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Multicenter Randomized Controlled Trial of a Multimodal AI Agent for Ophthalmology Clinical Decision Support
This study is a multicenter randomized controlled trial evaluating the effectiveness and safety of EyeAgent, a multimodal artificial intelligence (AI) agent designed to assist ophthalmologists in clinical decision-making. Participants will be recruited from ophthalmology clinics and hospitals in Hong Kong and mainland China. The AI agent acts as a digital co-pilot, analyzing patient images and clinical history to provide diagnostic and management recommendations. The trial aims to determine whether the use of the AI agent improves diagnostic accuracy, treatment decision-making performance, report generation, workflow efficiency, and user satisfaction compared to standard clinical practice.
This multicenter, randomized controlled trial aims to evaluate the integration of EyeAgent, a multimodal artificial intelligence (AI) agent, in real-world clinical settings. The AI system is designed to support clinicians by analyzing patient data, including ocular images and electronic health records, to aid in image interpretation, diagnosis, and treatment planning. A total of 300 participants will be randomly assigned to either an AI-assisted care arm or a standard care arm. In the AI-assisted arm, clinicians review the comprehensive report generated by AI agent as a supportive tool before finalizing their independent decisions. The study comprehensively measures diagnostic accuracy, the rate of inappropriate treatment decisions, report generation, workflow efficiency, and user questionnaire. By comparing these two groups, the trial aims to provide robust evidence on the effectiveness and practical utility of AI-driven clinical decision support in ophthalmology, with the goal of enhancing both the quality and efficiency of patient care.
Age
6 - 75 years
Sex
ALL
Healthy Volunteers
Yes
The Hong Kong Polytechnic University
Hong Kong, China
Start Date
March 1, 2026
Primary Completion Date
October 31, 2026
Completion Date
December 31, 2026
Last Updated
February 23, 2026
300
ESTIMATED participants
EyeAgent AI system
DEVICE
Lead Sponsor
The Hong Kong Polytechnic University
NCT07234539
NCT05294640
Data Source & Attribution
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