A Multimodal AI Agent for Ophthalmic Clinical Decision Support

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-75
SponsorThe Hong Kong Polytechnic University

About this trial

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 criteria

Qualifiers

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.

Participants aged 18 years or older provide their own consent.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EyeAgent AI system

Treatment groups

300 Participants
are divided into 2 treatment groups