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A Randomized Controlled Trial for the Diagnosis and Management of Common Eye Diseases with Vision-Language Multi-modal Foundation Model Copilot

A Randomized Controlled Trial for the Diagnosis and Management of Common Eye Diseases with Vision-Language Multi-modal Foundation Model Copilot

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095518
Enrollment
Unknown
Registered
2025-01-08
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major eye diseases (diabetic retinopathy, glaucoma, age-related macular degeneration, myopic macular degeneration, macular hole, epiretinal membrane)

Interventions

Control group:Conduct routine fundus screening, provide eye disease diagnosis and report writing based on the results of text-based basic information and major complains and fundus photography of pati
Intervention group:Conduct fundus screening by ophthalmologist with EyeFM copilot, provide eye disease diagnosis and report writing based on the results of text-based basic information and major compl

Sponsors

Shanghai Health and Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age 50 or above and with high-risk systemic factors (including self-reported history of hypertension, diabetes, hyperlipidemia), or with high myopia regardless of age; (2) Have gradable color fundus photo (CFP); (3) Have not been previously diagnosed or treated for fundus diseases.

Exclusion criteria

Exclusion criteria: (1) Patients with urgent ocular complain; (2) Any situation that the researcher believes may endanger the safety of the subjects. (3) Those who have a history of drug abuse; (4) Those with infectious diseases which are at active phase

Design outcomes

Primary

MeasureTime frame
Correct diagnosis rate;Correct referral rate;

Secondary

MeasureTime frame
Grading of consultation report;Patient compliance with referral and examination;Patient compliance for treatment and self-management;Patient satisfaction with the experience;

Countries

China

Contacts

Public ContactTingli Chen

Shanghai Health and Medical Center

chentingli1028@163.com+86 139 5157 1028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026