OphthalmologyNCT07401459
A Multimodal AI Agent for Ophthalmic Clinical Decision Support
A study testing EyeAgent AI system in people with Ophthalmology and Large Language Models, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ophthalmology, Large Language Models, AI Agent
- What is being tested?
- EyeAgent AI system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Danli Shi, Dr contact
China1 site
The Hong Kong Polytechnic University
Hong Kong
Xiaolan Chen, 085295822773, xiaolan-xl.chen@connect.polyu.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Ophthalmology, Large Language Models, AI Agent, Eye Disease, Retinal Disease
- Being tested
- EyeAgent AI system
- Keywords
- medical AI agent, large language model, ophthalmology, tool integration, clinical decision support, real world study
- Medical subject headings
- Eye Diseases, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeAgent AI systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted care arm | Experimental | Clinicians perform report generation, diagnosis, and treatment planning with support from the EyeAgent system. Receives: Device: EyeAgent AI system |
| Standard care arm | No intervention | Clinicians provide routine ophthalmic care without support from the EyeAgent system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy rate
Proportion of diagnoses consistent with a reference expert panel.
Measured: 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.
Measured: Immediately after the intervention.
Secondary outcomes (4)
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.
Measured: 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).
Measured: Immediately after the intervention.
Workflow efficiency
Time elapsed from image acquisition to final diagnosis and report completion.
Measured: During the index diagnostic session.
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.
Measured: At the end of each clinician's participation period, approximately 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingguang He, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401459
- Sponsor's protocol ID
- PolyU-IRB-2025-001
- Status last verified
- Sep 2025
- First submitted
- 17 Nov 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial of a Multimodal AI Agent for Ophthalmology Clinical Decision Support
- ClinicalTrials.gov ID
- NCT07401459
- Acronym / sponsor ID
- PolyU-IRB-2025-001
- Conditions
- Ophthalmology, Large Language Models, AI Agent, Eye Disease, Retinal Disease
- Keywords
- medical AI agent, large language model, ophthalmology, tool integration, clinical decision support, real world study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted care arm | Experimental | Device: EyeAgent AI systemClinicians perform report generation, diagnosis, and treatment planning with support from the EyeAgent system. |
| Standard care arm | No intervention | –Clinicians provide routine ophthalmic care without support from the EyeAgent system. |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyeAgent AI systemEyeAgent 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. | Device | AI-assisted care arm |
Primary outcome
Diagnostic accuracy rate
Time frame: Immediately after the intervention.
Proportion of diagnoses consistent with a reference expert panel.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danli Shi, Dr contact
Mingguang He principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EyeAgent AI system in people with Ophthalmology and Large Language Models, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolan Chen (+85295822773, yuewy.wu@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy rate (time frame: Immediately after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.