Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Study Overview
=================
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.

Official Title
-----------------
Pediatric Vision Scanner for the Eradication of Amblyopia

Conditions
-----------------
Amblyopia, Strabismus

Intervention / Treatment
-----------------
* Device: Pediatric Vision Scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: 2-6 years old complete ophthalmic examination including cycloplegic refraction conducted on the same day or within 3 months strabismic, anisometropic, or normal (normal eye examination and refractive error according to AAPOS guidelines) parent provides informed consent Exclusion: other ocular disease (includes media opacities, anomalous optic nerve, ptosis, lid hemangioma, conjunctivitis, blepharitis, symptomatic NLD) or systemic disease (JIA, JRA, neurofibromatosis) developmental delay strabismus surgery in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Controls<br>Structurally normal eye with equal visual acuity and normal stereopsis. | Device: Pediatric Vision Scanner<br>* Subject is scanned with a 2.5 second pediatric vision scanner device test.<br>|
| Referral required<br>Diagnosed with amblyopia or constant strabismus, categorized based on the GSE. Amblyopia: VA <20/40 and 2 logMAR lines difference in normal eye Mild amblyopia (>20/40) Moderate amblyopia (20/40 and <20/100) Severe amblyopia (≥20/100 or worse) Bilateral amblyopia: >4 years age VA<20/40 OU including high hyperopia or high astigmatism. Strabismus: Constant: >2 PD at near and or distance. Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position. Amblyogenic factor categorization: 'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes. 'hypermetropia' (≥3.5 D), 'myopia' (≥-4.0 D), 'astigmatism' (≥1.5 D). 'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse. | Device: Pediatric Vision Scanner<br>* Subject is scanned with a 2.5 second pediatric vision scanner device test.<br>|
| Borderline<br>(no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis. | Device: Pediatric Vision Scanner<br>* Subject is scanned with a 2.5 second pediatric vision scanner device test.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocularity score |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of amblyopia risk factors |  | Day 1 |