Glaucoma, Healthy Volunteers, Retinal Disease, Strabismus
Conditions
Keywords
optical coherence tomography, optical imaging, retinal imaging
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.
Interventions
DEVICEBinocular 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).
Sponsors
University College, London
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Examination Time | 6 months | Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retinal Disease 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). | 14 |
| Glaucoma Thirteen participants had glaucoma only (12 with primary open angle glaucoma \[POAG\], 1 with glaucoma secondary to hypertensive uveitis). | 13 |
| Strabismus Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia). | 14 |
| Ocular Comorbidities 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. | 4 |
| Healthy Volunteers Fifteen healthy volunteers with no self-reported history of ocular disease. | 15 |
| Total | 60 |
Baseline characteristics
| Characteristic | Strabismus | Ocular Comorbidities | Retinal Disease | Healthy Volunteers | Total | Glaucoma |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 10 Participants | 3 Participants | 28 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 1 Participants | 4 Participants | 12 Participants | 32 Participants | 5 Participants |
| Age, Continuous | 50.8 years STANDARD_DEVIATION 19.1 | 70.5 years STANDARD_DEVIATION 8 | 71.0 years STANDARD_DEVIATION 11.4 | 53.1 years STANDARD_DEVIATION 11.2 | 60.3 years STANDARD_DEVIATION 16.1 | 64.1 years STANDARD_DEVIATION 14.7 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 14 participants | 4 participants | 14 participants | 15 participants | 60 participants | 13 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 6 Participants | 9 Participants | 31 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 8 Participants | 6 Participants | 29 Participants | 6 Participants |
| Visual acuity (better eye) | -0.04 logMAR STANDARD_DEVIATION 0.08 | 0.24 logMAR STANDARD_DEVIATION 0.42 | 0.35 logMAR STANDARD_DEVIATION 0.24 | 0.01 logMAR STANDARD_DEVIATION 0.14 | 0.18 logMAR STANDARD_DEVIATION 0.25 | 0.10 logMAR STANDARD_DEVIATION 0.12 |
| Visual acuity (worse eye) | 0.24 logMAR STANDARD_DEVIATION 0.27 | 0.63 logMAR STANDARD_DEVIATION 0.53 | 0.68 logMAR STANDARD_DEVIATION 0.34 | 0.02 logMAR STANDARD_DEVIATION 0.15 | 0.33 logMAR STANDARD_DEVIATION 0.42 | 0.20 logMAR STANDARD_DEVIATION 0.12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 13 | 0 / 14 | 0 / 4 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 14 | 0 / 4 | 0 / 15 |
Outcome results
Primary
Total Examination Time
Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Retinal Disease | Total Examination Time | 728.6 seconds |
| Glaucoma | Total Examination Time | 676.7 seconds |
| Strabismus | Total Examination Time | 707.6 seconds |
| Ocular Comorbidities | Total Examination Time | 620.6 seconds |
| Healthy Volunteers | Total Examination Time | 637.8 seconds |
Secondary
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).
