Next Generation Home Vision Assessment

NCT ID: NCT06428435

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Amblyopia Vision; Low, One Eye (Other Eye Normal) Pediatric Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Ibis

Tested with Ibis technology

Vision Test

Intervention Type DIAGNOSTIC_TEST

Remote vision testing via digital screen

Optonet

Tested with Optonet Technology

Vision Test

Intervention Type DIAGNOSTIC_TEST

Remote vision testing via digital screen

Interventions

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Vision Test

Remote vision testing via digital screen

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

0 Months

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Birmingham Children's Hospital

OTHER

Sponsor Role collaborator

NHS Fife

OTHER_GOV

Sponsor Role collaborator

NHS Highland

OTHER

Sponsor Role collaborator

NHS Forth Valley

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iain Livingstone, MBChB MD

Role: PRINCIPAL_INVESTIGATOR

NHS Forth Valley

Locations

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Birmingham Womens and Childens Hospital

Birmingham, Birmingham, United Kingdom

Site Status

NHS Fife

Inverness, Inverness, United Kingdom

Site Status

NHS Forth Valley Research & Development Office

Falkirk, Stirlingshire, United Kingdom

Site Status

NHS Greater Glasgow & Clyde

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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286078

Identifier Type: OTHER

Identifier Source: secondary_id

20/WM/0285

Identifier Type: OTHER

Identifier Source: secondary_id

136640

Identifier Type: OTHER

Identifier Source: secondary_id

FV1275

Identifier Type: -

Identifier Source: org_study_id

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