DigiVis: Self-testing Vision App for Telephone Consultations

NCT04482387 | Completed Results

• 1 other identifier: IRAS196573
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Visual Impairment; Amblyopia Suspect

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Mean Bias Between Repeated DigiVis Test Assessments

  within 30 days

Study Arms (1)

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.

Device: DigiVis visual acuity app

Interventions

DigiVis visual acuity app DEVICE

Self-testing of visual acuity app on two occasions

Subjects recruited to visual acuity testing

Eligibility Criteria

• Age: 5 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 5 and 85 years
• Previous recorded visual acuity of at least +0.8 logMAR in or both eyes

You may not qualify if:

• Individuals with poor conversant English
• Individuals with cognitive impairment
• Subjects unable to access the internet on two digital devices

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge University Hospitals NHS Trust

Cambridge, Cambs, CB2 0QQ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 30012273 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.

  PMID: 26022921 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.

  PMID: 34462579 BACKGROUND

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study recruited a smaller number of participants than originally intended but 120 participants was sufficient to enable narrow 95% confidence limits.

Results Point of Contact

• Title: Stephen Kelleher
• Organization: Cambridge University Hospitals NHS Foundation Trust

research@addenbrookes.nhs.uk

01223217418

Study Officials

• Stephen E Kelleher

  Cambridge University Hospitals NHS Foundation Trust

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 22, 2020
• Study Start: July 24, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 5, 2024
• Results First Posted: August 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)