Time frame: 4 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retinal Disease | Number of Participants That Presented Gradable Data, by Examination Type | Visual acuity | 13 Participants |
| Retinal Disease | Number of Participants That Presented Gradable Data, by Examination Type | Suprathreshold perimetry | 13 Participants |
| Retinal Disease | Number of Participants That Presented Gradable Data, by Examination Type | Posterior segment imaging | 12 Participants |
| Retinal Disease | Number of Participants That Presented Gradable Data, by Examination Type | Anterior segment imaging | 14 Participants |
| Retinal Disease | Number of Participants That Presented Gradable Data, by Examination Type | Pupillometry | 11 Participants |
| Retinal Disease | Number of Participants That Presented Gradable Data, by Examination Type | Vitreous imaging | 12 Participants |
| Retinal Disease | Number of Participants That Presented Gradable Data, by Examination Type | Motility | 10 Participants |
| Glaucoma | Number of Participants That Presented Gradable Data, by Examination Type | Visual acuity | 12 Participants |
| Glaucoma | Number of Participants That Presented Gradable Data, by Examination Type | Motility | 9 Participants |
| Glaucoma | Number of Participants That Presented Gradable Data, by Examination Type | Posterior segment imaging | 12 Participants |
| Glaucoma | Number of Participants That Presented Gradable Data, by Examination Type | Suprathreshold perimetry | 12 Participants |
| Glaucoma | Number of Participants That Presented Gradable Data, by Examination Type | Anterior segment imaging | 13 Participants |
| Glaucoma | Number of Participants That Presented Gradable Data, by Examination Type | Vitreous imaging | 12 Participants |
| Glaucoma | Number of Participants That Presented Gradable Data, by Examination Type | Pupillometry | 10 Participants |
| Strabismus | Number of Participants That Presented Gradable Data, by Examination Type | Vitreous imaging | 12 Participants |
| Strabismus | Number of Participants That Presented Gradable Data, by Examination Type | Posterior segment imaging | 12 Participants |
| Strabismus | Number of Participants That Presented Gradable Data, by Examination Type | Motility | 12 Participants |
| Strabismus | Number of Participants That Presented Gradable Data, by Examination Type | Suprathreshold perimetry | 14 Participants |
| Strabismus | Number of Participants That Presented Gradable Data, by Examination Type | Visual acuity | 13 Participants |
| Strabismus | Number of Participants That Presented Gradable Data, by Examination Type | Anterior segment imaging | 14 Participants |
| Strabismus | Number of Participants That Presented Gradable Data, by Examination Type | Pupillometry | 13 Participants |
| Ocular Comorbidities | Number of Participants That Presented Gradable Data, by Examination Type | Motility | 2 Participants |
| Ocular Comorbidities | Number of Participants That Presented Gradable Data, by Examination Type | Anterior segment imaging | 4 Participants |
| Ocular Comorbidities | Number of Participants That Presented Gradable Data, by Examination Type | Posterior segment imaging | 3 Participants |
| Ocular Comorbidities | Number of Participants That Presented Gradable Data, by Examination Type | Vitreous imaging | 3 Participants |
| Ocular Comorbidities | Number of Participants That Presented Gradable Data, by Examination Type | Visual acuity | 4 Participants |
| Ocular Comorbidities | Number of Participants That Presented Gradable Data, by Examination Type | Suprathreshold perimetry | 4 Participants |
| Ocular Comorbidities | Number of Participants That Presented Gradable Data, by Examination Type | Pupillometry | 4 Participants |
| Healthy Volunteers | Number of Participants That Presented Gradable Data, by Examination Type | Pupillometry | 13 Participants |
| Healthy Volunteers | Number of Participants That Presented Gradable Data, by Examination Type | Suprathreshold perimetry | 15 Participants |
| Healthy Volunteers | Number of Participants That Presented Gradable Data, by Examination Type | Posterior segment imaging | 13 Participants |
| Healthy Volunteers | Number of Participants That Presented Gradable Data, by Examination Type | Anterior segment imaging | 14 Participants |
| Healthy Volunteers | Number of Participants That Presented Gradable Data, by Examination Type | Motility | 14 Participants |
| Healthy Volunteers | Number of Participants That Presented Gradable Data, by Examination Type | Visual acuity | 15 Participants |
| Healthy Volunteers | Number of Participants That Presented Gradable Data, by Examination Type | Vitreous imaging | 13 Participants |
Secondary
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.
Time frame: 6 months
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retinal Disease | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 ease of use | 9 Participants |
| Retinal Disease | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 appeal | 13 Participants |
| Retinal Disease | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 duration | 10 Participants |
| Glaucoma | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 duration | 7 Participants |
| Glaucoma | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 ease of use | 11 Participants |
| Glaucoma | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 appeal | 11 Participants |
| Strabismus | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 duration | 8 Participants |
| Strabismus | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 ease of use | 12 Participants |
| Strabismus | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 appeal | 12 Participants |
| Ocular Comorbidities | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 ease of use | 2 Participants |
| Ocular Comorbidities | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 appeal | 3 Participants |
| Ocular Comorbidities | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 duration | 1 Participants |
| Healthy Volunteers | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 duration | 8 Participants |
| Healthy Volunteers | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 ease of use | 13 Participants |
| Healthy Volunteers | Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire | Rated ≥ 4 appeal | 13 Participants |