AmblyopiaNGHVANCT06428435
Next Generation Home Vision Assessment
An observational study of Amblyopia and Vision; Low, One Eye (Other Eye Normal), run by NHS Forth Valley at 4 sites in United Kingdom.
Trial summary
Comparison of live remote paediatric digital vision testing outcomes versus face to face appointments in orthoptic clinic Read more about this study
- Who is it for?
- Ages 0 months to 90 years
- Conditions the study is for
- Amblyopia, Vision; Low, One Eye (Other Eye Normal), Pediatric Disorder
- What is being tested?
- Vision Test
- How many people
- 206 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients attending hospital and at home
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Birmingham Womens and Childens Hospital
Birmingham, Birmingham, B4 6NH
NHS Forth Valley Research & Development Office
Falkirk, Stirlingshire, FK1 5SU
NHS Greater Glasgow & Clyde
Glasgow
NHS Fife
Inverness, Inverness, IV2 3JH
About this study
Comparison of live remote paediatric digital vision testing outcomes versus face to face appointments in orthoptic clinic
Read the 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.
- Being tested
- Vision Test
- Keywords
- teleophthalmology, remote consultations, amblyopia, paediatrics, telemedicine, digital health
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision TestDiagnostic test
Remote vision testing via digital screen
| Study group | Role | What they receive |
|---|---|---|
| Ibis | Tested with Ibis technology Receives: Diagnostic Test: Vision Test | |
| Optonet | Tested with Optonet Technology Receives: Diagnostic Test: Vision Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acuity
Home versus Remote Acuity difference
Measured: 2 weeks
Secondary outcomes (2)
Colour Vision
Digital versus in clinic standard
Measured: 2 weeks
Visual field
Digital versus in clinic standard
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Mar 2023
- Primary completion31 Aug 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Forth Valley
- Sponsor type
- Other government
- Collaborators
- Birmingham Children's Hospital, NHS Fife, NHS Highland
- Responsible party
- Sponsor
- Investigators
- Iain Livingstone, MBChB MD, Principal investigator, NHS Forth Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428435
- Sponsor's protocol ID
- FV1275
- Other IDs
- 286078, 20/WM/0285, 136640
- Acronym
- NGHVA
- Status last verified
- Jul 2025
- First submitted
- 20 May 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be made available as part of publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation Home Vision Assessment
- ClinicalTrials.gov ID
- NCT06428435
- Acronym / sponsor ID
- NGHVA / FV1275
- Keywords
- teleophthalmology, remote consultations, amblyopia, paediatrics, telemedicine, digital health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- NHS Forth ValleyOther government
- Collaborators
- Birmingham Children's Hospital, NHS Fife, NHS Highland
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibis | – | Diagnostic Test: Vision TestTested with Ibis technology |
| Optonet | – | Diagnostic Test: Vision TestTested with Optonet Technology |
Who may qualify
- Ages
- 0 months to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending hospital and at home
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vision TestRemote vision testing via digital screen | Diagnostic test | Ibis, Optonet |
Primary outcome
Acuity
Time frame: 2 weeks
Home versus Remote Acuity difference
2 secondary outcomes
Colour Vision
Time frame: 2 weeks
Visual field
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. Anonymised data will be made available as part of publication
Related trials for Amblyopia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain Livingstone, MBChB MD principal investigator
NHS Forth Valley
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amblyopia and Vision; Low, One Eye (Other Eye Normal), run by NHS Forth Valley at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acuity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.