DigiVis: Self-testing Vision App for Telephone Consultations

Study Overview
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Brief Summary
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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.

Detailed Description
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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 NHS 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.

Official Title
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DigiVis: Validation of Self-testing Visual Acuity Web-based App to Aid Ophthalmic Telephone Consultations During Covid19 Lockdown and Subsequent Social Distancing Crisis

Conditions
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Visual Impairment, Amblyopia Suspect

Intervention / Treatment
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* Device: DigiVis visual acuity app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 5 and 85 years Previous recorded visual acuity of at least +0.8 logMAR in or both eyes Exclusion Criteria: Individuals with poor conversant English Individuals with cognitive impairment Subjects unable to access the internet on two digital devices

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: subjects recruited to visual acuity testing<br>All recruited subjects will have the intervention (Digivis visual acuity self-testing) and the standard clinical visual acuity assessment in clinic. | Device: DigiVis visual acuity app<br>* Self-testing of visual acuity app on two occasions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of visual acuity measurement using DigiVis testing and standard visual acuity testing | Measurement bias in logMAR units between DigiVis testing and standard visual acuity testing score compared to | within 30 days | 
| Levels of Agreement between DigiVis testing and standard visual acuity testing | Upper and lower levels of agreement measured in logMAR units | within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DigiVis test repeatability | Measurement of test-retest variability | within 30 days |