Study Develops and Validates Handheld Device to Screen for Macular Degeneration

A newly designed, unique monocular standalone device for remote testing and monitoring of age-related macular degeneration (AMD) has been developed through a recent study, which also clinically validated the device in 30 dry AMD patients.¹

Presented at the 43^rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, by Yannis Paulus, MD, Johns Hopkins University, Wilmer Eye Institute, this study was driven by AMD’s position as the leading cause of irreversible vision loss in American adults.¹

AMD is a leading cause of blindness and is typically driven by advancing age. Severity of vision loss ranges from mild to severe, and the number of cases is expected to rise significantly with the aging global population. The disease involves pathological changes to the deeper retinal layers of the macula and surrounding vasculature, which results in central vision loss. The accumulation of drusen are a widely accepted advanced sign of dry AMD.²

Existing methods, such as the Amsler grid, ForeseeHome, the prototype Home OCT and SELFF-OCT, have various limitations. Paulus and colleagues worked to develop a novel, handheld, standalone device utilizing shape discrimination hyperacuity to remotely monitor AMD and performed a clinical validation in an outpatient dry AMD population to evaluate ease of use and comfort.¹

The cross-sectional study was conducted with 32 patients, all of whom were over 50 years old, at the University of Michigan Kellog Eye Center outpatient clinic. Participants were given a standardized tutorial on using the device and subsequently used it on the eyes with dry AMD. Investigators recorded the duration of the test. Patients were then given a device survey composed of 8 questions utilizing a Likert scale and a standardized System Usability Scale survey.¹

The device itself is comprised of an injection-molded 3D-printed shell with 2 tactile buttons, a battery, a Raspberry Pi 3 processing unit, and a 1.5-inch RGB OLED screen. The device presents patients with a series of circular images and a prompt of whether the image displayed previously was a perfect circle. They responded to these questions by pushing the corresponding button – their responses were collected and analyzed longitudinally to measure changes in minimum distortion-detection thresholds.¹

A total of 31 subjects finished the study, with 1 withdrawing post completion. Mean (standard deviation [SD]) age was 77 years (SD 7.9 years). Gender was evenly split between male and female. Mean testing time was 2 minutes and 6 seconds (SD 57 seconds). Of the participants, 5 had dry AMD in both eyes and used the device on both; testing duration exhibited a 37% reduction between the two uses (mean eye 1 time = 2 minutes 8 seconds; mean eye 2 time = 1 minute 24 seconds).¹

97% of patients reported an acceptable test duration and 90% reported comfort while using the device. Mean System Usability Scale score was 77.7 (SD 11.9), which suggests a higher usability than all others. 97% of patients reported the learning process was easy, and 100% were confident that other patients could easily learn to use the device.¹

Investigators noted this study as the first description and validation study of a device of this type. Based on patient responses, the device can provide rapid, easy, and comfortable testing for dry AMD. Given that the device also does not rely on smartphone or tablet technology, it is uniquely standalone compared to other common alternatives.¹

“The usability of the device supports further clinical trials to demonstrate the device’s ability to reliably detect progression of AMD,” Paulus and colleagues wrote.¹

References

1. Paulus Y. Novel Handheld Device for Remote Monitoring of Non-neovascular Age-Related Macular Degeneration and Clinical Validation of Usability and Comfort. Abstract presented at the 43^rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, July 30-August 2, 2025.

2. Thomas CJ, Mirza RG, Gill MK. Age-Related Macular Degeneration. Med Clin North Am. 2021;105(3):473-491. doi:10.1016/j.mcna.2021.01.003