AI-Assisted Systemic Health Risk Assessment in General Ophthalmology

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• New systemic diagnosis or clinical management — 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.

Trial sites (1)

More Zhongshan Ophthalmic Center, Sun Yat-sen University trials in China