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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
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This study is to evaluate the clinical performance of VeriSee DR for DR screening from color fundus photography images in patients with diabetes mellitus. The sensitivity and specificity of VeriSee DR's automated image analysis for screening the diabetes retinopathy will be determined.
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN) | 2 months |
| Specificity | To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Values (PPV) | To evaluate the clinical performance of VeriSee DR by determining the positive predictive values (PPV). Positive predictive value (PPV) =100% x TP/(TP+FP) | 2 months |
| Negative Predictive Values (NPV) |
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Inclusion Criteria:
Subjects enrolled in this study should meet all the following criteria.
Subject with age ≥ 20 years old
Subject with documented diagnosis of diabetes mellitus
Subject with image taken by color fundus photography that meet the following requirement:
Subject's image includes macula and optic nerve as judged by the ophthalmologist.
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria.
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Persons with diabetes, twenty years of age or older, who have been referred to an ophthalmologists for a dilated eye examination to detect diabetic retinopathy.
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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 | A total of 703 subjects with at least one qualified color fundus photography image as determined by the ophthalmologist were enrolled in this study. All 703 subjects enrolled were included in the intended use population. A total of 703 qualified color fundus photography images from all enrolled subjects were included for effectiveness analysis. No subjects were excluded from the intended use population. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 30, 2019 | Jan 11, 2021 |
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To evaluate the clinical performance of VeriSee DR by determining the negative predictive values (NPV).
Negative predictive value (NPV) = 100% x TN/(FN+TN)
| 2 months |
| Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR | To determine the percentage of subjects' images with insufficient quality as judged by VeriSee DR. The percentage of subjects who have the images with insufficient quality as determined by VeriSee DR will be presented. | 2 months |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intended Use Population | Intended Use Population |
| 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 | Standard Deviation | 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 | No |
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| 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 DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN) | Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality. | Posted | Number | 95% Confidence Interval | percent | 2 months |
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| Primary | Specificity | To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP) | Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality. | Posted | Number | 95% Confidence Interval | percent | 2 months |
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| Secondary | Positive Predictive Values (PPV) | To evaluate the clinical performance of VeriSee DR by determining the positive predictive values (PPV). Positive predictive value (PPV) =100% x TP/(TP+FP) | Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality. | Posted | Number | 95% Confidence Interval | percent | 2 months |
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| Secondary | Negative Predictive Values (NPV) | To evaluate the clinical performance of VeriSee DR by determining the negative predictive values (NPV). Negative predictive value (NPV) = 100% x TN/(FN+TN) | Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality. | Posted | Number | 95% Confidence Interval | percent | 2 months |
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| Secondary | Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR | To determine the percentage of subjects' images with insufficient quality as judged by VeriSee DR. The percentage of subjects who have the images with insufficient quality as determined by VeriSee DR will be presented. | Posted | Count of Participants | Participants | 2 months |
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this study is a retrospective study so there is no need to collect adverse event data.
this study is a retrospective study so there is no need 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 | A total of 703 subjects with at least one qualified color fundus photography image as determined by the ophthalmologist were enrolled in this study. All 703 subjects enrolled were included in the intended use population. A total of 703 qualified color fundus photography images from all enrolled subjects were included for effectiveness analysis. No subjects were excluded from the intended use population. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulator Manager | Acer Healthcare Inc. | 886-6-26963131 | 5789 | Johnny.Lu@acer.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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