The study is one of the first clinical trials to validate the clinical utility of real-world remote physiologic monitoring using an on-demand vision-as-a-service extension to the specialty retina clinic to enable remote monitoring of patients with chronic diseases such as AMD, diabetic retinopathy, and other retinal conditions.
KYS Vision Inc. this week announced clinical trial results of its Macustat macular function scan for the remote monitoring of central retinal function. The study was published in the peer-reviewed journal Digital Health1 in October.
According to a news release, The study is one of the first clinical trials to validate the clinical utility of real-world remote physiologic monitoring using an on-demand vision-as-a-service (VaaS) extension to the specialty retina clinic to enable remote monitoring of patients with chronic diseases such as AMD, diabetic retinopathy, and other retinal conditions. Macustat is a part of a suite of cloud-based VaaS digital health applications which includes remote monitoring tests for glaucoma, AMD, DME, and other chronic conditions.
In the clinical study, 50 eyes were evaluated with the self-administered Macustat test and compared to office-based retinal examination, which included OCT imaging of the retina. The self-administered home test was accessed through the KYS Vision Platform on a device-agnostic screen of a smart phone, tablet, laptop, desktop, or other consumer peripheral with internet access. Central visual function was assessed with the multimodal Macustat test using dynamic virtual Amsler grid testing, hyperacuity perimetry, and visual acuity testing—all delivered via a remote telehealth interface. With the self-test, 96% of eyes registered central retina acuity within 0.2 LogMAR of office acuity measurement while the performance efficacy for the detection of macular function defects such as metamorphopsias and scotomas exceeded 90%.
According to Ronald G. Gentile, clinical professor of ophthalmology at New York Eye and Ear of Mount Sinai and principal investigator, age-related macular degeneration and diabetic retinopathy are the top leading causes of blindness. In the United States, about 20 million people are at risk for going blind from these diseases, which is expected to increase as our population ages and we struggle with obesity.
“Worldwide, we expect even greater challenges from these two diseases. Empowering the patient with tools for detecting problems before significant vision loss occurs on an easily accessible platform is key,” he said in a statement. “The Macustat is demonstrating encouraging results in our retina practices as an on-demand, accessible, and clinically meaningful monitoring application.”
Moreover, Ranya Habash, assistant professor of ophthalmology and medical director of technology innovation at Bascom Palmer Eye Institute and co-author, noted that the test of central retinal function delivered via a telemedicine platform demonstrates high concordance with clinical findings from the in-office retina exam.
“I see enormous applications of such digital health tools not only for patient care but for population health initiatives where exponential technology can deliver both scale and access,” she said in a statement.
1. Chen E, Mills M, Gallagher T, Ianchulev S, Habash R, Gentile RC. Remote patient monitoring of central retinal function with MACUSTAT: A multi-modal macular function scan. DIGITAL HEALTH. 2022;8. doi:10.1177/20552076221132105