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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma

• Study Type: Observational
• Enrollment (Actual): 773

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

1. The adult color fundus image (aged 20 and above)

2. 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.
3. The color fundus image includes the optic disc and RNFL areas, and one of these areas is evaluable, as judged by the healthcare professionals.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value (PPV), negative predictive value (NPV), and accuracy of VeriSee GLC for screening glaucoma suspects	Evaluate the PPV, NPV, and overall accuracy of the VeriSee GLC in identifying glaucoma suspects relative to the reference standard.	1 Day
Accuracy of detection for 3 glaucomatous signs	Assess the accuracy of VeriSee GLC in detecting three glaucomatous signs: Vertical cup-to-disc ratio (VCDR ≥ 0.7); Rim-to-disc ratio (RDR ≤ 0.1); Retinal nerve fiber layer (RNFL) defect	1 Day
Dice coefficient of disc and cup contours	Measure the overlap (Dice coefficient) for the disc/cup contours between VeriSee GLC and the evaluators.	1 Day

Collaborators and Investigators

• Sponsor: Acer Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Actual): August 26, 2024
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Glaucoma suspect
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: AMED2401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to data privacy considerations and institutional policy restrictions.