Clinical Trial

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

This study is an FDA clinical trial sponsored by Schweitzer Engineering Laboratories, Inc. (SEL). The trial will examine the effectiveness of an investigational device designed to help healthcare professionals screen for ASD in children ages two through four years old in routine healthcare settings. This clinical trial uses an investigational handheld pupillometer that a clinician will position in front of each eye, one at a time. The device will briefly shine light into each eye, measure the child’s pupillary light reflex (PLR), and compare the measurements with data used to identify typical and atypical development. This device is not cleared for safety and effectiveness by the FDA. Parents will be asked to provide information about their child's development and participate in play-based testing with their child. The trial is being conducted at outpatient pediatric and family medicine clinics in the Inland Northwest.Learn about study participation by reading and downloading the study flyer here. Learn more about the trial at clinicaltrials.gov.

Healthcare professional measuring a child's height during a clinic visit. — Interested in joining the trial?
For more information, please contact the SEL clinical research coordinator at clinicaltrials@selinc.com or 509.334.8800.

This study has been approved for human subject participation by the Washington State University Institutional Review Board, IRB Approved Protocol # 26-0339-1.