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

Conditions

Glaucoma Cranial Nerve Diseases Eye Diseases Healthy Volunteers Nervous System Diseases Ocular Hypertension Ocular Motility Disorders Retinal Disease Retinal Diseases Strabismus

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Moorfields Eye Hospital NHS FT

London, EC1V 2PD, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for participants with chronic eye disease will include:

Presence of retinal disease, glaucoma or strabismus
Male or female, aged 18 years or older
Ability to understand nature/purpose of the study and to provide informed consent
Ability to undergo binocular OCT imaging
Ability to follow instructions and complete the study
Ability to speak English

Exclusion criteria

for participants with chronic eye disease will include:

Optical media opacity sufficient to preclude adequate ocular imaging with OCT
Hearing impairment sufficient to interfere with hearing instructions
Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.

Inclusion criteria

for healthy subjects will include:

No self-reported ocular history (although wearing corrective prescription glasses is permitted)
Male or female, aged 18 years or older
Ability to understand nature/purpose of the study and to provide informed consent
Ability to undergo binocular OCT imaging
Ability to follow instructions and complete the study
Ability to speak English

Exclusion criteria

for healthy subjects will include:

Presence of ocular pathology
Hearing impairment sufficient to interfere with hearing instructions
Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.

Treatment and study plan

Binocular OCT prototype

Device

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).

Primary outcomes

Total Examination Time

Time frame: 6 months

Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.

Secondary outcomes

Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire

Time frame: 6 months

Participants rated ease of use, duration, and appeal on a 5-point Likert scale in a post-test questionnaire.
Number of Participants That Presented Gradable Data, by Examination Type

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).

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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

Acronym: EASE

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jul 4, 2016
Registry last updated: Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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