A Multimodal AI Agent for Ophthalmic Clinical Decision Support

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Retinal Disease; Eye Disease; Ophthalmology; AI Agent; Large Language Models
• Intervention / Treatment: Device: EyeAgent AI system

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaolan Chen; Phone Number: +85295822773; Email: yuewy.wu@connect.polyu.hk
• Study Contact Backup: Name: Danli Shi, Dr; Email: danli.shi@polyu.edu.hk

Study Locations

• China
  • Hong Kong, China
    • The Hong Kong Polytechnic University
    • Contact: Xiaolan Chen; Phone Number: 085295822773; Email: xiaolan-xl.chen@connect.polyu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-assisted care arm; Clinicians perform report generation, diagnosis, and treatment planning with support from the EyeAgent system.	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.
No Intervention: Standard care arm; Clinicians provide routine ophthalmic care without support from the EyeAgent system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy rate	Proportion of diagnoses consistent with a reference expert panel.	Immediately after the intervention.
Rate of inappropriate treatment decisions	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.	Immediately after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Workflow efficiency	Time elapsed from image acquisition to final diagnosis and report completion.	During the index diagnostic session.
Report quality	Quality of clinical reports assessed using a structured Expert Report Quality Rubric evaluating five domains: accuracy, completeness, safety, reasoning, and interpretability. Each domain is scored on a 3-point scale (1 = poor, 2 = acceptable, 3 = good). Total scores range from 5 to 15. Higher scores indicate better report quality.	Within 1 month after enrollment.
Clinician confidence	Self-rated confidence in diagnosis and treatment planning measured using a single-item 5-point Likert scale (1 = not confident at all; 5 = extremely confident).	Immediately after the intervention.
Satisfaction and usability	Usability of the AI agent assessed using the System Usability Scale (SUS), a validated 10-item questionnaire scored on a 5-point Likert scale. Each item is scored from 1 (Strongly disagree) to 5 (Strongly agree). Total SUS scores are calculated according to standard scoring procedures and range from 0 to 100, with higher scores indicating better perceived usability.	At the end of each clinician's participation period, approximately 2 months.

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Mingguang He, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: clinical decision support; ophthalmology; real world study; large language model; medical AI agent; tool integration
• Additional Relevant MeSH Terms: Retinal Diseases; Eye Diseases
• Other Study ID Numbers: PolyU-IRB-2025-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No