Trial Outcomes & Findings for DigiVis: Self-testing Vision App for Telephone Consultations (NCT NCT04482387)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

within 30 days

Results posted on

2024-08-05

Participant Flow

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.

All participants underwent both the DigiVis testing and the standard clinical visual acuity test.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	All Study Participants Right eye data for all 120 participants to the study.
Overall Study STARTED	120 120
Overall Study COMPLETED	120 120
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=120 Participants Right eye data for all 120 participants to the study.
Age, Customized Age category · 5-10 years	44 Participants n=120 Participants
Age, Customized Age category · 11-54 years	37 Participants n=120 Participants
Age, Customized Age category · 55 - 75 years	32 Participants n=120 Participants
Age, Customized Age category · 76-85	7 Participants n=120 Participants
Sex: Female, Male Female	66 Participants n=120 Participants
Sex: Female, Male Male	54 Participants n=120 Participants

PRIMARY outcome

Timeframe: within 30 days

Population: All participants had their right eye tested firstly with the standard chart technique and subsequently with DigiVis

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).

Outcome measures

Outcome measures
Measure	Standard Vision Testing n=120 Participants Participants had standard chart testing of their right eye.	DigiVis Vision Testing n=120 Participants The same cohort of patients then had DigiVis vision testing
Mean Bias Between the Difference Between DigiVis and Standard Visual Assessment Compared to the Mean of DigiVis and Standard Visual Assessment	0.112 logMAR Standard Deviation 0.247	0.100 logMAR Standard Deviation 0.270

SECONDARY outcome

Timeframe: within 30 days

Population: Participants able to undertake DigiVis testing twice to analyse test repeatability

Mean bias between the difference of two DigiVis visual acuity assessments compared to the mean of two digiVis assessments measured in logMAR units.

Outcome measures

Outcome measures
Measure	Standard Vision Testing n=105 Participants Participants had standard chart testing of their right eye.	DigiVis Vision Testing n=105 Participants The same cohort of patients then had DigiVis vision testing
Mean Bias Between Repeated DigiVis Test Assessments	0.100 logMAR Standard Deviation 0.270	0.105 logMAR Standard Deviation 0.258

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen Kelleher

Cambridge University Hospitals NHS Foundation Trust

Phone: 01223217418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place