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

Completed

Conditions: Glaucoma
Retinal Disease
Healthy Volunteers
Strabismus

Interventions: Device: Binocular OCT prototype

Registration Number: NCT02822612

Lead Sponsor: University College, London

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retinal Disease	Binocular OCT prototype	Fifteen subjects with retinal disease. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.
Strabismus	Binocular OCT prototype	Fifteen subjects with strabismus. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.
Healthy volunteers	Binocular OCT prototype	Fifteen healthy volunteers. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.
Glaucoma	Binocular OCT prototype	Fifteen subjects with glaucoma. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.

Primary Outcome Measures

Name	Time	Method
Total Examination Time	6 months	Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Presented Gradable Data, by Examination Type	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).
Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire	6 months	Participants rated ease of use, duration, and appeal on a 5-point Likert scale in a post-test questionnaire.