OphthalmologyLarge Language ModelsAI AgentEye DiseaseRetinal Disease
Investigational drug(s) / intervention(s)
EyeAgent AI system
EyeAgent AI system: EyeAgent is a multimodal AI agent assistant for ophthalmology that integrates imaging, electronic health records, and curated clinical knowledge. In this arm, EyeAgent supports clinicians in clinical consultation, including report generation, diagnostic interpretation, and treatment planning.
Study summary
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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Outpatient participants aged 6 to 75 years.
2. Participants who undergo ophthalmic examinations for medical purposes during the study period.
3. Participants who can produce clear ophthalmic images in both eyes.
4. Agree to participate in this study with written informed consent:
1. Participants aged 18 years or older provide their own consent.
2. Participants aged 6-17 years require consent from a parent or legal guardian.
Exclusion Criteria:
1. Participants who are reluctant to participate in this study.
2. Participants presenting with acute or emergency ocular conditions requiring immediate intervention.
3. Participants with poor quality of ophthalmic images, including blurriness, artifacts, underexposure, or overexposure.
4. Other unsuitable reasons determined by the evaluators.
Primary outcome measure(s)
Diagnostic accuracy rate — Immediately after the intervention. Proportion of diagnoses consistent with a reference expert panel.
Rate of inappropriate treatment decisions — Immediately after the intervention. The frequency of treatment recommendations (e.g., injection, laser therapy, or observation) that deviate from clinical guidelines as determined by the senior expert panel gold standard. Expert adjudication is conducted post-hoc after the enrollment phase concludes.
Trial sites (1)
Facility
City
Region
Status
The Hong Kong Polytechnic University
Hong Kong
China
More The Hong Kong Polytechnic University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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