Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Study Overview
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Brief Summary
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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.

Official Title
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MEPEDS New Device Pediatric Vision Scanner

Conditions
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Amblyopia, Strabismus

Intervention / Treatment
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* Device: Pediatric Vision Scanner eye scan


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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 eye scan<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 eye scan<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 eye scan<br>* Subject is scanned with a 2.5 second pediatric vision scanner device test.<br>|

What is the study measuring?
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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 |