS2 study, in which 94% of patients using ForeseeHome twice weekly who progressed to wet AMD, maintained 20/40 or better vision compared to only 62% of patients in a control group diagnosed during a routine eye exam or visit triggered by symptoms. Based on strong Level 1 evidence and compelling clinical results demonstrating the ability to detect choroidal neovascularization (CNV) earlier, ForeseeHome’s AMD monitoring program was granted Medicare coverage in 2016. Learn More , go to www.foreseehome.com.
Notal Vision’s Home OCT System will allow wet AMD patients to perform technician-less OCT testing at home with fast, self-guided fixation – critical components, especially for elderly patients frequently with pre-existing vision loss. The Notal OCT Analyzer (NOATM), a proprietary, in-house developed deep learning algorithm, performs automated analysis of home OCT scans and generates a report to the physician when a physician-specified change in activity disease is detected. The Notal Vision Diagnostic Clinic provides referring physicians with patient data via an online portal. Additionally, physicians will have 24/7 access to all B-scan images of their patients from each home OCT test with the location of fluid annotated on each B-scan. Following receipt by the physician of an alert report, patients may be brought to the office for evaluation and treatment at the discretion of the physician. NOA can also analyze the output of other commercial OCT devices, and data from published studies indicate that NOA’s performance in detecting disease activity was similar to that of retina doctors when each was compared to a panel of experts. Notal Vision’s home OCT has the potential to support current and future advances in the management of retinal disease.
Patient using OCT at home
Fluid volume graph