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

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.

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.