Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Completed

• Conditions: Amblyopia; Strabismus

• Registration Number: NCT01832883
• 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: 2010-12
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-16
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Binocularity score	Day 1

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vanderbilt Eye Institute; 🇺🇸 Nashville, Tennessee, United States