Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare

Autism spectrum disorder (ASD) is a developmental condition that can affect communication, social interaction, and behavior. Identifying ASD early helps children and families access support services sooner. Pupillometry is a way of measuring the nervous system and brain function by recording the pupil response to light. It is a non-invasive technology that may support screening practices by providing health care providers with an objective physical measure to bolster behavioral screening tools used to identify children with ASD . This study is evaluating how well the APS Detect™ handheld pupillometer works to help screen for ASD in children 2 to 4 years of age during routine pediatric healthcare visits. This investigational device measures the child\'s pupil response to light and uses these measurements to estimate the likelihood of ASD. Researchers will compare screening results using the APS Detect with the results of reference standard clinical assessments used to determine whether a child has autism. The study will assess how accurately the device identifies children with autism compared to children with typical development based on the Autism Pupil Screen (APS) score. The study will also evaluate whether the device provides the same results when used by different healthcare professionals. Information collected during this study will be used to evaluate device performance, safety, and suitability for use in pediatric healthcare settings and may support future review by the U.S. Food and Drug Administration (FDA).