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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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Day |
| Accuracy of Detection for 3 Glaucomatous Signs - VCDR and RDR |
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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:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
Individual participant data (IPD) will not be shared due to data privacy considerations and institutional policy restrictions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group | The 773 cases from the intended use population, having one qualified color fundus images determined by the ophthalmologist, were enrolled in this study. A total of 773 color fundus images from all enrolled cases were included for effectiveness analysis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intended use population
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group | The 773 cases from the intended use population, having one qualified color fundus images determined by the ophthalmologist, were enrolled in this study. A total of 773 color fundus images from all enrolled cases were included for effectiveness analysis. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 773 included cases, 24 were excluded from the analysis due to insufficient image quality or insufficient clinical information. | Posted | Number | 95% Confidence Interval | percent | 1 Day |
|
This is a retrospective study and it is not necessary to collect adverse event data.
This is a retrospective study and it is not necessary to collect adverse event data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Group | The 773 cases from the intended use population, having one qualified color fundus images determined by the ophthalmologist, were enrolled in this study. A total of 773 color fundus images from all enrolled cases were included for effectiveness analysis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Regulatory Affairs & Quality Assurance | Acer Medical Inc. | +886-2-2696-0366 | 5778 | Shin.S.Teng@acer-medical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2024 | Apr 30, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Assess the accuracy of VeriSee GLC in detecting three glaucomatous signs:
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| 1 Day |
| Accuracy of Detection for 3 Glaucomatous Signs - RNFL Defect | Assess the accuracy of VeriSee GLC in detecting three glaucomatous signs:
| 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). | 1 Day |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Spherical Equivalent | Spherical Equivalent was calculated as the spherical refractive error plus one-half of the cylindrical refractive error. | Mean | Standard Deviation | Diopter (D) |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | 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. | Of the 773 included cases, 24 were excluded from the analysis due to insufficient image quality or insufficient clinical information. | Posted | Number | 95% Confidence Interval | percent | 1 Day |
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| Secondary | Accuracy of Detection for 3 Glaucomatous Signs - VCDR and RDR | Assess the accuracy of VeriSee GLC in detecting three glaucomatous signs:
| Of the 749 evaluable images, 733 images were of legible quality in the optic disc area, and 737 images were of legible quality in the RNFL area. | Posted | Number | 95% Confidence Interval | percent | 1 Day |
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| Secondary | Accuracy of Detection for 3 Glaucomatous Signs - RNFL Defect | Assess the accuracy of VeriSee GLC in detecting three glaucomatous signs:
| Of the 749 evaluable images, 733 images were of legible quality in the optic disc area, and 737 images were of legible quality in the RNFL area. | Posted | Number | 95% Confidence Interval | percent | 1 Day |
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| Secondary | 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). | Of the 773 included cases, 24 were excluded from the analysis due to insufficient image quality or insufficient clinical information. | Posted | Mean | 95% Confidence Interval | unitless | 1 Day |
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