Next Generation Home Vision Assessment

• Conditions: Amblyopia; Vision; Low, One Eye (Other Eye Normal); Pediatric Disorder
• Interventions: Diagnostic Test: Vision Test

• Registration Number: NCT06428435
• Lead Sponsor: NHS Forth Valley

Brief Summary

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

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 Timeline

• Study Start: 2023-03-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Optonet	Vision Test	Tested with Optonet Technology
Ibis	Vision Test	Tested with Ibis technology

Primary Outcome Measures

Name	Time	Method
Acuity	2 weeks	Home versus Remote Acuity difference

Secondary Outcome Measures

Name	Time	Method
Visual field	2 weeks	Digital versus in clinic standard
Colour Vision	2 weeks	Digital versus in clinic standard

Trial Locations

Locations (4)

NHS Forth Valley Research & Development Office; 🇬🇧 Falkirk, Stirlingshire, United Kingdom

NHS Greater Glasgow & Clyde; 🇬🇧 Glasgow, United Kingdom

Birmingham Womens and Childens Hospital; 🇬🇧 Birmingham, United Kingdom

NHS Fife; 🇬🇧 Inverness, United Kingdom