Systemic Health RiskLifeEye-RCTNCT07890922
AI-Assisted Systemic Health Risk Assessment in General Ophthalmology
A study testing AI-Assisted Health Risk Information in people with Systemic Health Risk, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This study will evaluate whether providing ophthalmologists with additional artificial intelligence (AI)-assisted health risk information derived from routine retinal images affects subsequent clinical care in adults attending general ophthalmology clinics. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Health Risk
- What is being tested?
- AI-Assisted Health Risk Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2026to 28 Feb 2027
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40 years or older.
- Attending a participating general ophthalmology clinic for ophthalmic care.
- At least one routinely acquired ophthalmic image suitable for analysis is available.
- Able to provide informed consent.
- Able to participate in follow-up approximately 30 and 90 days after enrollment.
Who cannot join
- Unable to provide informed consent.
- An ophthalmic or systemic medical emergency requiring immediate care.
- Available ophthalmic images are unsuitable for analysis.
- Previous enrollment in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Wei Wang, PhD, +86-20-87334687, wangwei@gzzoc.com
Wei Wang, PhD
About this study
Official title: Clinical Effectiveness of AI-Assisted Systemic Health Risk Assessment in General Ophthalmology: A Multicenter Pragmatic Clinician-Cluster Randomized Controlled Trial
This study will evaluate whether providing ophthalmologists with additional artificial intelligence (AI)-assisted health risk information derived from routine retinal images affects subsequent clinical care in adults attending general ophthalmology clinics. Participating ophthalmologists will be assigned to either usual ophthalmic care or usual ophthalmic care with access to supplementary information generated by an AI system. The AI system does not independently diagnose disease or determine treatment. All clinical decisions remain the responsibility of the ophthalmologist. Participants will receive routine ophthalmic care and will be followed after the ophthalmology visit to collect information on subsequent medical evaluation, newly identified systemic conditions, and changes in clinical management.
Read the detailed description
This is a multicenter, clinician-cluster randomized controlled study conducted in general ophthalmology clinics. Participating ophthalmologists will be assigned to either usual care or usual care with access to supplementary information generated by an artificial intelligence system. The system analyzes fundus photographs and other routinely acquired optical ophthalmic images and provides additional health-related information for physician reference.
The information provided by the AI system is intended only to support clinical judgment. It does not independently establish a diagnosis or prescribe specific investigations or treatments. Treating ophthalmologists will interpret the information together with the patient's history, ophthalmic findings, and their own clinical judgment. When considered appropriate, patients may be advised to seek further evaluation in another medical specialty. Subsequent investigations, diagnoses, and treatments will follow routine clinical practice. Participants will be followed after the ophthalmology visit to collect information on subsequent medical evaluation and clinical care. The study will assess whether access to the AI-assisted information is associated with differences in newly identified systemic conditions and subsequent clinical management.
- Conditions
- Systemic Health Risk
- Being tested
- AI-Assisted Health Risk Information
- Keywords
- Artificial Intelligence, Retinal Imaging, Ophthalmology, Clinical Decision Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Health Risk InformationOther
An artificial intelligence system analyzes routinely acquired ophthalmic images and provides supplementary information on possible systemic health risks to the ophthalmologist. The information may be considered together with other clinical information when making decisions about further medical evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants receive routine ophthalmic care according to usual clinical practice. |
| AI-Assisted Care | Experimental | Participants receive routine ophthalmic care. In addition, ophthalmologists have access to supplementary health risk information generated by an AI system from routinely acquired ophthalmic images. The information is intended only to support clinical judgment and does not independently establish a diagnosis or determine specific investigations or treatment. Receives: Other: AI-Assisted Health Risk Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
New systemic diagnosis or clinical management
Percentage of participants with at least one newly confirmed systemic disease diagnosis and/or new systemic clinical management documented after the index ophthalmology visit.
Measured: Within 90 days after the index ophthalmology visit
Secondary outcomes (2)
New systemic disease diagnosis
Percentage of participants with at least one newly confirmed systemic disease diagnosis documented during subsequent medical evaluation.
Measured: Within 90 days after the index ophthalmology visit
New systemic clinical management
Percentage of participants with at least one new systemic clinical management action, including initiation or modification of treatment, disease-specific follow-up, or other clinically indicated management.
