Oculocare Medical Inc. offers Alleye, a mobile medical software application that can detect, characterize, and track progression of central and paracentral metamorphopsia, a visual distortion in patients with age-related macular degeneration (AMD) and diabetic retinopathy. It is also recommended for individuals aged 55 years and older who are at risk for these diseases. Patients use the app to regularly perform simple self-tests at home to independently monitor their eyesight.

“This test is perfect for patients diagnosed with AMD who want to be sure to schedule a doctor’s visit at the right time,” says Barbara C. Bachmann, MD, an ophthalmologist and fellow of the European Board of Ophthalmology. “When patients with dry AMD whose condition is under control use Alleye, I only need to see them once a year compared to every 3 to 4 months when they don’t use the app to regularly monitor their eyesight. For patients undergoing treatment for wet AMD, particularly when monthly injections are no longer needed and treatment intervals can be extended, the ability to easily self-test with this app helps to identify if a disease has progressed and if a patient should return sooner for a follow-up visit.”

Patients who have relatives with advanced AMD frequently ask Dr. Bachmann what they can do to prevent or detect disease. “Alleye finally gives me something to offer them,” she says.

Recommendation by an eye care professional is required for patients to access Alleye. An annual license is required to connect the Alleye app to an eye care professional’s account. Alleye received US Food and Drug Administration approval in July 2018.

HOW IT WORKS

Health care staff can install the Alleye app on a patient’s smartphone or tablet and demonstrate how to perform the self-test, says Lucas Bachmann, CEO of Oculocare Medical Inc. Patients can practice using the app in training mode. When using Alleye, patients should sit at a table and hold the device 20 cm to 40 cm away from their face.

Jonas Stemmle, MD, a senior ophthalmologist practicing in Switzerland who recommends the app to his patients, suggests they take the test — which is similar to an Amsler grid test — once a day or once a week.

Alleye assesses hyperacuity using an alignment task. Users are asked to align a middle dot with 2 outer dots on an invisible straight line, explains Dr. Bachmann. This task is repeated 3 times in differing positions, with different distances between central and flanking dots in horizontal, vertical, and oblique axes. The app measures Vernier-Visus acuity, which measures the ability to align 2 line segments and detects misalignment of the axis.

Patients can review results on their mobile device. The distance of every measurement is added together, and then the app provides a summary of misalignment, including a numerical score as well as a color scheme system in which green indicates a stable or improving condition and red indicates a considerable worsening of performance compared to a previous test result, Dr. Bachmann says. Results are compared to prior measurements via a chart showing trends in measurements. The maximum score of 100 indicates the patient’s visual performance is as high as typically found among healthy subjects; the minimum score is 0. The color changes from green to red if the score drops by 25 points or more.

Three consecutive “red” tests indicate sustained low performance. “If this occurs, patients should contact their eye care professional,” Dr. Stemmle says. Eye care providers can assess tests results, which are automatically transmitted after a patient completes a test and connects to a web application. Dr. Stemmle, who contacts patients when vision deterioration occurs, says the app provides extra safety to ensure he doesn’t miss any patient’s decline in vision.

PATIENT BENEFITS

Alleye detects deteriorating eyesight before patients notice it themselves. “By enabling patients to check their own eyesight, it helps ensure that a possible deterioration will not go undetected,” Dr. Stemmle says, adding that Alleye shouldn’t replace regular check-ups with an eye care specialist.

In 3 clinical studies,^1-3 124 elderly patients with AMD evaluated the app’s usability. Patients provided oral feedback on its user friendliness and completed a system usability scale. The mean score of 85 out of 100 represented excellent usability.

“Alleye is among the few health apps available from app stores that underwent rigorous clinical evaluation,” says Lucas Bachmann. “The app’s development was based on a principled approach where both testing performance and usability were the focus.”

Dr. Stemmle says patients with wet AMD shouldn’t wait until their vision declines to seek treatment — treatment should start as early as possible, which means before vision actually declines. “Alleye picks up a worsening case of wet AMD before vision deteriorates, allowing patients to start treatment sooner and have better visual outcomes,” he says.

Dr. Bachmann says patients who use the app welcome the opportunity to monitor their disease. “It gives them a good feeling to be able to contribute to the betterment of their eyesight,” she says. RP

REFERENCES

1. Schmid MK, Faes L, Bachmann LM, Thiel MA. Accuracy of a self-monitoring test for identification and monitoring of age-related macular degeneration: a diagnostic case-control study. Open Ophthalmol J. 2018;12:19-28. doi: 10.2174/1874364101812010019.
2. Lienhard KR, Legner C. Principles in the design of mobile medical apps: guidance for those who care. Presented at the 13th International Conference on Wirtschaftsinformatik; February 12-15, 2017;St. Gallen, Switzerland. https://www.wi2017.ch/images/wi2017-0296.pdf . Accessed October 2, 2018.
3. Schmid MK. Sensitivity and positive predictive value of self-measurement with Alleye to detect worsening of wet AMD. Poster presented at: American Academy of Ophthalmology Annual Meeting; November 11-14, 2017; New Orleans, LA, Abstract PO451.