An interventional study of AI-Assisted Health Risk Information in Systemic Health Risk, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Screening
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.
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.
Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
Participants receive routine ophthalmic care according to usual clinical practice.
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.
Other: AI-Assisted Health Risk Information
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.
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.
Time frame: Within 90 days after the index ophthalmology visit
New systemic disease diagnosis
Percentage of participants with at least one newly confirmed systemic disease diagnosis documented during subsequent medical evaluation.
Time frame: 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.
Time frame: Within 90 days after the index ophthalmology visit
Plan to share: No — Individual participant data are not planned for public sharing because the study includes sensitive clinical and imaging data.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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