Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Completed

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

• Registration Number: NCT01726842
• 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-11-11
• Study First Posted: 2012-11-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States