New Real-World Data Shows AEYE-DS Autonomous AI Achieving a 96% Success Rate (Imageability) Without Dilation in a High-Traffic Endocrinology Clinic

NEW YORK, Aug. 4, 2026 /PRNewswire/ -- AEYE Health, the leader in ophthalmic AI and retinal diagnostics and the developer of AEYE-DS, today announced the publication of a new study in the British Journal of Ophthalmology. The prospective, real-world study demonstrates that the AEYE Diagnostic Screening (AEYE-DS) system integrates into busy endocrinology workflows, achieving 96% success rate ("imageability") without the need for pharmacological eye dilation, using the Topcon NW500 non-mydriatic camera.

The investigator-led study, titled "Real-world integration of an autonomous artificial intelligence system for diabetic retinopathy screening in an endocrinology outpatient clinic," was designed and conducted by clinical researchers at the Division of Endocrinology, Diabetes and Metabolism of Sheba Medical Center in Israel, in collaboration with the Icahn School of Medicine at Mount Sinai in New York, examining 256 adult diabetes patients at the point of care. The study was made possible through a collaboration between AEYE Health and ARC Innovations, the innovation arm of Sheba Medical Center.

Overcoming the "Achilles' Heel" of Diabetic Eye Screening

Diabetic retinopathy (DR) is the leading cause of preventable vision loss among working-age adults in the US. While clinical guidelines recommend annual dilated eye exams for all patients with diabetes, more than 60% of patients miss their annual eye exam due to numerous reasons including a shortage of specialists, geographic barriers to care, and complex scheduling hurdles.

The solution lies in shifting screening directly to the patient's point of care during routine check-ups, effectively freeing up specialists to focus on treatment. However, in a fast-paced clinic, the defining measure of success for this model is imageability, which represents the technology's ability to consistently deliver a definitive result without requiring specialized operators.

In this study, using AEYE-DS in conjunction with the automated Topcon NW500 non-mydriatic camera, a single novice operator with just one hour of training successfully obtained results for 95.7% of patients under ambient lighting. This real-world, fully dilation-free result externally validates earlier clinical trial data announced in partnership with Topcon Healthcare, Inc., which demonstrated 100% imageability and >99% first-attempt success without dilation using the Topcon NW500.

"Limited imageability has long been the Achilles' heel of diabetic retinopathy screening programs," said Dr. Gal Yaakov Cohen, the study's corresponding author, of the Icahn School of Medicine at Mount Sinai and the Goldschleger Eye Institute. "What impressed us was how consistently AEYE-DS overcame it: in a busy, endocrinology clinic, it obtained a definitive result for the majority of patients without dilation, in the hands of staff with just one hour of training. That allows us to screen patients who would otherwise miss their vital annual diabetic eye exam."

Prof. Amir Tirosh, Director of the Endocrinology Institute at Sheba Medical Center, added: "Beyond diabetes management, offering point-of-care eye screening allows us to provide truly comprehensive care under one roof. Screening patients on the spot saves them dedicated clinic visits, guarantees they get checked, and ultimately protects their vision before sight-threatening damage occurs."

Key Study Findings:

• 95.7% Imageability, No Dilation: a definitive result for 95.7% (245 of 256 patients), on a compact, tabletop camera, by a novice operator.
• Point-of-Care Detection: By screening patients during their routine endocrinology visit, AEYE-DS identified patients at the point of care who would otherwise have required a separate, dedicated eye exam to be found. Confirmed cases needing immediate, sight-saving treatment (anti-VEGF therapy or panretinal photocoagulation) were fast-tracked into care through the study's referral pathway.
• 90% Satisfaction: Patient satisfaction with AI screening was high. Patients reported a mean rating of 4.5 out of 5, with 89% finding it easy to use, and 90% said they would recommend the screening to other patients with diabetes.

Closing the Clinical Loop

The study's true impact lies in its real-world implementation, proving that AEYE-DS' autonomous AI can seamlessly embed into high-volume clinics without disrupting workflows. Crucially, the protocol eliminated routine dilation; patients whose scans weren't gradable were automatically routed to general ophthalmology for a dilated exam. For the 95.7% gradable scans, the system generated ready-made interpretive notes for the endocrinologist to incorporate into the visit note, and triggered a two-way coordination loop with the retina clinic for positive results. Ultimately, this provides a highly scalable blueprint for health systems: a practical, point-of-care pathway that works on the front lines of diabetes care, protecting specialist capacity while expanding patient access.

"Demonstrating 96% imageability without dilation in a real-world setting - in this case a fast-paced endocrinology clinic - underscores the prowess of our deep-learning algorithms and AEYE-DS," said Zack Dvey-Aharon, Ph.D., Co-founder and CEO of AEYE Health. "This study is a blueprint for how health systems can scale point-of-care screening to help prevent blindness caused by diabetes. These are exciting times for us as AEYE-DS continues to expand quickly all across the United States."

About AEYE Health

AEYE Health is a digital health company delivering fully autonomous AI-based diagnostic screening solutions for retinal imaging, with best-in-class clinical results and superior usability. Its diabetic retinopathy screening solution, AEYE-DS, is the fastest growing solution in the US for diabetic eye exams. The company aims to make diagnostic screening practical, accurate, and accessible. AEYE Health enables point-of-care screening for diabetic retinopathy, helping ensure that patients with diabetes are screened regularly. AEYE-DS is the only FDA-cleared autonomous AI for diabetic retinopathy that requires just 1 image per eye and the only approved AI for a portable camera. A pioneer and leader in Oculomics, AEYE Health's AEYE-X is a comprehensive health assessment platform that screens for more than 100 indications, making it the industry's broadest and most advanced Oculomics platform.

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SOURCE AEYE Health