N/A N=120 Screening

DigiVis: Self-testing Vision App for Telephone Consultations

Visual Impairment · Amblyopia Suspect

Bottom Line

View on ClinicalTrials.gov: NCT04482387 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Mean Bias Between the Difference Between DigiVis and Standard Visual Assessment Compared to the Mean of DigiVis and Standard Visual Assessment — 0.112; 0.100 logMAR

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: DigiVis visual acuity app (Device)
Age: Pediatric, Adult, Older Adult · 5+ yrs
Sex: All
Sponsor: Cambridge University Hospitals NHS Foundation Trust
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Bias Between the Difference Between DigiVis and Standard Visual Assessment Compared to the Mean of DigiVis and Standard Visual Assessment	0.112; 0.100	—
SECONDARY Mean Bias Between Repeated DigiVis Test Assessments	0.100; 0.105	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04482387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.