A Multimodal AI Agent for Ophthalmic Clinical Decision Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EyeAgent AI system.
- Who it may be relevant to
- Registry conditions: Ophthalmology, Large Language Models, AI Agent, Eye Disease. Basic parameters: 6 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Randomized Controlled Trial of a Multimodal AI Agent for Ophthalmology Clinical Decision Support
Overview
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.
Detailed description
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.
Interventions
- Device 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.
Primary outcome measures
- Diagnostic accuracy rate [Time frame: Immediately after the intervention.]
- Rate of inappropriate treatment decisions [Time frame: Immediately after the intervention.]
Secondary outcome measures (4)
- Report quality [Time frame: Within 1 month after enrollment.]
- Clinician confidence [Time frame: Immediately after the intervention.]
- Workflow efficiency [Time frame: During the index diagnostic session.]
- Satisfaction and usability [Time frame: At the end of each clinician's participation period, approximately 2 months.]
Eligibility criteria
Inclusion criteria
- Outpatient participants aged 6 to 75 years.
- Participants who undergo ophthalmic examinations for medical purposes during the study period.
- Participants who can produce clear ophthalmic images in both eyes.
- Agree to participate in this study with written informed consent:
- Participants aged 18 years or older provide their own consent.
- Participants aged 6-17 years require consent from a parent or legal guardian.
Exclusion criteria
- Participants who are reluctant to participate in this study.
- Participants presenting with acute or emergency ocular conditions requiring immediate intervention.
- Participants with poor quality of ophthalmic images, including blurriness, artifacts, underexposure, or overexposure.
- Other unsuitable reasons determined by the evaluators.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
China · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT07401459 · PolyU-IRB-2025-001