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Recruiting NCT06843499

NCT06843499 Effectiveness and Cost-Effectiveness Evaluations of AI-Assisted Diagnostic Software (VeriSee) for Ophthalmic Disease Screening

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Clinical Trial Summary
NCT ID NCT06843499
Status Recruiting
Phase
Sponsor National Taiwan University Hospital
Condition Age-Related Macular Degeneration (AMD)
Study Type INTERVENTIONAL
Enrollment 1,000 participants
Start Date 2025-06-02
Primary Completion 2027-12-31

Trial Parameters

Condition Age-Related Macular Degeneration (AMD)
Sponsor National Taiwan University Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 20 Years
Max Age N/A
Start Date 2025-06-02
Completion 2027-12-31
Interventions
The VeriSee AI-assisted diagnostic systemData collection from the patient's clinical history

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Brief Summary

This study aims to evaluate the effectiveness of an artificial intelligence (AI)-assisted screening system in ophthalmic diagnosis. Using AI-based fundus photography, the system will assist physicians in diagnosing three common eye diseases: age-related macular degeneration and diabetic retinopathy (DR). The AI system will analyze fundus images from participants and rapidly generate detection results for ophthalmologists' reference in making final diagnoses and clinical decisions. The study will assess the clinical benefits of the AI-assisted diagnostic system, providing scientific evidence to enhance the efficiency of ophthalmic disease diagnosis and treatment.

Eligibility Criteria

Inclusion Criteria: * VeriSee AMD is used in non-retinal subspecialty ophthalmology clinics for adults aged 50 and above. * VeriSee DR is used in non-retinal subspecialty clinics for diabetic patients aged 20 and above. Exclusion Criteria: * The patient does not agree to participate in the trial or is unable to provide informed consent.

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