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

• Sponsor: University College, London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02822612
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 11.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Retinal Disease; Strabismus; Healthy Volunteers	Device: Binocular OCT prototype

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: 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
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	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).

Outcome Measures

Primary Outcome Measures

1. Total Examination Time [6 months]

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

Secondary Outcome Measures

1. 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.

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moorfields Eye Hospital NHS FT	London		United Kingdom	EC1V 2PD

Sponsors and Collaborators

• University College, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University College, London
• ClinicalTrials.gov Identifier: NCT02822612
• Other Study ID Numbers: 15/LO/1756
• First Posted: Jul 4, 2016
• Last Update Posted: Mar 26, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by University College, London: optical coherence tomography; optical imaging; retinal imaging
• Additional relevant MeSH terms: Strabismus; Retinal Diseases

Study Results

Participant Flow

Arm/Group Title	Retinal Disease	Glaucoma	Strabismus	Ocular Comorbidities	Healthy Volunteers
Arm/Group Description	Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).	Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Fifteen healthy volunteers with no self-reported history of ocular disease.
Period Title: Overall Study
STARTED	14	13	14	4	15
COMPLETED	14	13	14	4	15
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Retinal Disease	Glaucoma	Strabismus	Ocular Comorbidities	Healthy Volunteers	Total
Arm/Group Description	Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).	Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Fifteen healthy volunteers with no self-reported history of ocular disease.	Total of all reporting groups
Overall Participants	14	13	14	4	15	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	4 28.6%	5 38.5%	10 71.4%	1 25%	12 80%	32 53.3%
>=65 years	10 71.4%	8 61.5%	4 28.6%	3 75%	3 20%	28 46.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.0 (11.4)	64.1 (14.7)	50.8 (19.1)	70.5 (8.0)	53.1 (11.2)	60.3 (16.1)
Sex: Female, Male (Count of Participants)
Female	6 42.9%	7 53.8%	7 50%	2 50%	9 60%	31 51.7%
Male	8 57.1%	6 46.2%	7 50%	2 50%	6 40%	29 48.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	14 100%	13 100%	14 100%	4 100%	15 100%	60 100%
Visual acuity (better eye) (logMAR) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR]	0.35 (0.24)	0.10 (0.12)	-0.04 (0.08)	0.24 (0.42)	0.01 (0.14)	0.18 (0.25)
Visual acuity (worse eye) (logMAR) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR]	0.68 (0.34)	0.20 (0.12)	0.24 (0.27)	0.63 (0.53)	0.02 (0.15)	0.33 (0.42)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Retinal Disease	Glaucoma	Strabismus	Ocular Comorbidities	Healthy Volunteers
Arm/Group Description	Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).	Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Fifteen healthy volunteers with no self-reported history of ocular disease.
Measure Participants	14	13	14	4	15
Median (Inter-Quartile Range) [seconds]	728.6	676.7	707.6	620.6	637.8

2. Secondary Outcome

Title	Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire
Description	Participants rated ease of use, duration, and appeal on a 5-point Likert scale in a post-test questionnaire.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Results based on a post-test questionnaire. Participants rated ease of use (from 1 to 5: 1 = very difficult, 5 = very easy), duration (from 1 to 5: 1 = very long, 5 = very short), and appeal (from 1 to 5: 1 = very unappealing, 5 = very appealing) on a 5-point Likert scale.

Arm/Group Title	Retinal Disease	Glaucoma	Strabismus	Ocular Comorbidities	Healthy Volunteers
Arm/Group Description	Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).	Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Fifteen healthy volunteers with no self-reported history of ocular disease.
Measure Participants	14	13	14	4	15
Rated ≥ 4 ease of use	9 64.3%	11 84.6%	12 85.7%	2 50%	13 86.7%
Rated ≥ 4 duration	10 71.4%	7 53.8%	8 57.1%	1 25%	8 53.3%
Rated ≥ 4 appeal	13 92.9%	11 84.6%	12 85.7%	3 75%	13 86.7%

3. Secondary Outcome

Title	Number of Participants That Presented Gradable Data, by Examination Type
Description	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).
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Retinal Disease	Glaucoma	Strabismus	Ocular Comorbidities	Healthy Volunteers
Arm/Group Description	Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).	Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Fifteen healthy volunteers with no self-reported history of ocular disease.
Measure Participants	14	13	14	4	15
Anterior segment imaging	14 100%	13 100%	14 100%	4 100%	14 93.3%
Posterior segment imaging	12 85.7%	12 92.3%	12 85.7%	3 75%	13 86.7%
Vitreous imaging	12 85.7%	12 92.3%	12 85.7%	3 75%	13 86.7%
Motility	10 71.4%	9 69.2%	12 85.7%	2 50%	14 93.3%
Visual acuity	13 92.9%	12 92.3%	13 92.9%	4 100%	15 100%
Suprathreshold perimetry	13 92.9%	12 92.3%	14 100%	4 100%	15 100%
Pupillometry	11 78.6%	10 76.9%	13 92.9%	4 100%	13 86.7%

Adverse Events

Arm/Group Title	Retinal Disease		Glaucoma		Strabismus		Ocular Comorbidities		Healthy Volunteers
Arm/Group Description	Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration [AMD], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).		Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis).		Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).		Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.		Fifteen healthy volunteers with no self-reported history of ocular disease.
All Cause Mortality
	Retinal Disease		Glaucoma		Strabismus		Ocular Comorbidities		Healthy Volunteers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Retinal Disease		Glaucoma		Strabismus		Ocular Comorbidities		Healthy Volunteers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)		0/14 (0%)		0/4 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Retinal Disease		Glaucoma		Strabismus		Ocular Comorbidities		Healthy Volunteers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)		0/14 (0%)		0/4 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.