Abstract Body: Introduction The pupillary light reflex (PLR) evaluation plays a critical role in stroke evaluation as a vital indicator of neurological function and autonomic regulation. Accurate measurement of PLR is critical in patients with cerebro-vascular incidents (CVIs). We introduce a novel iPhone-based pupillometry device (AI Pupillometry System, Solvemed Inc.) designed to ensure reliable and consistent PLR measurements, independent of the distance between the device and the patient’s eye. This innovation aims to streamline pupillary assessment and enhance diagnostic precision in diverse clinical environments but with specific use in the context of CVIs.
Materials and Methods Smartphone flashlight is used to induce the pupillary response, while simultaneous distance measurement allows real-time calibration of pupil size, ensuring accuracy regardless of measurement distance. A cohort of 189 healthy volunteers was recruited to validate the device’s performance. Participants were exposed to controlled light stimuli, and pupillary constriction and dilation metrics were recorded. Key parameters measured included latency, amplitude and constriction velocity. A regression analysis was conducted to assess the influence of eye-to-device distance on these different pupillometric measurements. Data was analysed to assess the accuracy, repeatability, and sensitivity of the device.
Results The novel pupillometry device demonstrated consistent performance across all measured parameters, with only small impact on pupillary response metrics, specifically latency (ß=0.18, p<0.05), amplitude (ß=-0.00, p<0.05), constriction velocity (ß=0.01, p<0.05) across different measurement distances. Regression analysis confirmed that changes in the distance between the device and the eye had a consistent but only very small impact on measurement accuracy. Other factors are predictive of the outcome of the assessment. The device exhibited high precision and repeatability across repeated trials.
Conclusion The novel pupillometry device represents a significant advancement in neurological diagnostics by providing distance-independent PLR measurements. This innovation enhances the reliability and consistency of pupillary assessments, making it particularly useful in clinical environments where precise positioning may be challenging. The device has the potential to improve both the efficiency and accuracy of pupillary assessments, especially in critical care and emergency settings.