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

Healthy Volunteers Clinical Trial

— EASE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822612
• Other study ID #: 15/LO/1756
• Status: Completed
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Healthy Volunteers
• Retinal Disease
• Retinal Diseases
• Strabismus

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS FT	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Examination Time	Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.	6 months
Secondary	Number of Participants With Subjective Ratings = 4 on Post-Test Questionnaire	Participants rated ease of use, duration, and appeal on a 5-point Likert scale in a post-test questionnaire.	6 months
Secondary	Number of Participants That Presented Gradable Data, by Examination Type	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).	4 months