A novel device for assessment of amblyopic risk factors in preverbal and verbal children–a pilot study

Objectives: This paper evaluates the accuracy of the Eye-N-JOY (ENJ), a novel device (Patent no. US 9844317 B2), for identifying the presence of amblyopic risk factors. This device was developed to assess both visual acuity, ocular alignment, and eye movement; all while watching images on a tablet screen. Methods: A prospective, single-center, comparison study. Participants were examined by the ENJ first and then underwent a comprehensive full eye examination by pediatric ophthalmologists including cycloplegic refraction. Both the technician operating the ENJ and the physicians were masked to each other’s findings. Children aged 18–72 months (1.5 to 6 years) attending a tertiary medical center for a full standard pediatric ophthalmology examination were included. The visual acuity and alignment were compared between the ENJ and the gold standard full ophthalmologic examination. The differences were noted, and the sensitivity and specificity were calculated. Results: A total of 51 children were enrolled, 33 (64.7%) girls, aged 18–72 months. All children successfully completed the examination by the ENJ. No significant difference between the ENJ and the reference examination was detected in visual acuity measurements in both eyes (Pv = 0.553 for the right eye and 0.803 for the left). Overall agreement between all referral indications between the ENJ and reference examination was 84.3%, with 90.9% agreement in VA referral criteria and 90.1% in alignment referral criteria. Conclusions: Eye-N-Joy can reliably examine both visual acuity and ocular misalignment in verbal and pre-verbal children.