- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04482387
DigiVis: Self-testing Vision App for Telephone Consultations
DigiVis: Validation of Self-testing Visual Acuity Web-based App to Aid Ophthalmic Telephone Consultations During Covid19 Lockdown and Subsequent Social Distancing Crisis
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Louise E Allen, MBBS MD
- Phone Number: 07941666981
- Email: louise@louiseallen.com
Study Contact Backup
- Name: Nabil Uddin
- Email: nabil.uddin@addenbrookes.nhs.uk
Study Locations
-
-
Cambs
-
Cambridge, Cambs, United Kingdom, CB2 0QQ
- Recruiting
- Cambridge University Hospitals NHS Trust
-
Contact:
- Nabil Uddin
- Email: nabil.uddin@addenbrookes.nhs.uk
-
Contact:
- Louise Allen
- Phone Number: 07941666981
- Email: louise@louiseallen.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: subjects recruited to visual acuity testing
All recruited subjects will have the intervention (Digivis visual acuity self-testing) and the standard clinical visual acuity assessment in clinic.
|
Self-testing of visual acuity app on two occasions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of visual acuity measurement using DigiVis testing and standard visual acuity testing
Time Frame: within 30 days
|
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
Time Frame: within 30 days
|
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
Time Frame: within 30 days
|
Measurement of test-retest variability
|
within 30 days
|
Collaborators and Investigators
Investigators
- Study Director: Stephen E Kelleher, Cambridge University Hospitals NHS Foundation Trust
Publications and helpful links
General 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. Erratum In: Lancet Glob Health. 2018 Oct;6(10):e1072.
- 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. Erratum In: JAMA Ophthalmol. 2015 Sep;133(9):1096.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS196573
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Visual Impairment
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; University Ghent; Research Foundation Flanders; Free University of Brussels and other collaboratorsUnknowniVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment (iVision)Visual Perceptual Weakness (Disorder) | Cerebral Visual ImpairmentBelgium
-
Novartis PharmaceuticalsCompletedNeovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNVGermany
-
Universitaire Ziekenhuizen KU LeuvenVrije Universiteit Brussel; Fund for Scientific Research, Flanders, BelgiumRecruitingCerebral Visual ImpairmentBelgium
-
Russell L. WoodsResearch to Prevent Blindness / Lions Club International FoundationNot yet recruitingCentral Visual Impairment
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Clinique Rive GaucheCompletedVisual Impairment in ChildrenFrance
-
Nantes University HospitalTerminatedCentral or Peripheral Visual ImpairmentFrance
-
VA Office of Research and DevelopmentCompletedScotoma, Central | Central Visual ImpairmentUnited States
-
University Health Network, TorontoNot yet recruitingStroke | Cognitive Impairment | Virtual Reality | Visual Impairment | Low Vision | Driving Impaired | Visual Spatial Processing | Visual Processing Speed | Visual Field DefectCanada
Clinical Trials on DigiVis visual acuity app
-
EyeQue Corp.Eye Boutique OptometryCompleted
-
University of MichiganNational Eye Institute (NEI)Recruiting
-
Fondation Ophtalmologique Adolphe de RothschildRecruiting
-
Moorfields Eye Hospital NHS Foundation TrustKing's College London; Cardiff University; University College, London; Newcastle... and other collaboratorsRecruiting
-
Democritus University of ThraceCompletedRefractive Errors | Vision Disorders | Visual Acuity | Low VisionGreece
-
Berkeley Eye CenterCompletedPseudophakiaUnited States
-
DAVID HAUSERUnknown
-
Centre Hospitalier Universitaire DijonRecruitingSurgery for Cataract | Surgery for and Idiopathic Epiretinal MembraneFrance
-
Kubota Vision Inc.CompletedAge Related Macular DegenerationUnited States
-
Fondation Ophtalmologique Adolphe de RothschildRecruitingHereditary Retinal DystrophiesFrance