Manassas, VA, April 26, 2022 (GLOBE NEWSWIRE) -- Notal Vision, Inc. reported today the publication of the Analysis of Long-term visual Outcomes of ForeseeHome Remote Telemonitoring (ALOFT) study results in Ophthalmology Retina. The study showed remarkable long-term visual outcomes for patients participating in the Medicare covered, AI-enabled ForeseeHome AMD Monitoring Program, provided by the Notal Vision Monitoring Center.
The retrospective study followed 2,123 dry AMD patients, from five retina specialist practices over a 10-year period, with a goal of understanding visual outcomes of patients participating in the digital healthcare program. Visual acuity (VA) at conversion to wet age-related macular degeneration (AMD) was 20/39, vastly exceeding the mean VA of 20/83 using current standard of care (relying on office visits and patient self-reported symptoms) alone as shown in the American Academy of Ophthalmology’s IRIS® Registry.1 More importantly, the long-term treatment outcomes of patients whose conversion was detected early using ForeseeHome had an average VA of 20/32 after an average of 2.7 years of treatment, a stark contrast to a typical patient’s VA of 20/80 after two years of follow-up using current standard of care as reported earlier1 based on the IRIS Registry.
Wet AMD is the leading cause of blindness in the United States. Despite multiple approved therapies, the long-term real-world outcomes for patients have been underwhelming, often due to late detection of the conversion from dry to wet AMD that can lead to irreversible vision loss at the time of treatment initiation. The ALOFT study was designed to understand if dry AMD patient remote monitoring provides enhanced visual outcomes for this at-risk population through early detection. Study investigators included physicians from the retina specialist practices that participated in the study.
“We expected to see better outcomes with ForeseeHome given the extensive experience we have with the program in our practice, but we were truly amazed by the magnitude of long-term benefit for the patient population,” said Richard Garfinkel, MD, study investigator from Retina Group of Washington. “Adopting a remote monitoring paradigm to augment the customary interval office visit is a game changer for AMD patients.”
The investigators also studied the patient compliance rate, which is extremely important in determining the efficacy of a remote monitoring program. The study showed an average testing frequency of 5.2 ForeseeHome tests per week.
“The excellent compliance rate illustrates the importance of remote patient engagement by the clinically trained staff members at the Notal Vision Monitoring Center,” said Jennifer Jacobs, MD, a medical director at the Monitoring Center. “This testing frequency was maintained for as long as 10 years by patients on the program.”
ForeseeHome uses a unique, proprietary test called peripheral hyperacuity perimetry (PHP), which is highly sensitive in detecting small changes in the retinal structure that may indicate the conversion from dry to wet AMD early. The FDA cleared, AI-enabled device is used by patients at home, between their regularly scheduled eye appointments. The Notal Vision Monitoring Center alerts referring physicians of abnormalities that may warrant an office visit for further diagnostic testing and potential treatment initiation.
“The ALOFT study shows a promising path for millions of dry AMD patients currently at risk of vision loss,” said Kester Nahen, PhD, CEO of Notal Vision. “The service our monitoring center provides to referring physicians and their patients helps protect vision for those who require long-term therapy.”
More details about the ForeseeHome AMD Monitoring program and the Notal Vision Monitoring Center can be obtained at: https://notalvision.com/technology/foreseehome
References:
- Ho AC, Kleinman DM, Lum FC, et al. Baseline Visual Acuity at Wet AMD Diagnosis Predicts Long-Term Vision Outcomes: An Analysis of the IRIS Registry, Ophthalmic Surg Lasers Imaging Retina. 2020;51:633-639.
About Notal Vision
Notal Vision is a diagnostic services company that operates the Notal Vision Diagnostic Clinic, a medical provider with a proven platform for engaging patients and AI-enabled analyses of high-volume personalized health data that extends disease management from the clinic to the home to improve vision outcomes, reduce treatment burden, and improve health economics. www.notalvision.com
The ForeseeHome® AMD Monitoring Program is a comprehensive program, which includes an FDA-cleared device that monitors visual changes in intermediate dry AMD patients at risk of vision loss from undiagnosed wet AMD. The clinical utility for 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 whose diagnosis was at a routine eye exam or a visit triggered by symptoms. Based upon the robust level-1 evidence and compelling clinical outcomes demonstrating the ability to detect choroidal neovascularization (CNV) earlier, the ForeseeHome AMD Monitoring Program gained Medicare coverage in 2016. To learn more, visit www.foreseehome.com.
Notal Vision’s Home OCT system will enable wet AMD patients to perform technician-free OCT testing at home with rapid and self-guided fixation – critical components, especially for elderly patients frequently with pre-existing vision loss. The Notal OCT Analyzer (NOATM), a proprietary machine learning algorithm, developed in-house, performs automated analysis of the Home OCT scans and generates a report to the physician when a physician specified change in disease activity is detected. The Notal Vision Diagnostic Clinic provides referring physicians patient data via an online portal. In addition, physicians will be provided 24/7 access to all of their patients' B-scan images from each Home OCT test with the location of the fluid annotated on each B-scan. Following physician receipt of an alert report, patients may be brought to the office for evaluation and treatment at the doctor’s discretion. NOA can also analyze the output of other commercial OCT devices, and published study data indicate that the performance of NOA in detecting disease activity was similar to that of retina physicians when each was compared to a panel of experts. Notal Vision’s Home OCT has the potential to support current and future advances in retinal disease management.
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