Submitted for Publication: October 2, 2013; final revision received December 19, 2013; accepted January 4, 2014.
Published Online: May 29, 2014. doi:10.1001/jamaophthalmol.2014.424.
Study concept and design: Birch.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Jost, Yanni.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Jost, Birch.
Obtained funding: Yanni, Birch.
Administrative, technical, or material support: Yanni, D. Stager, Dao.
Study supervision: Yanni, Birch.
Conflict of Interest Disclosures: None reported.
Funding/Support: This work was supported by grant 9491 from the Thrasher Research Fund and by grant EY022313 from the National Institutes of Health National Eye Institute.
Role of the Sponsors: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Previous Presentations: This study was presented, in part, at the annual meeting of the American Association for Pediatric Ophthalmology and Strabismus; April 6, 2013; Boston, Massachusetts, and annual meeting of the Association for Research in Vision and Ophthalmology; May 9, 2013; Seattle, Washington.
Additional Information: The US Food and Drug Administration determined that the Pediatric Vision Scanner has an Investigational Device Exemption under 21 CFR 812.2(b) for devices with a nonsignificant risk.