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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
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An observational study is designed to evaluate the clinical performance of VeriSee AMD for potential age-related macular degeneration (AMD) screening from color fundus photography images. The sensitivity and specificity of VeriSee AMD's automated image analysis for screening AMD will be determined through the comparison with the gold standard, which is the judgment of AMD by the ophthalmologists.
This is a retrospective, single-center, observational study to assess the clinical performance of VeriSee AMD in screening for potential age-related macular degeneration (AMD).
Potential subjects with images of color fundus photography will be selected for eligibility, and then the ophthalmologist further confirms the images with legible quality. Three independent ophthalmologists (or evaluators) having more than 6 years of experience in retina will evaluate AMD from the color fundus photography images with different sequences of images independently. These three evaluators are different from the ophthalmologist who is responsible for deciding subject's eligibility. The evaluators determine the severity of AMD based on the four-level scale which is the AMD Severity Scale stated in Age-Related Eye Disease Study (AREDS) Report No. 6. Before the study, the training section is necessary to ensure the consensus of the AMD severity grading among three evaluators. The severity determined by the majority of the grade the three evaluators gave is considered the gold/reference standard in this study. Therefore, level 1 and level 2 are classified as non-mtl3AMD, while level 3 and advanced AMD (level 4) are classified as mtl3AMD. The clinical performance displayed as sensitivity and specificity will be determined by comparing the AMD results between VeriSee AMD and the gold standard.
VeriSee AMD is intended to screen AMD from the images taken by color fundus photography, which can assist the physicians to assess whether further examination for retinopathy by the ophthalmologist is needed. The screening result of AMD will be non-mtl3AMD or mtl3AMD for the physicians' reference and does not intend to diagnose AMD, detect concomitant diseases, or treat AMD.
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | To evaluate the clinical performance of VeriSee AMD by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN) | 1 day |
| Specificity | To evaluate the clinical performance of VeriSee AMD by determining the Specificity. Specificity = 100% x TN/(TN+FP) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Values (PPV) | To evaluate the clinical performance of VeriSee AMD by determining the positive predictive values (PPV). Positive predictive value (PPV) =100% x TP/(TP+FP) | 1 day |
| Negative Predictive Values (NPV) |
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Inclusion Criteria:
Subject with age ≥ 50 years old
Subject with image taken by color fundus photography that meet the following requirement:
Subject's image includes macula as judged by the ophthalmologist.
Exclusion Criteria:
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People fifty years of age or older have color fundus photography images.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group | The 986 subjects from the intended population, having at least one qualified color fundus photography image determined by the ophthalmologist, were enrolled in this study. A total of 986 color fundus photography images from all enrolled subjects were in use 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 986 subjects from the intended patient population, having at least one qualified color fundus photography image determined by the ophthalmologist, enrolled in this study. A total of 986 color fundus photography images from all enrolled subjects were in use 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 | To evaluate the clinical performance of VeriSee AMD by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN) | Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality. | Posted | Number | 95% Confidence Interval | percent | 1 day |
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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 986 subjects from the intended population, having at least one qualified color fundus photography image determined by the ophthalmologist, were enrolled in this study. A total of 986 color fundus photography images from all enrolled subjects were in use for effectiveness analysis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulator Manager | Acer Medical Inc. | 886-2-26960366 | AcerMedicalofficial@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2021 | Oct 26, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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To evaluate the clinical performance of VeriSee AMD by determining the negative predictive values (NPV).
Negative predictive value (NPV) = 100% x TN/(FN+TN)
| 1 day |
| The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD | The percentage of the images with insufficient quality as determined by VeriSee AMD will be presented. | 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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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Specificity | To evaluate the clinical performance of VeriSee AMD by determining the Specificity. Specificity = 100% x TN/(TN+FP) | Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as insufficient image quality. | Posted | Number | 95% Confidence Interval | percent | 1 day |
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| Secondary | Positive Predictive Values (PPV) | To evaluate the clinical performance of VeriSee AMD by determining the positive predictive values (PPV). Positive predictive value (PPV) =100% x TP/(TP+FP) | Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality. | Posted | Number | 95% Confidence Interval | percent | 1 day |
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| Secondary | Negative Predictive Values (NPV) | To evaluate the clinical performance of VeriSee AMD by determining the negative predictive values (NPV). Negative predictive value (NPV) = 100% x TN/(FN+TN) | Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality. | Posted | Number | 95% Confidence Interval | percent | 1 day |
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| Secondary | The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD | The percentage of the images with insufficient quality as determined by VeriSee AMD will be presented. | The enrolled subjects | Posted | Count of Participants | Participants | 1 day |
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