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Pupillometry via smartphone for low-resource settings

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Piaggio, Davide, Namm, Georgy, Melillo, Paolo, Simonelli , Francesca, Iadanza, Ernesto and Pecchia, Leandro (2021) Pupillometry via smartphone for low-resource settings. Biocybernetics and Biomedical Engineering, 41 (3). pp. 891-902. doi:10.1016/j.bbe.2021.05.012

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Official URL: https://doi.org/10.1016/j.bbe.2021.05.012

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Abstract

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.

Item Type: Journal Article
Subjects: Q Science > QP Physiology
R Medicine > R Medicine (General)
Divisions: Faculty of Science > Engineering
Library of Congress Subject Headings (LCSH): Biomedical engineering , Pupillometry, Medical electronics -- Design and construction
Journal or Publication Title: Biocybernetics and Biomedical Engineering
Publisher: Elsevier
ISSN: 0208-5216
Official Date: July 2021
Dates:
DateEvent
July 2021Published
8 June 2021Available
28 May 2021Accepted
Volume: 41
Number: 3
Page Range: pp. 891-902
DOI: 10.1016/j.bbe.2021.05.012
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
UNSPECIFIEDUniversity of Warwickhttp://dx.doi.org/10.13039/501100000741
EP/K503848/1[EPSRC] Engineering and Physical Sciences Research Councilhttp://dx.doi.org/10.13039/501100000266
EP/R511808/1[EPSRC] Engineering and Physical Sciences Research Councilhttp://dx.doi.org/10.13039/501100000266

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