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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Sensitivity and Specificity of the VeriSee GLC for Screening Glaucoma Suspects

Time frame: 1 Day

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.

Secondary outcomes

Positive Predictive Value (PPV), Negative Predictive Value (NPV), and Accuracy of VeriSee GLC for Screening Glaucoma Suspects

Time frame: 1 Day

Evaluate the PPV, NPV, and overall accuracy of the VeriSee GLC in identifying glaucoma suspects relative to the reference standard.
Accuracy of Detection for 3 Glaucomatous Signs - VCDR and RDR

Time frame: 1 Day
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
Accuracy of Detection for 3 Glaucomatous Signs - RNFL Defect

Time frame: 1 Day
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
Dice Coefficient of Disc and Cup Contours

Time frame: 1 Day

Dice coefficient measures the similarity between contours generated by VeriSee GLC and evaluator annotations. The Dice coefficient ranges from 0 (no overlap) to 1 (perfect agreement).

Sponsors and collaborators

Lead sponsor

Acer Medical Inc.

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Apr 24, 2026
Registry last updated: Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed