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AI-Assisted Detection of Posterior Segment Diseases: DR, AMD, RVO, and Glaucoma
Sponsor: Inje University
Summary
The purpose of this multi-center study is to evaluate the extent to which AI-assisted fundus image interpretation improves the diagnostic performance of ophthalmologists. Rather than assessing the standalone algorithm performance, this study aims to determine the clinical value of using AI as a decision-support tool within actual clinical workflows. At each participating institution, five ophthalmologists within three years of board certification and five ophthalmology residents will participate as readers. All readers will interpret fundus images both with and without the AI-based assistance software. The study will quantitatively compare diagnostic accuracy and reading time across the two conditions for four posterior segment diseases: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, and glaucoma.
Official title: A Multicenter Clinical Study to Validate the Performance Improvement of Fundus Photography Reading Software
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-02-20
Completion Date
2026-05-30
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
VUNO Med-Fundus AI
The intervention consists of an AI-based fundus image interpretation software that provides automated outputs for 12 retinal and optic nerve findings (e.g., hemorrhage, exudates, drusen, optic disc change). The system does not generate a direct disease diagnosis. Instead, the AI displays the presence or absence of 12 predefined findings along with their lesion locations. Readers may use this finding-level information as decision-support when determining the presence of the four target diseases (diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, and glaucoma).
Locations (5)
Inje University Busan Paik Hospital
Busan, South Korea
Dong-A University Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea