A Study to Evaluate the Clinical Performance of VeriSee GLC for Screening of Glaucoma Suspect Usi… (NCT07550712) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Clinical Performance of VeriSee GLC for Screening of Glaucoma Suspect Using Color Fundus Images
Taiwan773 participantsStarted 2024-08-26
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The adult color fundus image (aged 20 and above)
. The requirements of color fundus image
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity and Specificity of the VeriSee GLC for Screening Glaucoma Suspects