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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DigiVis visual acuity app | Device | Self-testing of visual acuity app on two occasions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen E Kelleher | Cambridge University Hospitals NHS Foundation Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge University Hospitals NHS Trust | Cambridge | Cambs | CB2 0QQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30012273 | Background | 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. | |
| 26022921 | Background | Bastawrous 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. |
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All participants underwent both the DigiVis testing and the standard clinical visual acuity test.
Over a two month period, research administrators posted study invitations and information leaflets to all patients due to attend an eye clinic appointment. Inclusion criteria were: age over 4 years, VA of +0.8 (6/38 Snellen) or better in each eye and no documentation of cognitive disability. The clinician researcher phoned the patient to explain the study, take verbal consent and give password access to the DigiVis test.
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Right eye data for all 120 participants to the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Right eye data for all 120 participants to the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | 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). | All participants had their right eye tested firstly with the standard chart technique and subsequently with DigiVis | Posted | Mean | Standard Deviation | logMAR | within 30 days |
|
uo to 60 days
No adverse events
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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 | All Study Participants | Right eye data for all 120 participants to the study. |
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The study recruited a smaller number of participants than originally intended but 120 participants was sufficient to enable narrow 95% confidence limits.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Kelleher | Cambridge University Hospitals NHS Foundation Trust | 01223217418 | research@addenbrookes.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2020 | Aug 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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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.
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| 34462579 | Background | Thirunavukarasu 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | DigiVis Vision Testing | The same cohort of patients then had DigiVis vision testing |
|
|
| Secondary | 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. | Participants able to undertake DigiVis testing twice to analyse test repeatability | Posted | Mean | Standard Deviation | logMAR | within 30 days |
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| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |