Healthy Volunteers Clinical Trial
Official title:
A Prospective Single-Site Non-Interventional Study to Evaluate Human Factors and Usability of Automated, Comprehensive Ocular Examination in Elderly and Visually Impaired Populations Using a Prototype Binocular Optical Coherence Tomography System
Ophthalmology is among the most technology driven of all medical specialties, with advanced
medical imaging devices - and specialised computer software - increasingly adopted for
routine clinical use. While many such devices are capable of completing specific tasks, lack
of "usability" prevents their widespread adoption (i.e., such devices are not easy to learn
and remember, or are not efficient or subjectively pleasing to use). Moreover, devices that
are difficult to use expose patients to clinical risk as a result of human error during
usage.
With the introduction of a new medical technology, it is essential, therefore, to have a deep
understanding of patients, what they need, what they value, their abilities, and also their
limitations.
Human factor and usability testing, also known as "human factor engineering", deals with the
formal study of people's interaction with their environment (in this case, the binocular
optical coherence tomography (OCT) device). Structured, patient-centred, usability testing is
essential to the design, clinical validation, regulatory approval, and widespread
implementation, of all new medical devices. This is particularly the case for a putative
binocular OCT system - a device intended for automated use in visually impaired, often
elderly, populations. Although the binocular OCT is already at an advanced stage of hardware
development, the EASE study will facilitate an iterative process of operating software and
workflow modifications to optimize the device for use in these populations.
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