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A Study to Evaluate the Clinical Performance of VeriSee GLC for Screening of Glaucoma Suspect Using Color Fundus Images
Sponsor: Acer Medical Inc.
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