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NCT07550712

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

Sponsor: Acer Medical Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

OBSERVATIONAL

Enrollment

773

Start Date

2024-08-26

Completion Date

2024-12-27

Last Updated

2026-06-25

Healthy Volunteers

Not specified

Conditions

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan