Amblyopia, Strabismus
Conditions
Brief summary
The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus. All tests and observations will be done at a single visit over the course of approximately 30 minutes.
Interventions
Subject is scanned with a 2.5 second pediatric vision scanner device test.
Sponsors
Study design
Eligibility
Inclusion criteria
* Children aged 6 months to 6 years * Signed Informed consent by parent or guardian * Meet all inclusion criteria.
Exclusion criteria
* Children with a history of developmental delay or cognitive deficit * Children unable to complete the GSE (including visual acuity testing)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocularity score | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Presence of amblyopia risk factors | Day 1 |
Countries
United States