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

An observational study of Glaucoma, run by Acer Medical Inc. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Glaucoma
How many people: 773 participants
Where: 1 siteTaiwan
Study dates: 26 Aug 2024to 27 Dec 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Adult, Older adult

Study population: The study population consisted of de-identified retrospective cases collected from National Taiwan University Hospital between February 1, 2022 and December 31, 2023. Cases were identified based on predefined ICD-10 code criteria, with exclusions applied for cataracts, acute angle-closure glaucoma, and prior ocular laser procedures. All cases were further screened according to predefined image inclusion and exclusion criteria, including image resolution, field of view, refractive status, and the visibility of the optic disc and retinal nerve fiber layer (RNFL), as determined by healthcare professionals. A total of 773 evaluable cases were included, of which 749 images were successfully analyzed by VeriSee GLC.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University Hospital
Taipei, 100

Other trials in Taiwan

About this study

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.

Conditions: Glaucoma
Keywords: Glaucoma suspect
Medical subject headings: Glaucoma, Ocular Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity and Specificity of the VeriSee GLC for Screening Glaucoma Suspects
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.
Measured: 1 Day

Secondary outcomes (4)

Positive Predictive Value (PPV), Negative Predictive Value (NPV), and Accuracy of VeriSee GLC for Screening Glaucoma Suspects
Evaluate the PPV, NPV, and overall accuracy of the VeriSee GLC in identifying glaucoma suspects relative to the reference standard.
Measured: 1 Day
Accuracy of Detection for 3 Glaucomatous Signs - VCDR and RDR
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
Measured: 1 Day
Accuracy of Detection for 3 Glaucomatous Signs - RNFL Defect
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
Measured: 1 Day
Dice Coefficient of Disc and Cup Contours
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).
Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 202427 Dec 2024

First posted24 Apr 2026
Study start26 Aug 2024
Primary completion26 Aug 2024
Study completion27 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 773 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07550712
Sponsor's protocol ID: AMED2401
Status last verified: Apr 2026
First submitted: 10 Apr 2026
Last updated: 25 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Individual participant data (IPD) will not be shared due to data privacy considerations and institutional policy restrictions.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Clinical Performance of VeriSee GLC for Screening of Glaucoma Suspect Using Color Fundus Images
ClinicalTrials.gov ID: NCT07550712
Acronym / sponsor ID: AMED2401
Conditions: Glaucoma
Keywords: Glaucoma suspect
Study type: Observational
Recruitment status: Completed
Enrolment: 773 participants (actual)
Lead sponsor: Acer Medical Inc.Industry (pharma, biotech, devices)
Study start: 26 Aug 2024 (actual)
Primary completion: 26 Aug 2024 (actual)
Study completion: 27 Dec 2024 (actual)
First posted: 24 Apr 2026 (actual)
Results: Posted 25 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 20 years and older
Sex: All
Age groups: Adult, Older adult
Study population: The study population consisted of de-identified retrospective cases collected from National Taiwan University Hospital between February 1, 2022 and December 31, 2023. Cases were identified based on predefined ICD-10 code criteria, with exclusions applied for cataracts, acute angle-closure glaucoma, and prior ocular laser procedures. All cases were further screened according to predefined image inclusion and exclusion criteria, including image resolution, field of view, refractive status, and the visibility of the optic disc and retinal nerve fiber layer (RNFL), as determined by healthcare professionals. A total of 773 evaluable cases were included, of which 749 images were successfully analyzed by VeriSee GLC.

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

4 secondary outcomes

Positive Predictive Value (PPV), Negative Predictive Value (NPV), and Accuracy of VeriSee GLC for Screening Glaucoma Suspects
Time frame: 1 Day
Accuracy of Detection for 3 Glaucomatous Signs - VCDR and RDR
Time frame: 1 Day
Accuracy of Detection for 3 Glaucomatous Signs - RNFL Defect
Time frame: 1 Day
Dice Coefficient of Disc and Cup Contours
Time frame: 1 Day

Results and safety

Results posted to the registry on 25 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Group	773	749

Primary outcome: Sensitivity and Specificity of the VeriSee GLC for Screening Glaucoma Suspects

Time frame: 1 Day. Number (95% Confidence Interval). Unit: percent

Measure	Test Group n = 749
Sensitivity	90.3 (86.8 to 93.8)
Specificity	82.1 (78.7 to 85.8)

Population analysed: Of the 773 included cases, 24 were excluded from the analysis due to insufficient image quality or insufficient clinical information.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: This is a retrospective study and it is not necessary to collect adverse event data.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Group	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to data privacy considerations and institutional policy restrictions.

Related trials for Glaucoma

Recruiting
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Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Acer Medical Inc. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of the VeriSee GLC for Screening Glaucoma Suspects (time frame: 1 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550712.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.