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

NCT ID: NCT02822612

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-10-31

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.

Conditions

Glaucoma; Retinal Disease; Strabismus; Healthy Volunteers

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Retinal Disease

Fifteen subjects with retinal disease. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.

Binocular OCT prototype

Intervention Type: 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).

Glaucoma

Fifteen subjects with glaucoma. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.

Binocular OCT prototype

Intervention Type: 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).

Strabismus

Fifteen subjects with strabismus. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.

Binocular OCT prototype

Intervention Type: 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).

Healthy volunteers

Fifteen healthy volunteers. Each participant will attend for a single study visit, lasting approximately 1 hour in duration.

Binocular OCT prototype

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Moorfields Eye Hospital NHS FT

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

15/LO/1756

Identifier Type: -

Identifier Source: org_study_id