GlaucomaEASENCT02822612
The EASE Study - Human Factor and Usability Testing of a Binocular OCT System
An observational study of Glaucoma and Retinal Disease, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Retinal Disease, Strabismus
- What is being tested?
- Binocular OCT prototype
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Binocular OCT prototype
- Keywords
- optical coherence tomography, optical imaging, retinal imaging
- Medical subject headings
- Glaucoma, Retinal Diseases, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular OCT prototypeDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Retinal Disease | Fifteen subjects with retinal disease. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. Receives: Device: Binocular OCT prototype | |
| Glaucoma | Fifteen subjects with glaucoma. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. Receives: Device: Binocular OCT prototype | |
| Strabismus | Fifteen subjects with strabismus. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. Receives: Device: Binocular OCT prototype | |
| Healthy volunteers | Fifteen healthy volunteers. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. Receives: Device: Binocular OCT prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Examination Time
Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822612
- Sponsor's protocol ID
- 15/LO/1756
- Acronym
- EASE
- Status last verified
- Mar 2020
- First submitted
- 23 Jun 2016
- Last updated
- 26 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02822612
- Acronym / sponsor ID
- EASE / 15/LO/1756
- Conditions
- Glaucoma, Retinal Disease, Strabismus, Healthy Volunteers
- Keywords
- optical coherence tomography, optical imaging, retinal imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Posted 26 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retinal Disease | – | Device: Binocular OCT prototypeFifteen subjects with retinal disease. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. |
| Glaucoma | – | Device: Binocular OCT prototypeFifteen subjects with glaucoma. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. |
| Strabismus | – | Device: Binocular OCT prototypeFifteen subjects with strabismus. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. |
| Healthy volunteers | – | Device: Binocular OCT prototypeFifteen healthy volunteers. Each participant will attend for a single study visit, lasting approximately 1 hour in duration. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binocular OCT prototypeTesting 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). | Device | Glaucoma, Healthy volunteers, Retinal Disease, Strabismus |
Primary outcome
Total Examination Time
Time frame: 6 months
Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.
2 secondary outcomes
Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire
Time frame: 6 months
Number of Participants That Presented Gradable Data, by Examination Type
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Retinal Disease, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Examination Time (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.