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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retinal Disease | Fifteen subjects with retinal disease. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. |
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| Glaucoma | Fifteen subjects with glaucoma. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. |
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| Strabismus | Fifteen subjects with strabismus. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. |
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| Healthy volunteers | Fifteen healthy volunteers. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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Inclusion criteria for participants with chronic eye disease will include:
Exclusion criteria for participants with chronic eye disease will include:
Inclusion criteria for healthy subjects will include:
Exclusion criteria for healthy subjects will include:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital NHS FT | London | EC1V 2PD | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Glaucoma | Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis). |
| FG002 | Strabismus | Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia). |
| FG003 | 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. |
| FG004 | Healthy Volunteers | Fifteen healthy volunteers with no self-reported history of ocular disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Glaucoma |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Examination Time | Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated. | Posted | Median | Inter-Quartile Range | seconds | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pearse Keane | Moorfields Eye Hospital NHS Foundation Trust | 02072533411 | pearse.keane@moorfields.nhs.uk |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D012164 | Retinal Diseases |
| D013285 | Strabismus |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
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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 |
Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis). |
| BG002 | Strabismus | Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia). |
| BG003 | 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. |
| BG004 | Healthy Volunteers | Fifteen healthy volunteers with no self-reported history of ocular disease. |
| BG005 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Visual acuity (better eye) | Mean | Standard Deviation | logMAR |
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| Visual acuity (worse eye) | Mean | Standard Deviation | logMAR |
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| OG002 | Strabismus | Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia). |
| OG003 | 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. |
| OG004 | Healthy Volunteers | Fifteen healthy volunteers with no self-reported history of ocular disease. |
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| 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. | 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. | Posted | Count of Participants | Participants | 6 months |
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| 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). | Posted | Count of Participants | Participants | 4 months |
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| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Glaucoma | Thirteen participants had glaucoma only (12 with primary open angle glaucoma [POAG], 1 with glaucoma secondary to hypertensive uveitis). | 0 | 13 | 0 | 13 |
| EG002 | Strabismus | Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia). | 0 | 14 | 0 | 14 |
| EG003 | 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. | 0 | 4 | 0 | 4 |
| EG004 | Healthy Volunteers | Fifteen healthy volunteers with no self-reported history of ocular disease. | 0 | 15 | 0 | 15 |
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| D009422 |
| Nervous System Diseases |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Rated ≥ 4 duration |
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| Rated ≥ 4 appeal |
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| Posterior segment imaging |
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| Vitreous imaging |
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| Motility |
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| Visual acuity |
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| Suprathreshold perimetry |
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| Pupillometry |
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