A Study to Evaluate the Clinical Performance of VeriSee GLC for Screening of Glaucoma Suspect Using Color Fundus Images

NCT07550712 | Completed

• 1 other identifier: AMED2401
• Study Type: observational
• Target: 773
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the clinical performance of VeriSee GLC for identifying glaucoma suspects using color fundus images in adult participants. The main questions it aims to answer are:

• What are the sensitivity and specificity of VeriSee GLC for detecting glaucoma suspects based on fundus images?
• How does the performance of VeriSee GLC compare with the reference standard defined by the majority consensus of three independent evaluators? Researchers will compare the screening results generated by VeriSee GLC with the reference standard to assess its diagnostic performance. This retrospective study will use previously collected fundus images. VeriSee GLC performs automated image analysis to identify glaucomatous signs, including retinal nerve fiber layer (RNFL) defects, vertical cup-to-disc ratio (VCDR) enlargement, and rim-to-disc ratio (RDR) changes. The output is intended to assist healthcare professionals in identifying glaucoma suspects for referral, rather than providing a definitive diagnosis.

Conditions

Glaucoma

Keywords

Glaucoma suspect

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the VeriSee GLC for screening glaucoma suspects

  The primary outcome is the sensitivity and specificity of the VeriSee GLC in identifying glaucoma suspects based on color fundus images, compared against the reference standard defined by the majority consensus of three independent evaluators.

  1 Day

Secondary Outcomes (3)

• Positive predictive value (PPV), negative predictive value (NPV), and accuracy of VeriSee GLC for screening glaucoma suspects

  1 Day

• Accuracy of detection for 3 glaucomatous signs

  1 Day

• Dice coefficient of disc and cup contours

  1 Day

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of de-identified retrospective cases collected from National Taiwan University Hospital between February 1, 2022 and December 31, 2023. Cases were identified based on predefined ICD-10 code criteria, with exclusions applied for cataracts, acute angle-closure glaucoma, and prior ocular laser procedures. All cases were further screened according to predefined image inclusion and exclusion criteria, including image resolution, field of view, refractive status, and the visibility of the optic disc and retinal nerve fiber layer (RNFL), as determined by healthcare professionals. A total of 773 evaluable cases were included, of which 749 images were successfully analyzed by VeriSee GLC.

You may qualify if:

• The adult color fundus image (aged 20 and above)
• The requirements of color fundus image
• The resolution of image is 1024 × 1024 pixels or higher;
• The angle view of image is 45-or 50-degree.
• Images captured from eyes with myopia not exceeding -10 diopters.
• The color fundus image includes the optic disc and RNFL areas, and one of these areas is evaluable, as judged by the healthcare professionals.

You may not qualify if:

• The color fundus images previously used by VeriSee GLC during the development process and pre-clinical test.
• A color fundus image of patients with cataracts, acute angle closure glaucoma or those who have undergone retinal laser surgery.
• The optic disc and RNFL areas in the color fundus images is invisible to determine the disease condition as judged by the healthcare professionals.

Sponsors & Collaborators

• Acer Medical Inc.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 24, 2026
• Study Start: August 26, 2024
• Primary Completion: August 26, 2024
• Study Completion: December 27, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)