Major Article
Validation of the Pediatric Vision Scanner in a normal preschool population

https://doi.org/10.1016/j.jaapos.2021.03.010Get rights and content

Purpose

To assess the Pediatric Vision Scanner (PVS), a handheld vision screening device designed to test for amblyopia and strabismus, in a general pediatric population.

Methods

In this prospective study, trained research staff screened 300 eligible children 24-72 months of age with no known eye conditions for amblyopia and strabismus using the PVS. A pediatric ophthalmologist masked to PVS screening results then performed a comprehensive eye examination. Sensitivity and specificity of the PVS was calculated with a 95% confidence interval.

Results

Based on the gold standard eye examination, 6 children (2%) had amblyopia and/or strabismus. The PVS detected all 6 cases, yielding a sensitivity rate of 100% (95% CI, 54%-100%). The PVS referred 45 additional children (15%) who had normal ophthalmic findings, yielding a specificity rate of 85% (95% CI, 80%-89%). The median acquisition time for the PVS was 28 seconds.

Conclusions

The PVS detected amblyopia with high sensitivity in a nonenriched pediatric population. The device would allow children with amblyopia and/or strabismus to be referred to an eye care specialist as early as 2 years old. Given its short acquisition time, the PVS can be implemented in a pediatric clinic with minimal impact on workflow.

Section snippets

Subjects and Methods

Kaiser Permanente Southern California (KPSC) Institutional Review Board approval was obtained for this study, which adhered to the tenets of the Declaration of Helsinki and was registered on ClinicalTrials.gov (NCT02536963).

Results

Of the 318 children enrolled in the study, 18 were excluded from analysis; we were unable to obtain reliable PVS results from 3 children due to device malfunction and from 8 children due to lack of cooperation. An additional 7 patients left the clinic before completing the eye examination. Of the 300 children included in the analysis, 141 were female (47%) and 149 were male (53%). The median age was 48 months. With regard to race, 121 participants (40.3%) were non-Hispanic white, 80 (26.7%)

Discussion

Screening preverbal children with instrument-based screening can be fraught with poor specificity, false positives, and unnecessary referrals.13 In a prior study examining the PVS in a similar primary care cohort, Jost and colleagues11 reported data for 100 children; however, they screened nearly 300 children, with only one-third presenting for follow-up examination. In their study, 1 patient who had amblyopia on examination was also detected on PVS screening. The small numbers in that study

References (18)

There are more references available in the full text version of this article.

Cited by (5)

Financial support: Rebiscan Inc. (dba Rebion), Boston, MA, and National Institutes of Health (National Eye Institute), Bethesda, MD (R44EY025926). The funding organizations had no role in the design or conduct of this research.

View full text