Diabetic Retinopathy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
National Taiwan University Hospital
Acer Being Health Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects enrolled in this study should meet all the following criteria. 1. Subject with age ≥ 20 years old 2. Subject with documented diagnosis of diabetes mellitus 3. Subject with image taken by color fundus photography that meet the following requirement: * The resolution of image is 1024×1024 pixels or higher; * The angle view of image is 45 or 50 degree. 4. 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. 1. The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test 2. The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 2 months | To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN) |
| Specificity | 2 months | To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Values (PPV) | 2 months | To evaluate the clinical performance of VeriSee DR by determining the positive predictive values (PPV). Positive predictive value (PPV) =100% x TP/(TP+FP) |
| Negative Predictive Values (NPV) | 2 months | To evaluate the clinical performance of VeriSee DR by determining the negative predictive values (NPV). Negative predictive value (NPV) = 100% x TN/(FN+TN) |
| Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR | 2 months | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Use Population Intended Use Population | 703 |
| Total | 703 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | poor image quality | 28 |
Baseline characteristics
| Characteristic | Intended Use Population | — |
|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 13.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Taiwan | 703 Participants | — |
| Sex: Female, Male Female | 354 Participants | — |
| Sex: Female, Male Male | 349 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Sensitivity
To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)
Time frame: 2 months
Population: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Use Population | Sensitivity | 95 percent |
Primary
Specificity
To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP)
Time frame: 2 months
Population: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Use Population | Specificity | 89.9 percent |
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)
Time frame: 2 months
Population: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Use Population | Negative Predictive Values (NPV) | 90.7 percent |
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.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intended Use Population | Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR | 28 Participants |
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)
Time frame: 2 months
Population: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Use Population | Positive Predictive Values (PPV) | 94.5 percent |