Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Rebiscan, Inc.78 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Amblyopia Strabismus

Interventions

Pediatric Vision ScannerDEVICE

Subject is scanned with a 2.5 second pediatric vision scanner device test.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged 3-8 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)

Locations (1)

Vanderbilt Eye Institute

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Binocularity score

Time frame: Day 1

Secondary Outcomes

Presence of amblyopia risk factors

'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.

Time frame: Day 1

Data from ClinicalTrials.gov

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