Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Pediatric Vision Scanner for the Eradication of Amblyopia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01726842

Enrollment

300

Registered

2012-11-15

Start date

2010-10-31

Completion date

2012-12-31

Last updated

2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia, Strabismus

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.

Interventions

DEVICEPediatric Vision Scanner

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Binocularity score	Day 1

Secondary

Measure	Time frame
Presence of amblyopia risk factors	Day 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026