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An FDA-approved device, provided to eligible patients with age-related macular degeneration, showed ability to detect CNV risks over 5 years.
Home monitoring for incident neovascular age-related macular degeneration (nAMD) may be a viable long-term option for older patients with the use of a regulated at-home screening device, according to new research.
A five-plus year assessment of the ForeseeHome Preferential Hyperacuity Perimeter (PHP), provided to older patients with AMD who are at risk of progression to blindness via choroidal neovascularization (CNV), show the product is dependable for remote detection and initiated care of neovascularization.
The findings come at a time when remote monitoring and screening rates have increased significantly during the COVID-19 pandemic—as well as on the precipice of rapidly increasing cases of AMD and diabetes-related progression to blindness in the older US population.
Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Virtual Sessions this week, investigators conducted the prospective cohort study to evaluate the frequency of at-home detections of CNV conversion in patients with intermediate over a lengthy period of time.
Their selected device for CNV detection was the PHP, originally approved by the US Food and Drug Administration (FDA) for at-home detection in 2009.
Past research indicated that a qualifying test conducted in physicians’ offices could identify patients most likely to use the PHP device successfully. Qualified patients who were able to establish a baseline score with the device could then proceed with daily home use.
“AMD with CNV is a leading cause of blindness, necessitating early treatment before significant vision loss occurs,” investigators wrote. “The PHP is FDA-approved to aid in home monitoring for CNV related to AMD.”
Led by Marcus Altman, MD, of the Casey Eye Institute at Oregon Health & Science University, investigators observed such qualified patients aged ≥55 years old with intermediate AMD and visual acuity ≥20/63 in the study eye.
Monitoring spanned 5 years and could trigger an in-office visit via device alert or the report of a visual symptom. Patients who had no detected CNV at the visit could re-establish a baseline with the device to continue home testing.
The study included 91 qualified patients. Mean age was 73.1 years old, with a visual acuity of 20/28. Of these patients, 132 study eyes established a baseline to begin home assessment.
Another 54 eyes (41%) had at least 1 alert by either symptom or device notification over 5 years. Of 90 device-triggered follow-ups, 83 (92%) were false positives, while 7 (8%) led to the detection of CNV. Mean enrollment duration at time of CNV detection was 2.1 years.
Investigators additionally observed 2 eyes that developed CNV diagnosed only by symptoms and without a device alert. Mean visual acuity at CNV detection was approximately 20/32.
Another 23 eyes with a false-positive alert had withdrawn from the trial due to failure to re-establish baseline. Of those eyes, 6 (26%) developed CNV in a mean 2.7 years afterward.
Altman and colleagues reported PHP devices were used about 15 times monthly on average—a rate which was greater in the first year of patient enrollment versus the last year (18.5 vs 12.8; difference, 5.7; 95% CI, 3.5 – 7.9; P <.001).
The team concluded that, despite a 22% false negative rate, the PHP device was capable of providing patient and physician confidence in neovascularization risk-monitoring from the confines of home in the appropriate patients with AMD.
“These data over 5 years suggest a large proportion of incident neovascular AMD cases were detected by home monitoring, and eyes monitored by the device had good visual acuity at time of CNV detection,” they wrote.
The study, “5-Year Results of a Home Monitoring Device in Study Participants at High Risk for Neovascular Age-related Macular Degeneration,” was presented at ARVO 2021