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

June 17, 2025 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Artificial Intelligence (AI) has shown significant potential in medical imaging analysis and disease diagnosis, particularly in ophthalmology. Substantial advancements have been made in utilizing AI for diagnosing common ophthalmic diseases, enhancing early detection and improving patient outcomes. Early diagnosis of age-related macular degeneration (AMD) and diabetic retinopathy (DR) is crucial for effective treatment and disease management.

However, current clinical diagnoses rely heavily on ophthalmologists, leading to challenges such as low patient attendance rates and unequal distribution of diagnostic resources. To address these issues, this study will provide robust evidence to further validate the diagnostic performance of AI-assisted screening and clinical effectiveness of the VeriSee AI-assisted diagnostic system in the detection of diabetic DR and AMD.

VeriSee AMD and VeriSee DR are AI-powered medical software tools designed to screen for AMD and DR, respectively. These systems employ advanced AI algorithms to analyze color fundus photography images, assess disease conditions, and evaluate image quality. By integrating this software into clinical workflows, physicians receive instant diagnostic support, improving efficiency and accessibility in ophthalmic disease screening.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Yi-Ting Hsieh, Medical Doctor
          • Phone Number: +886-2-2312-3456 ext. 265018
          • Email: ythyth@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AI Intervention
Patients will undergo fundus photography screening using artificial intelligence-assisted diagnostic software (VeriSee). Ophthalmologists will independently interpret the same images, and the results will be compared with those generated by the AI.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
The sensitivity of the index test (VeriSee) was calculated as the proportion of participants with reference standard-confirmed disease who were correctly identified as positive by the AI-assisted diagnostic software.
From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
Specificity
Time Frame: From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
The specificity of the index test was calculated as the proportion of participants without the target condition, as determined by the reference standard, who were correctly classified as negative by the AI-assisted diagnostic tool.
From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
Concordance
Time Frame: From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
Concordance between the AI-assisted diagnosis and the ophthalmologists' interpretation was assessed using the overall agreement rate (i.e., the percentage of cases with identical classification results).
From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cost Analysis (Including Direct and Indirect Costs)
Time Frame: From enrollment to 12 months after screening
This measure includes direct medical costs (e.g., screening, follow-up, medication, and treatment), healthcare-related indirect medical costs (e.g., IT system maintenance, healthcare personnel), and non-medical indirect costs (e.g., transportation and productivity loss due to blindness). Costs will be analyzed from both the National Health Insurance perspective and the broader societal perspective.
From enrollment to 12 months after screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Min-Sheng General Hospital
Ministry of Health and Welfare, Taiwan
Fu Jen Catholic University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202412086DINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-Related Macular Degeneration (AMD)

Clinical Trials on The VeriSee AI-assisted diagnostic system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe