NCT02822612

The EASE Study - Human Factor and Usability Testing of a Binocular OCT System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Glaucoma
• Retinal Disease
• Strabismus
• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Binocular OCT prototype	Testing will begin using a prototype binocular OCT system. Subjects will undergo the full suite of diagnostic assessments offered by the system at that time (i.e., visual acuity, ophthalmic history, pupillometry, ocular motility, perimetry, anterior segment and posterior segment OCT imaging).

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-07-04
• Last updated: 2020-03-26
• Results posted: 2020-03-26

Locations

1 site across 1 country: United Kingdom