Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Amblyopia Clinical Trial

Official title:

Pediatric Vision Scanner 4 (PVS4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832883
• Other study ID #: rebiscan-002
• Status: Completed
• First received: October 5, 2012
• Last updated: April 11, 2018
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: April 2018
• Source: Rebiscan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

• Amblyopia
• Strabismus

Intervention

Device:
• Pediatric Vision Scanner
Subject is scanned with a 2.5 second pediatric vision scanner device test.

Locations

Country	Name	City	State
United States	Vanderbilt Eye Institute	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Rebiscan, Inc.	Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocularity score		Day 1
Secondary	Presence of amblyopia risk factors	'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.	Day 1