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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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 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.


Detailed Summary:
Sponsor: University College, London

Current Primary Outcome: Ease of use of the binocular OCT prototype [ Time Frame: 4 months ]

The primary objective of the study will be to judge the ease of use and interactive qualities of the device, with a view to predicting likely function in a clinical setting (esp., in visually impaired and elderly populations with chronic eye disease).


Original Primary Outcome: Ease of use of the binocular OCT prototype [ Time Frame: 3 months ]

The primary objective of the study will be to judge the ease of use and interactive qualities of the device, with a view to predicting likely function in a clinical setting (esp., in visually impaired and elderly populations with chronic eye disease).


Current Secondary Outcome:

  • Assessing subjective appeal of the binocular OCT prototype. [ Time Frame: 4 months ]
    To assess the subjective appeal of the device to patients.
  • Identify potential user errors [ Time Frame: 4 months ]
    To identify potential user errors, particularly those with a likelihood of generating erroneous examination findings (e.g., failure to comply with device instructions or errors in voice recognition).


Original Secondary Outcome:

  • Assessing subjective appeal of the binocular OCT prototype. [ Time Frame: 3 months ]
    To assess the subjective appeal of the device to patients.
  • Identify potential user errors [ Time Frame: 3 months ]
    To identify potential user errors, particularly those with a likelihood of generating erroneous examination findings (e.g., failure to comply with device instructions or errors in voice recognition).


Information By: University College, London

Dates:
Date Received: June 23, 2016
Date Started: May 2016
Date Completion:
Last Updated: October 19, 2016
Last Verified: June 2016