Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Completed

• Conditions: Amblyopia; Strabismus
• Interventions: Device: Pediatric Vision Scanner eye scan

• Registration Number: NCT01706991
• Lead Sponsor: Rebiscan, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-10
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-12
• Last Update Submitted: 2012-10-12
• Study First Posted: 2012-10-15
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Controls	Pediatric Vision Scanner eye scan	Structurally normal eye with equal visual acuity and normal stereopsis.
Referral required	Pediatric Vision Scanner eye scan	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.
Borderline	Pediatric Vision Scanner eye scan	(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.

Primary Outcome Measures

Name	Time	Method
Binocularity score	Day 1

Secondary Outcome Measures

Name	Time	Method
Presence of amblyopia risk factors	Day 1

Trial Locations

Locations (1)

Doheny Eye Institute; 🇺🇸 Los Angeles, California, United States