Macular Degeneration, Age Related, Maculopathy, Age Related
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Taiwan University Hospital
Acer Medical Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with age ≥ 50 years old * Subject with image taken by color fundus photography that meet the following requirement: 1. The resolution of image is 271x271 pixels or higher; 2. The angle view of image is 45 or 50 degree. * Subject's image includes macula as judged by the ophthalmologist.
Exclusion criteria
* The color fundus photography image previously used by VeriSee AMD during the development process and pre-clinical test * The macula 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 | 1 day | To evaluate the clinical performance of VeriSee AMD by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN) |
| Specificity | 1 day | To evaluate the clinical performance of VeriSee AMD by determining the Specificity. Specificity = 100% x TN/(TN+FP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Values (PPV) | 1 day | To evaluate the clinical performance of VeriSee AMD by determining the positive predictive values (PPV). Positive predictive value (PPV) =100% x TP/(TP+FP) |
| Negative Predictive Values (NPV) | 1 day | To evaluate the clinical performance of VeriSee AMD by determining the negative predictive values (NPV). Negative predictive value (NPV) = 100% x TN/(FN+TN) |
| The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD | 1 day | The percentage of the images with insufficient quality as determined by VeriSee AMD will be presented. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 986 |
| Total | 986 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insufficient image quality | 39 |
Baseline characteristics
| Characteristic | Test Group | — |
|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 11.23 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Taiwan | 986 Participants | — |
| Sex: Female, Male Female | 403 Participants | — |
| Sex: Female, Male Male | 583 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 AMD by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)
Time frame: 1 day
Population: Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Sensitivity | 90 percent |
Primary
Specificity
To evaluate the clinical performance of VeriSee AMD by determining the Specificity. Specificity = 100% x TN/(TN+FP)
Time frame: 1 day
Population: Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as insufficient image quality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Specificity | 96.5 percent |
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)
Time frame: 1 day
Population: Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Negative Predictive Values (NPV) | 97.1 percent |
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)
Time frame: 1 day
Population: Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Positive Predictive Values (PPV) | 87.9 percent |
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.
Time frame: 1 day
Population: The enrolled subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group | The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD | 39 Participants |