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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glaucoma, Retinal Disease, Strabismus, Healthy Volunteers

Intervention / Treatment
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* Device: Binocular OCT prototype


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retinal Disease<br>Fifteen subjects with retinal disease. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. | Device: Binocular OCT prototype<br>* 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).<br>|
| Glaucoma<br>Fifteen subjects with glaucoma. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. | Device: Binocular OCT prototype<br>* 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).<br>|
| Strabismus<br>Fifteen subjects with strabismus. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. | Device: Binocular OCT prototype<br>* 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).<br>|
| Healthy volunteers<br>Fifteen healthy volunteers. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. | Device: Binocular OCT prototype<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optical imaging, optical coherence tomography, retinal imaging