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NCT Number: NCT07401459

A Multimodal AI Agent for Ophthalmic 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.

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Key information

Conditions

Ophthalmology AI Agent Eye Disease Eye Diseases Large Language Models Retinal Disease Retinal Diseases

Age range

6 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EyeAgent AI system

Device

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 outcomes

  1. Diagnostic accuracy rate

    Time frame: Immediately after the intervention.

    Proportion of diagnoses consistent with a reference expert panel.

  2. Rate of inappropriate treatment decisions

    Time frame: 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.

Secondary outcomes

  1. Report quality

    Time frame: Within 1 month after enrollment.

    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.

  2. Clinician confidence

    Time frame: Immediately after the intervention.

    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).

  3. Workflow efficiency

    Time frame: During the index diagnostic session.

    Time elapsed from image acquisition to final diagnosis and report completion.

  4. Satisfaction and usability

    Time frame: At the end of each clinician's participation period, approximately 2 months.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danli Shi, Dr

CONTACT

[email protected]

Xiaolan Chen

CONTACT

[email protected]

+85295822773

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Multicenter Randomized Controlled Trial of a Multimodal AI Agent for Ophthalmology Clinical Decision Support

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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