Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
ID06843499

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

Led by National Taiwan University Hospital · Updated on 2025-06-22

1000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

F

Fu Jen Catholic University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of an artificial intelligence (AI)-assisted screening system called VeriSee in diagnosing common eye diseases, including age-related macular degeneration (AMD) and diabetic retinopathy (DR). The study aims to provide scientific evidence on how this AI system could improve the efficiency and accuracy of ophthalmic disease diagnosis and treatment by supporting ophthalmologists in clinical decisions. Participants will undergo fundus photography screening where the VeriSee AI-assisted diagnostic software analyzes the images to detect signs of AMD and DR. Ophthalmologists will also independently interpret the same images, and their findings will be compared with the AI's results. The VeriSee system is installed on a computer and uses advanced AI algorithms to assess image quality and disease conditions, providing instant diagnostic support in clinical settings. During the study, participants' fundus images and clinical data will be collected and analyzed. Researchers will measure the sensitivity, specificity, and agreement between AI-assisted screening and physician-confirmed diagnoses over about one month. Cost analysis including direct and indirect expenses will be evaluated up to 12 months after screening. The study spans from enrollment through follow-up, with the goal of improving early detection and management of these eye conditions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • The patient does not agree to participate in the trial or is unable to provide informed consent.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surveillance

Duration - Approximately 1 month

Participants undergo fundus photography screening using AI-assisted diagnostic software and ophthalmologists independently interpret the same images to compare results.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants' health and outcomes are monitored for up to 12 months following screening to assess cost-effectiveness and clinical outcomes.

Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, Taiwan, 100225

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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