NCT06428435

Brief Summary

Comparison of live remote paediatric digital vision testing outcomes versus face to face appointments in orthoptic clinic

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

May 20, 2024

Last Update Submit

July 15, 2025

Conditions

Keywords

teleophthalmologyremote consultationsamblyopiapaediatricstelemedicinedigital health

Outcome Measures

Primary Outcomes (1)

  • Acuity

    Home versus Remote Acuity difference

    2 weeks

Secondary Outcomes (2)

  • Colour Vision

    2 weeks

  • Visual field

    2 weeks

Study Arms (2)

Ibis

Tested with Ibis technology

Diagnostic Test: Vision Test

Optonet

Tested with Optonet Technology

Diagnostic Test: Vision Test

Interventions

Vision TestDIAGNOSTIC_TEST

Remote vision testing via digital screen

IbisOptonet

Eligibility Criteria

Age0 Months - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending hospital and at home

You may qualify if:

  • \- Patients attending hospital eye services will be eligible for enrolment.
  • Age: less than 90 years old English speakers, as no available resource for translation services. Parents / patients must be able to provide consent Patient must be able to communicate what he / she sees on a vision assessment chart.
  • Must have access to smartphone, tablet or home computer that can run video conferencing platforms.

You may not qualify if:

  • Non English speakers or lack of ability to consent Inability to communicate what is seen on a chart, or inability to complete a preferential looking visual acuity test Inability to connect to a video conferencing platform.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Birmingham Womens and Childens Hospital

Birmingham, Birmingham, B4 6NH, United Kingdom

Location

NHS Fife

Inverness, Inverness, IV2 3JH, United Kingdom

Location

NHS Forth Valley Research & Development Office

Falkirk, Stirlingshire, FK1 5SU, United Kingdom

Location

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Amblyopia

Interventions

Vision Tests

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Iain Livingstone, MBChB MD

    NHS Forth Valley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 24, 2024

Study Start

March 1, 2023

Primary Completion

August 31, 2024

Study Completion

December 31, 2024

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Anonymised data will be made available as part of publication

Time Frame
Aim: 12 months post completion of study
Access Criteria
Open Access

Locations