Next Generation Home Vision Assessment

Amblyopia Clinical Trial

— NGHVA  

Official title:

Next Generation Home Vision Assessment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06428435
• Other study ID #: 1.5
• Secondary ID: 28607820/WM/0285
• Status: Enrolling by invitation
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: NHS Forth Valley
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 360
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amblyopia
• Pediatric Disorder

Intervention

Diagnostic Test:
• Vision Test
Remote vision testing via digital screen

Locations

Country	Name	City	State
United Kingdom	Birmingham Womens and Childens Hospital	Birmingham
United Kingdom	NHS Forth Valley Research & Development Office	Falkirk	Stirlingshire
United Kingdom	NHS Greater Glasgow & Clyde	Glasgow
United Kingdom	NHS Fife	Inverness

Sponsors (5)

Lead Sponsor	Collaborator
NHS Forth Valley	Birmingham Children's Hospital, NHS Fife, NHS Greater Glasgow and Clyde, NHS Highland

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acuity	Home versus Remote Acuity difference	2 weeks
Secondary	Colour Vision	Digital versus in clinic standard	2 weeks
Secondary	Visual field	Digital versus in clinic standard	2 weeks