Devices for at-home monitoring for eye conditions such as AMD have been developing over the past few years. The pandemic-related shutdown and resultant delays in seeking care this year have made the need for such patient tools all the more urgent.
Researchers recently compared the real-world use of the ForeseeHome (Notal Vision) monitoring device in detecting conversion from intermediate AMD to neovascular AMD to the published results of a clinical trial (the HOME study). They employed a retrospective analysis of electronic health records from four retina practices in the United States and collected information through the ForeseeHome’s online portal.
Four hundred forty-eight patients (775 eyes) were prescribed use of the device, which was then used on 649 eyes at least once. The records showed that 478 eyes established baseline, and these were significantly younger patients than those who didn’t establish baseline. Among the 478 with baseline data, 126 had an overall inadequate frequency of use (two or more tests per week) and 250 didn’t use the device as frequently as instructed by the manufacturer (three or more tests per week). One hundred twelve patients discontinued use within a year.
“Patient compliance is central to home monitoring and a key reason why we operate a remote diagnostic clinic that monitors the frequency of testing and engages with patients if the required number of tests is not accomplished,” says Kester Nahen, PhD, CEO of Notal Vision. He says a real-world analysis of 5.2 million tests recorded by Notal Vision’s remote clinic showed that patients test on average 5.6 times per week.
In the retrospective study, records indicated that over 20.35 months, 106 patients had 152 alerts, which indicated possible conversions to neovascular AMD. At one clinical site, 136 of 211 eyes that were prescribed the device and that also established baseline had 52 alerts, three of which correctly identified conversion from baseline to wet AMD. Forty-seven were false positives.
Based on comparisons with the prospective HOME study, the researchers concluded that the ForeseeHome’s utility in the real world and in a clinical practice application was undermined by patient inattention to the task. “A meaningful proportion of eyes never used the device or couldn’t establish baseline,” the researchers said. “Overall frequency of use was low and continuous usage of the device decreased over time.”
“Patient dropout is a challenge, especially during the first year, as the authors report,” Dr. Nahen of Notal Vision notes. “Patients need to be motivated to participate in the program. Symptoms of dry AMD are subtle, so patients do not feel an urgency to use the device. Disease education and coaching by the referring physician and the clinical staff of the remote diagnostic clinic are critical to keep patients on board.” The nature of the AMD patient population—elderly individuals with higher rates of deficits in cognition and dexterity—also contribute to noncompliance, Dr. Nahen explains.
He also points out that in this study, on average, 1.7 eyes per patient were tested a reported 3.44 times per week, or a total of 5.9 tests per week per patient (1.7x3.44). “This number is larger than the 4.4 tests per week per patient reported in the HOME study,” he explains. “Therefore, the compliance in the real world was better, not worse, than in the clinical trial.”
The study authors note that “the ForeseeHome device remains an important, first-generation device that represents the invaluable potentially positive impact that home monitoring could have on improving long-term outcomes when managing not only AMD but a host of retinal diseases.”
Yu HJ, Kiernan DF, Eichenbaum D, et al. Home monitoring for age-related macular degeneration: Real-world utility of the ForeseeHome device for detection of neovascularization. Ophthalmology Retina. August 14, 2020. [Epub ahead of print].