Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Rebiscan

Status: Completed

Conditions: Strabismus; Amblyopia

Treatments: Device: Pediatric Vision Scanner

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01726842

rebiscan-001

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.

Enrollment: 300 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

300 participants in 3 patient groups

Normal Controls

Description:

Structurally normal eye with equal visual acuity and normal stereopsis.

Treatment:

Device: Pediatric Vision Scanner

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

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