Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

Amblyopia Clinical Trial

Official title:

MEPEDS New Device Pediatric Vision Scanner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706991
• Other study ID #: rebiscan-003
• Status: Completed
• Phase: N/A
• First received: October 5, 2012
• Last updated: October 12, 2012
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: October 2012
• 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. All tests and observations will be done at a single visit over the course of approximately 30 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amblyopia
• Strabismus

Intervention

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

Locations

Country	Name	City	State
United States	Doheny Eye Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Rebiscan, Inc.	University of Southern California

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