A Multimodal AI Agent for Ophthalmic Clinical Decision Support

Sponsored by The Hong Kong Polytechnic University

About this trial

Last updated 3 months ago

Study ID

PolyU-IRB-2025-001

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

6 to 75 Years

All Sexes

Trial Timing

Started 3 months ago

What is this trial about?

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.

What are the participation requirements?

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.