New York, August 4, 2026
AEYE Health has announced the publication of a real-world clinical study in the British Journal of Ophthalmology demonstrating that its FDA-cleared AEYE Diagnostic Screening (AEYE-DS) autonomous artificial intelligence system achieved a 96% imageability success rate without pharmacological dilation in a busy endocrinology outpatient clinic. Conducted by researchers at Sheba Medical Center in collaboration with the Icahn School of Medicine at Mount Sinai, the prospective study evaluated 256 adults with diabetes using the Topcon NW500 non-mydriatic retinal camera. The findings highlight the ability of AEYE-DS to integrate seamlessly into routine diabetes care while enabling rapid, point-of-care screening for diabetic retinopathy (DR), one of the leading causes of preventable blindness among working-age adults. The study reinforces the growing role of autonomous AI-powered diagnostics in expanding access to early disease detection while reducing reliance on specialist eye examinations.
Real-World Study Demonstrates High-Performance AI Screening
The investigator-led study assessed the implementation of AEYE-DS within a high-volume endocrinology clinic where retinal screening was performed during routine diabetes appointments. Researchers found that a single novice operator, following only one hour of training, successfully obtained diagnostic-quality retinal images for 95.7% of patients without requiring pupil dilation. This high imageability rate demonstrates the effectiveness of combining AEYE-DS with the Topcon NW500 non-mydriatic camera, enabling efficient retinal imaging under normal clinical conditions. The findings also validate previous clinical trial results showing excellent performance without dilation and confirm that autonomous AI systems can operate successfully in real-world healthcare environments. By embedding retinal screening directly into diabetes clinics, healthcare providers can identify patients requiring ophthalmic referral earlier while minimizing workflow disruption and reducing dependence on specialized eye care resources.
AI Improves Early Detection and Patient Access
Diabetic retinopathy remains one of the most common complications of diabetes and is a major cause of preventable vision loss worldwide. Despite recommendations for annual retinal examinations, many patients fail to receive regular eye screening because of limited specialist availability, scheduling barriers, and geographic challenges. The study demonstrated that AEYE-DS enables clinicians to identify patients requiring urgent ophthalmic intervention during their routine endocrinology visits. Individuals with positive findings were rapidly referred for sight-preserving treatments, including anti-VEGF therapy and panretinal photocoagulation, while patients whose retinal images could not be graded were automatically directed for comprehensive ophthalmic examination. Patient acceptance of the technology was equally encouraging, with approximately 90% of participants recommending AI-based screening and reporting a positive experience. These findings suggest that autonomous AI screening can significantly improve patient access while supporting earlier diagnosis and treatment of diabetic eye disease.
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Autonomous AI Strengthens Point-of-Care Ophthalmology
The publication further strengthens AEYE Health’s position as a leader in autonomous AI-driven retinal diagnostics and digital healthcare innovation. AEYE-DS, currently one of the fastest-growing FDA-cleared autonomous AI solutions for diabetic retinopathy screening in the United States, requires only one retinal image per eye and is approved for use with portable imaging systems, enabling broader deployment across primary care, endocrinology, and community healthcare settings. The study provides healthcare systems with a practical implementation model that integrates artificial intelligence, retinal imaging, and automated clinical reporting into existing diabetes management workflows. By reducing unnecessary referrals while rapidly identifying patients requiring specialist intervention, AEYE-DS has the potential to optimize ophthalmology resources and expand preventive eye care services. As AI continues transforming medical diagnostics, the real-world evidence generated by this study demonstrates how autonomous technologies can improve healthcare efficiency while helping prevent vision loss among patients living with diabetes.
Source: AEYE Health press release
