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

NCT06843499 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-06-22

No results posted yet for this study

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.

Conditions

  • Age-Related Macular Degeneration (AMD)
  • Diabetic Retinopathy (DR)

Interventions

OTHER

The VeriSee AI-assisted diagnostic system

VeriSee AMD, VeriSee DR, and VeriSee GLC are AI-based medical software devices designed for screening age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, respectively. These systems utilize advanced AI algorithms to analyze color fundus photography images for disease assessment. By installing the software on a computer, the system can evaluate image quality, predict disease conditions, and instantly provide results to clinical physicians, serving as a diagnostic aid.

OTHER

Data collection from the patient's clinical history

Data collection from the patient's clinical history was conducted because the VeriSee AI-assisted diagnostic system was not used.

Sponsors & Collaborators

  • Fu Jen Catholic University Hospital

    collaborator OTHER

  • Min-Sheng General Hospital

    collaborator OTHER

  • Ministry of Health and Welfare, Taiwan

    collaborator OTHER_GOV

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06843499 on ClinicalTrials.gov