New pediatric vision screener, part II: electronics, software, signal processing and validation

Background: We have developed an improved pediatric vision screener (PVS) that can reliably detect central fixation, eye alignment and focus. The instrument identifies risk factors for amblyopia, namely eye misalignment and defocus. Methods: The device uses the birefringence of the human fovea (the most sensitive part of the retina). The optics have been reported in more detail previously. The present article focuses on the electronics and the analysis algorithms used. The objective of this study was to optimize the analog design, data acquisition, noise suppression techniques, the classification algorithms and the decision making thresholds, as well as to validate the performance of the research instrument on an initial group of young test subjects-18 patients with known vision abnormalities (eight male and 10 female), ages 4-25 (only one above 18) and 19 controls with proven lack of vision issues. Four statistical methods were used to derive decision making thresholds that would best separate patients with abnormalities from controls. Sensitivity and specificity were calculated for each method, and the most suitable one was selected. Results: Both the central fixation and the focus detection criteria worked robustly and allowed reliable separation between normal test subjects and symptomatic subjects. The sensitivity of the instrument was 100 % for both central fixation and focus detection. The specificity was 100 % for central fixation and 89.5 % for focus detection. The overall sensitivity was 100 % and the overall specificity was 94.7 %. Conclusions: Despite the relatively small initial sample size, we believe that the PVS instrument design, the analysis methods employed, and the device as a whole, will prove valuable for mass screening of children.