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OpenTrials
Completed

NCT Number: NCT06428435

Next Generation Home Vision Assessment

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

Completed

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Key information

Age range

0 month–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham Womens and Childens Hospital, Birmingham, United Kingdom

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About this study

Study Overview The "Next Generation Home Vision Assessment" study aims to evaluate the feasibility and accuracy of conducting vision assessments at home using a web-based platform. This prospective, non-interventional, multi-center study will compare home-based vision tests with traditional hospital-based assessments.

Study Background The COVID-19 pandemic has significantly limited patients' ability to attend in-person eye clinic appointments, impacting vision assessments and management. Ramifications in delays continue to have an impact.

Study Rationale This study seeks to validate home-based vision assessments against standard in-person evaluations to ensure patients can be effectively monitored and managed remotely. The use of a web-based platform for vision tests could offer a reliable alternative, reducing hospital visits and maintaining care standards.

Objectives and Endpoints Primary Objective: To compare the accuracy of home-based visual acuity tests to hospital-based assessments.

Secondary Objectives: To evaluate other aspects of visual function (e.g., visual fields, color vision, contrast sensitivity) and measure patient engagement and test duration.

Study Design Type: Prospective, non-interventional Participants: Adults and children attending hospital eye services Sample Size: 360 completed assessments Duration: Minimum of 6 months

Study Procedure Participants attending hospital eye services will be recruited and provided with a patient information leaflet. Those willing to participate will undergo a visual acuity test +/- additional vision tests (secondary outcomes) during a video consultation. Hospital-based assessment results will be compared to home-based test results to determine accuracy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

Vision Test

Diagnostic Test

Remote vision testing via digital screen

Primary outcomes

  1. Acuity

    Time frame: 2 weeks

    Home versus Remote Acuity difference

Secondary outcomes

  1. Colour Vision

    Time frame: 2 weeks

    Digital versus in clinic standard

  2. Visual field

    Time frame: 2 weeks

    Digital versus in clinic standard

Sponsors and collaborators

Lead sponsor

NHS Forth Valley

Other Gov

Collaborators

  • Birmingham Children's Hospital
  • NHS Fife
  • NHS Highland

Registry information

Acronym: NGHVA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 24, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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