Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Rebiscan, Inc.300 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

300

Conditions

Amblyopia Strabismus

Interventions

Pediatric Vision ScannerDEVICE

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Retina Foundation of the Southwest

Dallas, Texas, United States

Outcomes

Primary Outcomes

Binocularity score

Time frame: Day 1

Secondary Outcomes

Presence of amblyopia risk factors

Time frame: Day 1

Data from ClinicalTrials.gov

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