Visual ImpairmentNCT04482387
DigiVis: Self-testing Vision App for Telephone Consultations
A study testing DigiVis visual acuity app in people with Visual Impairment and Amblyopia Suspect, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This trial aims to assess the accuracy and test-retest variability of a new digital app which enables community visual acuity testing without requirement of an trained examiner. Read more about this study
- Who is it for?
- Ages 5 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment, Amblyopia Suspect
- What is being tested?
- DigiVis visual acuity app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2020to 1 Aug 2021
- Phase
- Interventional
- 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 5 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age between 5 and 85 years
- Previous recorded visual acuity of at least +0.8 logMAR in or both eyes
Who cannot join
- Individuals with poor conversant English
- Individuals with cognitive impairment
- Subjects unable to access the internet on two digital devices
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Trust
Cambridge, Cambs, CB2 0QQ
About this study
Official title: DigiVis: Validation of Self-testing Visual Acuity Web-based App to Aid Ophthalmic Telephone Consultations During Covid19 Lockdown and Subsequent Social Distancing Crisis
This trial aims to assess the accuracy and test-retest variability of a new digital app which enables community visual acuity testing without requirement of an trained examiner.
Read the detailed description
Eye problems like macular degeneration and amblyopia (lazy eye) require regular monitoring to prevent permanent visual impairment. Over 2000 patients a month are seen in Cambridge University Hospitals National Health Service Trust (CUH) eye clinics; concern about Covid-19 infection has led to over 80% of consultations being conducted by telephone with few clinical clues to inform decision making. Patients will face long delays even when routine clinics restart: there is no doubt that some will suffer preventable visual loss.
DigiVis is a web-based vision testing app enabling self-testing of vision at home. Early testing and patient feedback is positive: 80% of children prefer DigiVis to regular testing. The investigators wish to test how accurately the app works for home use, by asking older children and adults to self-test their vision prior to their planned face to face clinic appointment. Once tested, DigiVis will be available free of charge to patients, not only during the Covid-19 crisis, but also to support telephonic consultations in the future.
Visual acuity (VA) is a fundamental measure of vision required for all ophthalmic assessments. It is measured by health professionals using vision charts. DigiVis is a new app which enables self-testing of VA using two wirelessly connected digital devices. By matching letters on a handheld device to those displayed on the second device a distance away, threshold VA can be measured using a staircase algorithm. The distance and scaling of the test is vital to its accuracy and a concept (patent filed by Cambridge Enterprise) in DigiVis enables this without the need for manual distance measurement or an observer.
Early validation using two tablet computers in 150 clinic patients has given positive results, both in testing accuracy and patient feedback. With the current Covid-19 crisis limiting face to face appointments, there is an urgent need for accurate home VA assessment. The DigiVis app has been re-coded for free website delivery for this purpose.
The investigators wish to formally validate DigiVis home testing following Conformitè Europëenne (CE class I) marking so that it can be recommended for clinical use. 250 patients will be invited to self-test their VA twice using DigiVis prior to a planned face to face clinic appointment. The test-retest variability and comparison of DigiVis VA to chart based assessment will be compared.
- Conditions
- Visual Impairment, Amblyopia Suspect
- Being tested
- DigiVis visual acuity app
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigiVis visual acuity appDevice
Self-testing of visual acuity app on two occasions
| Study group | Role | What they receive |
|---|---|---|
| Subjects recruited to visual acuity testing | Other | All recruited subjects will have the intervention (Digivis visual acuity self-testing) and the standard clinical visual acuity assessment in clinic. Receives: Device: DigiVis visual acuity app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Bias Between the Difference Between DigiVis and Standard Visual Assessment Compared to the Mean of DigiVis and Standard Visual Assessment
The mean bias (difference) in visual acuity assessment score between the difference in DigiVis and standard testing in logMAR units and the mean of DigiVis and standard testing in logMAR units was calculated. Where 0.00 logMAR is the value representing perfect distance visual acuity (equivalent to 20/20 Snellen acuity) and 1.00 logMAR is the value representing worst distance visual acuity (equivalent to 20/200 Snellen acuity).
Measured: within 30 days
Secondary outcomes (1)
Mean Bias Between Repeated DigiVis Test Assessments
Mean bias between the difference of two DigiVis visual acuity assessments compared to the mean of two digiVis assessments measured in logMAR units.
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start24 Jul 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Patients will test their own vision twice using the DigiVis app twice, subsequently they will have visual acuity assessment in eye clinic by a trained examiner. The results of visual acuity will be compared using Bland Altman statistical analysis.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Allen, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Stephen E Kelleher, Study director, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482387
- Sponsor's protocol ID
- IRAS196573
- Status last verified
- Feb 2024
- First submitted
- 17 Jul 2020
- Last updated
- 5 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rono HK, Bastawrous A, Macleod D, Wanjala E, Di Tanna GL, Weiss HA, Burton MJ. Smartphone-based screening for visual impairment in Kenyan school children: a cluster randomised controlled trial. Lancet Glob Health. 2018 Aug;6(8):e924-e932. doi: 10.1016/S2214-109X(18)30244-4.
PubMed 30012273Bastawrous A, Rono HK, Livingstone IA, Weiss HA, Jordan S, Kuper H, Burton MJ. Development and Validation of a Smartphone-Based Visual Acuity Test (Peek Acuity) for Clinical Practice and Community-Based Fieldwork. JAMA Ophthalmol. 2015 Aug;133(8):930-7. doi: 10.1001/jamaophthalmol.2015.1468.
PubMed 26022921Thirunavukarasu AJ, Mullinger D, Rufus-Toye RM, Farrell S, Allen LE. Clinical validation of a novel web-application for remote assessment of distance visual acuity. Eye (Lond). 2022 Oct;36(10):2057-2061. doi: 10.1038/s41433-021-01760-2. Epub 2021 Aug 30.
