Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Amblyopia Clinical Trial

Official title:

Pediatric Vision Scanner for the Eradication of Amblyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726842
• Other study ID #: rebiscan-001
• Status: Completed
• Phase: N/A
• First received: October 5, 2012
• Last updated: October 27, 2015
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: Rebiscan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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: 300
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

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	Retina Foundation of the Southwest	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Rebiscan, Inc.	Retina Foundation of the Southwest

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	Yes
Secondary	Presence of amblyopia risk factors		Day 1	Yes