N/A
Completed N=986
Clinical Evaluation of VeriSee AMD in Screening for Age-Related Macular Degeneration
Macular Degeneration, Age Related · Maculopathy, Age Related
Source: ClinicalTrials.gov NCT05593913 ↗
Enrolled (actual)
986
Serious AEs
—
Results posted
Jan 2024
Primary outcomePrimary: Sensitivity — 90 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity |
90 | — |
| PRIMARY Specificity |
96.5 | — |
| SECONDARY Positive Predictive Values (PPV) |
87.9 | — |
| SECONDARY Negative Predictive Values (NPV) |
97.1 | — |
| SECONDARY The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD |
39 | — |
Eligibility Criteria
Inclusion Criteria
- Subject with age ≥ 50 years old
- Subject with image taken by color fundus photography that meet the following requirement:
- The resolution of image is 271x271 pixels or higher;
- 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.
Data sourced from ClinicalTrials.gov (NCT05593913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.