AmblyopiaCHEETAHNCT06980415
Children's Eye Examination and Testing At Home Study
A study testing Kay Pictures iSight in people with Amblyopia, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Repeated measures observational study of tablet-based children's visual acuity tests. Read more about this study
- Who is it for?
- Ages 0 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Kay Pictures iSight
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2020to 31 Dec 2021
- Phase
- Interventional
- 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 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age under 10 years
- Able to complete a subjective visual acuity test
Who cannot join
- Parent or carer not willing to participate in the study and give written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
About this study
Official title: Testing Children's Visual Acuity at Home: The Feasibility of a Home-based Visual Acuity Test to Improve Outcomes From Patching for Amblyopia.
Repeated measures observational study of tablet-based children's visual acuity tests.
Read the detailed description
The most common disease seen in paediatric eye clinics is lazy eye (amblyopia), which affects 5% of the population. Amblyopia is treated using eye patching or eye drop therapy over the course of 6 months to two years. Up to half of all children undergoing therapy for amblyopia do not achieve a successful outcome. The outcome measure (visual acuity) is how small a letter the patient can see on a Snellen-like chart. Visual acuity is measured six-weekly for amblyopia patients in the outpatient clinic and is used to decide when to start therapy and how much therapy to use.
Recent developments by visual acuity test manufacturers of iPAD-based tests have simplified the testing protocol so that it may be performed by untrained staff. It is currently not understood to what level of accuracy a lay-person can perform the test. The present study was conceived to answer questions brought to us by patients and their parents, whom reported in our PPI activities that they feel they could use the iPAD themselves to test visual acuity.
This study is designed to quantify the correlation between iPAD-based visual acuity measurements taken by lay persons and the gold-standard, clinic-based measurements taken by qualified orthoptists using standard of care equipment and protocols. Collaboration between the PPI group and researchers expect that the correlation will likely be high and the teams anticipate possible advantages to lay-persons testing the visual acuity including, fewer visits to hospital and better adherence to amblyopia therapy.
Home visual acuity test has potential to reduce the number of outpatient clinic assessments or allow assessment of patients that could not be assessed during the UK coronavirus epidemic. However, the awarding body, BIOS, have requested that orthoptists do not instruct patients to use home-based visual acuity tests as the procedure is not covered by indemnity insurance. BIOS reference a lack of evidence-base. The new aim of the study will be to determine the validity of home-based visual acuity assessments with the possibility of providing such an evidence- base.
The study aim will be achieved by measuring the visual acuity in the outpatient clinic as per standard of care and asking the parent or carer to use the iPAD to test visual acuity at the same visit
- Conditions
- Amblyopia
- Being tested
- Kay Pictures iSight
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kay Pictures iSightDevice
Tablet-based visual acuity measurement
| Study group | Role | What they receive |
|---|---|---|
| Visual acuity test | Experimental | Not described Receives: Device: Kay Pictures iSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Visual acuity collected using the Kay Pictures iSight iPad application in the hands of the parent or carer on Day 0 of the study (cross sectional design).
Measured: Participants complete the primary outcome variable measurements on Day 0 of study recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start6 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980415
- Sponsor's protocol ID
- RHM OPH0285
- Acronym
- CHEETAH
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD available upon request to Daniel Osborne (d.osborne@soton.ac.uk)
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Children's Visual Acuity at Home: The Feasibility of a Home-based Visual Acuity Test to Improve Outcomes From Patching for Amblyopia.
- ClinicalTrials.gov ID
- NCT06980415
- Acronym / sponsor ID
- CHEETAH / RHM OPH0285
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 May 2025 (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.
Repeated measures observational study of tablet-based children's visual acuity tests.
Detailed description
The most common disease seen in paediatric eye clinics is lazy eye (amblyopia), which affects 5% of the population. Amblyopia is treated using eye patching or eye drop therapy over the course of 6 months to two years. Up to half of all children undergoing therapy for amblyopia do not achieve a successful outcome. The outcome measure (visual acuity) is how small a letter the patient can see on a Snellen-like chart. Visual acuity is measured six-weekly for amblyopia patients in the outpatient clinic and is used to decide when to start therapy and how much therapy to use.
Recent developments by visual acuity test manufacturers of iPAD-based tests have simplified the testing protocol so that it may be performed by untrained staff. It is currently not understood to what level of accuracy a lay-person can perform the test. The present study was conceived to answer questions brought to us by patients and their parents, whom reported in our PPI activities that they feel they could use the iPAD themselves to test visual acuity.
This study is designed to quantify the correlation between iPAD-based visual acuity measurements taken by lay persons and the gold-standard, clinic-based measurements taken by qualified orthoptists using standard of care equipment and protocols. Collaboration between the PPI group and researchers expect that the correlation will likely be high and the teams anticipate possible advantages to lay-persons testing the visual acuity including, fewer visits to hospital and better adherence to amblyopia therapy.
Home visual acuity test has potential to reduce the number of outpatient clinic assessments or allow assessment of patients that could not be assessed during the UK coronavirus epidemic. However, the awarding body, BIOS, have requested that orthoptists do not instruct patients to use home-based visual acuity tests as the procedure is not covered by indemnity insurance. BIOS reference a lack of evidence-base. The new aim of the study will be to determine the validity of home-based visual acuity assessments with the possibility of providing such an evidence- base.
The study aim will be achieved by measuring the visual acuity in the outpatient clinic as per standard of care and asking the parent or carer to use the iPAD to test visual acuity at the same visit
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual acuity test | Experimental | Device: Kay Pictures iSight |
Who may qualify
- Ages
- 0 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age under 10 years
- Able to complete a subjective visual acuity test
Key exclusion criteria (1 listed)
- Parent or carer not willing to participate in the study and give written informed consent
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 |
|---|---|---|
| Kay Pictures iSightTablet-based visual acuity measurement | Device | Visual acuity test |
Primary outcome
Visual acuity
Time frame: Participants complete the primary outcome variable measurements on Day 0 of study recruitment.
Visual acuity collected using the Kay Pictures iSight iPad application in the hands of the parent or carer on Day 0 of the study (cross sectional design).
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 20 May 2025.
- Individual participant dataSharing planned: No. IPD available upon request to Daniel Osborne (d.osborne@soton.ac.uk)
Related trials for Amblyopia
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Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kay Pictures iSight in people with Amblyopia, run by University Hospital Southampton NHS Foundation Trust at 1 site 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 2 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 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Visual acuity (time frame: Participants complete the primary outcome variable measurements on Day 0 of study recruitment.). 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 20 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.