Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Rebiscan

Status: Completed

Conditions: Strabismus; Amblyopia

Treatments: Device: Pediatric Vision Scanner eye scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01706991

rebiscan-003

Details and patient eligibility

About

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. All tests and observations will be done at a single visit over the course of approximately 30 minutes.

Enrollment: 32 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children aged 6 months to 6 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)

Trial design

32 participants in 3 patient groups

Normal Controls

Description:

Structurally normal eye with equal visual acuity and normal stereopsis.

Treatment:

Device: Pediatric Vision Scanner eye scan

Referral required

Description:

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.

Treatment:

Device: Pediatric Vision Scanner eye scan

Borderline

Description:

(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.

Treatment:

Device: Pediatric Vision Scanner eye scan