Measured: Within 90 days after the index ophthalmology visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion19 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Health RiskStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating ophthalmologists are randomized in a 1:1 ratio to usual care or usual care with access to AI-assisted health risk information. Patients are enrolled according to the randomized group of their treating ophthalmologist.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Wei Wang, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890922
- Sponsor's protocol ID
- LifeEye-RCT-001
- Acronym
- LifeEye-RCT
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for public sharing because the study includes sensitive clinical and imaging data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of AI-Assisted Systemic Health Risk Assessment in General Ophthalmology: A Multicenter Pragmatic Clinician-Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07890922
- Acronym / sponsor ID
- LifeEye-RCT / LifeEye-RCT-001
- Conditions
- Systemic Health Risk
- Keywords
- Artificial Intelligence, Retinal Imaging, Ophthalmology, Clinical Decision Support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 19 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Oct 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 will evaluate whether providing ophthalmologists with additional artificial intelligence (AI)-assisted health risk information derived from routine retinal images affects subsequent clinical care in adults attending general ophthalmology clinics. Participating ophthalmologists will be assigned to either usual ophthalmic care or usual ophthalmic care with access to supplementary information generated by an AI system. The AI system does not independently diagnose disease or determine treatment. All clinical decisions remain the responsibility of the ophthalmologist. Participants will receive routine ophthalmic care and will be followed after the ophthalmology visit to collect information on subsequent medical evaluation, newly identified systemic conditions, and changes in clinical management.
Detailed description
This is a multicenter, clinician-cluster randomized controlled study conducted in general ophthalmology clinics. Participating ophthalmologists will be assigned to either usual care or usual care with access to supplementary information generated by an artificial intelligence system. The system analyzes fundus photographs and other routinely acquired optical ophthalmic images and provides additional health-related information for physician reference.
The information provided by the AI system is intended only to support clinical judgment. It does not independently establish a diagnosis or prescribe specific investigations or treatments. Treating ophthalmologists will interpret the information together with the patient's history, ophthalmic findings, and their own clinical judgment. When considered appropriate, patients may be advised to seek further evaluation in another medical specialty. Subsequent investigations, diagnoses, and treatments will follow routine clinical practice. Participants will be followed after the ophthalmology visit to collect information on subsequent medical evaluation and clinical care. The study will assess whether access to the AI-assisted information is associated with differences in newly identified systemic conditions and subsequent clinical management.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participating ophthalmologists are randomized in a 1:1 ratio to usual care or usual care with access to AI-assisted health risk information. Patients are enrolled according to the randomized group of their treating ophthalmologist.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants receive routine ophthalmic care according to usual clinical practice. |
| AI-Assisted Care | Experimental | Other: AI-Assisted Health Risk InformationParticipants receive routine ophthalmic care. In addition, ophthalmologists have access to supplementary health risk information generated by an AI system from routinely acquired ophthalmic images. The information is intended only to support clinical judgment and does not independently establish a diagnosis or determine specific investigations or treatment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40 years or older.
- Attending a participating general ophthalmology clinic for ophthalmic care.
- At least one routinely acquired ophthalmic image suitable for analysis is available.
- Able to provide informed consent.
- Able to participate in follow-up approximately 30 and 90 days after enrollment.
Key exclusion criteria (4 listed)
- Unable to provide informed consent.
- An ophthalmic or systemic medical emergency requiring immediate care.
- Available ophthalmic images are unsuitable for analysis.
- Previous enrollment in this study.
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 |
|---|---|---|
| AI-Assisted Health Risk InformationAn artificial intelligence system analyzes routinely acquired ophthalmic images and provides supplementary information on possible systemic health risks to the ophthalmologist. The information may be considered together with other clinical information when making decisions about further medical evaluation. | Other | AI-Assisted Care |
Primary outcome
New systemic diagnosis or clinical management
Time frame: Within 90 days after the index ophthalmology visit
Percentage of participants with at least one newly confirmed systemic disease diagnosis and/or new systemic clinical management documented after the index ophthalmology visit.
2 secondary outcomes
New systemic disease diagnosis
Time frame: Within 90 days after the index ophthalmology visit
New systemic clinical management
Time frame: Within 90 days after the index ophthalmology visit
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 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned for public sharing because the study includes sensitive clinical and imaging data.
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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.
Wei Wang, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen 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 AI-Assisted Health Risk Information in people with Systemic Health Risk, run by Zhongshan Ophthalmic Center, Sun Yat-sen 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 5 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 28 Oct 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 Wei Wang, PhD (86-20-87334687, wangwei@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New systemic diagnosis or clinical management (time frame: Within 90 days after the index ophthalmology visit). 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 28 Oct 2026.