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Pupillometry via smartphone for low-resource settings

Piaggio Davide, Namm Georgy, Melillo Paolo, Simonelli Francesca, Iadanza Ernesto, Pecchia Leandro

Biocybernetics and Biomedical Engineering

2021

Vol. 41, no. 3

891--902

The photopupillary reflex regulates the pupil reaction to changing light conditions. Being controlled by the autonomic nervous system, it is a proxy for brain trauma and for the conditions of patients in critical care. A prompt evaluation of brain traumas can save lives. With a simple penlight, skilled clinicians can do that, whereas less specialized ones have to resort to a digital pupilometer. However, many low-income countries lack both specialized clinicians and digital pupilometers. This paper presents the early results of our study aiming at designing, prototyping and validating an app for testing the photopupillary reflex via Android, following the European Medical Device Regulation and relevant standards. After a manual validation, the prototype underwent a technical validation against a commercial Infrared pupilometer. As a result, the proposed app performed as well as the manual measurements and better than the commercial solution, with lower errors, higher and significant correlations, and significantly better Bland-Altman plots for all the pupillometry-related measures. The design of this medical device was performed based on our expertise in low-resource settings. This kind of environments imposes more stringent design criteria due to contextual challenges, including the lack of specialized clinicians, funds, spare parts and consumables, poor maintenance, and harsh environmental conditions, which may hinder the safe operationalization of medical devices. This paper provides an overview of how these unique contextual characteristics are cascaded into the design of an app in order to contribute to the Sustainable Development Goal 3 of the World Health Organization: Good health and well-being.