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

NCT02822612 | Completed Results

• 1 other identifier: 15/LO/1756
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

optical coherence tomography; optical imaging; retinal imaging

Outcome Measures

Primary Outcomes (1)

• Total Examination Time

  Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.

  6 months

Secondary Outcomes (2)

• Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire

  6 months

• Number of Participants That Presented Gradable Data, by Examination Type

  4 months

Study Arms (4)

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

Glaucoma

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

Device: Binocular OCT prototype

Strabismus

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

Device: Binocular OCT prototype

Healthy volunteers

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

Device: Binocular OCT prototype

Interventions

Binocular OCT prototype 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; Healthy volunteers; Retinal Disease; Strabismus

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Moorfields Eye Hospital NHS FT

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma; Retinal Diseases; Strabismus

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases

Results Point of Contact

• Title: Pearse Keane
• Organization: Moorfields Eye Hospital NHS Foundation Trust

pearse.keane@moorfields.nhs.uk

02072533411

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 4, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 26, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Locations

GB (1)