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NCT07890922
AI-Assisted Systemic Health Risk Assessment in General Ophthalmology: A Cluster Randomized Trial
Conditions: Systemic Health Risk
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 2000
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Location: Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07890922). StuddyBuddy aggregates publicly available trial information.