Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Normal Controls Structurally normal eye with equal visual acuity and normal stereopsis. |
Device: Pediatric Vision Scanner
Subject is scanned with a 2.5 second pediatric vision scanner device test.
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Referral required 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
Subject is scanned with a 2.5 second pediatric vision scanner device test.
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Borderline (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
Subject is scanned with a 2.5 second pediatric vision scanner device test.
|
Outcome Measures
Primary Outcome Measures
- Binocularity score [Day 1]
Secondary Outcome Measures
- Presence of amblyopia risk factors [Day 1]
'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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children aged 3-8 years
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Signed Informed consent by parent or guardian
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Meet all inclusion criteria.
Exclusion Criteria:
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Children with a history of developmental delay or cognitive deficit
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Children unable to complete the GSE (including visual acuity testing)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Vanderbilt Eye Institute | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Rebiscan, Inc.
- Vanderbilt University
Investigators
- Principal Investigator: Sean Donahue, MD, PhD, Vanderbilt Eye Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- rebiscan-002