Clinical trial NCT06428435: Next Generation Home Vision Assessment
Official title: Next Generation Home Vision Assessment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Amblyopia
Vision; Low, One Eye (Other Eye Normal)
Pediatric Disorder
Keywords: teleophthalmology
remote consultations
amblyopia
paediatrics
telemedicine
digital health
Lead sponsor: NHS Forth Valley
Sponsor class: OTHER_GOV
Collaborators: name: NHS Greater Glasgow and Clyde
name: Birmingham Children's Hospital
name: NHS Fife
name: NHS Highland
First posted: 2024-05-24
Enrollment: 360
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending hospital and at home

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acuity
timeFrame: 2 weeks
Secondary outcomes:
measure: Colour Vision
timeFrame: 2 weeks
measure: Visual field
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Falkirk
country: United Kingdom
facility: NHS Forth Valley Research & Development Office
state: Stirlingshire
city: Birmingham
country: United Kingdom
facility: Birmingham Womens and Childens Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow & Clyde
city: Inverness
country: United Kingdom
facility: NHS Fife
Study officials:
affiliation: NHS Forth Valley
name: Iain Livingstone, MBChB MD
role: PRINCIPAL_INVESTIGATOR
References: