Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Pediatric Vision Scanner 4 (PVS4)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01832883

Enrollment

Registered

2013-04-16

Start date

2010-12-31

Completion date

2012-07-31

Last updated

2018-04-13

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

3 Years to 8 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Binocularity score	Day 1

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

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