Next Generation Home Vision Assessment (NGHVA)

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

Study Overview

• Status: Completed
• Conditions: Amblyopia; Pediatric Disorder; Vision; Low, One Eye (Other Eye Normal)
• Intervention / Treatment: Diagnostic test: Vision Test

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Womens and Childens Hospital
  • Glasgow, United Kingdom
    • NHS Greater Glasgow & Clyde
  • Inverness, United Kingdom, IV2 3JH
    • NHS Fife
  • Stirlingshire
    • Falkirk, Stirlingshire, United Kingdom, FK1 5SU
      • NHS Forth Valley Research & Development Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients attending hospital and at home

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ibis; Tested with Ibis technology	Diagnostic test: Vision Test; Remote vision testing via digital screen
Optonet; Tested with Optonet Technology	Diagnostic test: Vision Test; Remote vision testing via digital screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acuity	Home versus Remote Acuity difference	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colour Vision	Digital versus in clinic standard	2 weeks
Visual field	Digital versus in clinic standard	2 weeks

Collaborators and Investigators

• Sponsor: NHS Forth Valley
• Collaborators: NHS Fife; Birmingham Children's Hospital; NHS Highland
• Investigators: Principal Investigator: Iain Livingstone, MBChB MD, NHS Forth Valley

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: telemedicine; digital health; amblyopia; paediatrics; teleophthalmology; remote consultations
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Amblyopia
• Other Study ID Numbers: FV1275; 136640 (Other Identifier: Edge ID); 286078 (Other Identifier: IRAS Project ID); 20/WM/0285 (Other Identifier: REC Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be made available as part of publication
• IPD Sharing Time Frame: Aim: 12 months post completion of study
• IPD Sharing Access Criteria: Open Access

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No