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Real-World Randomized Controlled Trial on the Use of a Visual Language Foundation Model to Assist in the Diagnosis of Eye Diseases

Real-World Randomized Controlled Trial on the Use of a Visual Language Foundation Model to Assist in the Diagnosis of Eye Diseases

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090964
Enrollment
Unknown
Registered
2024-10-16
Start date
2024-05-16
Completion date
Unknown
Last updated
2024-10-21

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 basic information and fundus photography of patients
Intervention group:Conduct fundus screening with EyeFM assistance, provide eye disease diagnosis and report writing based on the results of basic information and fundus photography of patientsfundus i

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 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.

Design outcomes

Primary

MeasureTime frame
Correct diagnosis rate;Correct referral rate;

Secondary

MeasureTime frame
Grading of consultation report;Patient compliance for referral and examination;Patient compliance for treatment and self-management;Satisfaction;

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