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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Strabismus; Healthy Volunteers; Retinal Disease
• Intervention / Treatment: Device: Binocular OCT prototype

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS FT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic eye disease (retinal disease, glaucoma, and strabismus) will be recruited from appropriate eye clinics at Moorfields Eye Hospital and from a patient advisory group established for this purpose.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retinal Disease; Fifteen subjects with retinal disease. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.	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).
Glaucoma; Fifteen subjects with glaucoma. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.	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).
Strabismus; Fifteen subjects with strabismus. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.	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).
Healthy volunteers; Fifteen healthy volunteers. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Examination Time	Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: optical coherence tomography; optical imaging; retinal imaging
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Retinal Diseases; Strabismus
• Other Study ID Numbers: 15/LO/1756