PubMed 34462579
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DigiVis: Validation of Self-testing Visual Acuity Web-based App to Aid Ophthalmic Telephone Consultations During Covid19 Lockdown and Subsequent Social Distancing Crisis
- ClinicalTrials.gov ID
- NCT04482387
- Acronym / sponsor ID
- IRAS196573
- Conditions
- Visual Impairment, Amblyopia Suspect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to assess the accuracy and test-retest variability of a new digital app which enables community visual acuity testing without requirement of an trained examiner.
Detailed description
Eye problems like macular degeneration and amblyopia (lazy eye) require regular monitoring to prevent permanent visual impairment. Over 2000 patients a month are seen in Cambridge University Hospitals National Health Service Trust (CUH) eye clinics; concern about Covid-19 infection has led to over 80% of consultations being conducted by telephone with few clinical clues to inform decision making. Patients will face long delays even when routine clinics restart: there is no doubt that some will suffer preventable visual loss.
DigiVis is a web-based vision testing app enabling self-testing of vision at home. Early testing and patient feedback is positive: 80% of children prefer DigiVis to regular testing. The investigators wish to test how accurately the app works for home use, by asking older children and adults to self-test their vision prior to their planned face to face clinic appointment. Once tested, DigiVis will be available free of charge to patients, not only during the Covid-19 crisis, but also to support telephonic consultations in the future.
Visual acuity (VA) is a fundamental measure of vision required for all ophthalmic assessments. It is measured by health professionals using vision charts. DigiVis is a new app which enables self-testing of VA using two wirelessly connected digital devices. By matching letters on a handheld device to those displayed on the second device a distance away, threshold VA can be measured using a staircase algorithm. The distance and scaling of the test is vital to its accuracy and a concept (patent filed by Cambridge Enterprise) in DigiVis enables this without the need for manual distance measurement or an observer.
Early validation using two tablet computers in 150 clinic patients has given positive results, both in testing accuracy and patient feedback. With the current Covid-19 crisis limiting face to face appointments, there is an urgent need for accurate home VA assessment. The DigiVis app has been re-coded for free website delivery for this purpose.
The investigators wish to formally validate DigiVis home testing following Conformitè Europëenne (CE class I) marking so that it can be recommended for clinical use. 250 patients will be invited to self-test their VA twice using DigiVis prior to a planned face to face clinic appointment. The test-retest variability and comparison of DigiVis VA to chart based assessment will be compared.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will test their own vision twice using the DigiVis app twice, subsequently they will have visual acuity assessment in eye clinic by a trained examiner. The results of visual acuity will be compared using Bland Altman statistical analysis.
| Arm | Type | Receives |
|---|---|---|
| Subjects recruited to visual acuity testing | Other | Device: DigiVis visual acuity appAll recruited subjects will have the intervention (Digivis visual acuity self-testing) and the standard clinical visual acuity assessment in clinic. |
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 5 and 85 years
- Previous recorded visual acuity of at least +0.8 logMAR in or both eyes
Key exclusion criteria (3 listed)
- Individuals with poor conversant English
- Individuals with cognitive impairment
- Subjects unable to access the internet on two digital devices
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 |
|---|---|---|
| DigiVis visual acuity appSelf-testing of visual acuity app on two occasions | Device | Subjects recruited to visual acuity testing |
Primary outcome
Mean Bias Between the Difference Between DigiVis and Standard Visual Assessment Compared to the Mean of DigiVis and Standard Visual Assessment
Time frame: within 30 days
The mean bias (difference) in visual acuity assessment score between the difference in DigiVis and standard testing in logMAR units and the mean of DigiVis and standard testing in logMAR units was calculated. Where 0.00 logMAR is the value representing perfect distance visual acuity (equivalent to 20/20 Snellen acuity) and 1.00 logMAR is the value representing worst distance visual acuity (equivalent to 20/200 Snellen acuity).
1 secondary outcome
Mean Bias Between Repeated DigiVis Test Assessments
Time frame: within 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30012273Rono HK, Bastawrous A, Macleod D, Wanjala E, Di Tanna GL, Weiss HA, Burton MJ. Smartphone-based screening for visual impairment in Kenyan school children: a cluster randomised controlled trial. Lancet Glob Health. 2018 Aug;6(8):e924-e932. doi: 10.1016/S2214-109X(18)30244-4.
- Background: PubMed 26022921Bastawrous A, Rono HK, Livingstone IA, Weiss HA, Jordan S, Kuper H, Burton MJ. Development and Validation of a Smartphone-Based Visual Acuity Test (Peek Acuity) for Clinical Practice and Community-Based Fieldwork. JAMA Ophthalmol. 2015 Aug;133(8):930-7. doi: 10.1001/jamaophthalmol.2015.1468.
- Background: PubMed 34462579Thirunavukarasu AJ, Mullinger D, Rufus-Toye RM, Farrell S, Allen LE. Clinical validation of a novel web-application for remote assessment of distance visual acuity. Eye (Lond). 2022 Oct;36(10):2057-2061. doi: 10.1038/s41433-021-01760-2. Epub 2021 Aug 30.
- Individual participant dataSharing planned: No
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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.
Stephen E Kelleher study director
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DigiVis visual acuity app in people with Visual Impairment and Amblyopia Suspect, run by Cambridge University Hospitals NHS Foundation Trust 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 2 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 5 Aug 2024. 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 5 Aug 2024). 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?
Mean Bias Between the Difference Between DigiVis and Standard Visual Assessment Compared to the Mean of DigiVis and Standard Visual Assessment (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482387, which also lists 3 linked publications.
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 5 Aug 2024.