AmblyopiaNCT05313516
OKKO Space Academy to Check Children's Vision at Home
A study testing OKKO Health app in people with Amblyopia, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment. There are three objectives to this work: 1. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- OKKO Health app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jun 2022to 30 Jun 2024
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3.01 - 8.99 years with amblyopia
- Currently undergoing or at first visit to start amblyopia patching treatment
- Vision is fully corrected in glasses
- Visual acuity between -0.02 and 0.98 logMAR
- Have daily access to an approved smartphone or tablet
- Parent/child able to read and understand English
- Patient (child) able to understand spoken English
Who cannot join
- Parent not able to read and understand English
- Patient (child) not able to understand spoken English
- Parent/child not willing to participate
- Parent unable to give consent
- Any other ocular comorbidities
- Child has cognitive impairment or intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OKKO Space Academy App: Families Checking Their Child's Vision at Home During Amblyopia Treatment
The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment.
There are three objectives to this work:
- Determine the feasibility of the OKKO Space Academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement).
- Assess the variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict improvements in visual acuity?)
- Explore agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.
- Conditions
- Amblyopia
- Being tested
- OKKO Health app
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKKO Health appDevice
Use of OKKO Health app for home monitoring.
| Study group | Role | What they receive |
|---|---|---|
| OKKO Health app | Experimental | Use of OKKO Health app for home monitoring. Receives: Device: OKKO Health app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of home monitoring using the OKKO Health app
The feasibility and acceptability of the OKKO Space Academy app for use between clinic visits from the child's and family perspective. This will be assessed through a purpose built questionnaire.
Measured: 3 months
Engagement of home monitoring using the OKKO Health app
The rate of engagement with the OKKO Space Academy app for use between clinic visits by the child (patient) and the family.
Measured: 3 months
Variability in app data.
The variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict changes in visual acuity?)
Measured: 3 months
Visual acuity
Exploring the agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start26 Jun 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313516
- Sponsor's protocol ID
- DALA1052
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OKKO Space Academy App: Families Checking Their Child's Vision at Home During Amblyopia Treatment
- ClinicalTrials.gov ID
- NCT05313516
- Acronym / sponsor ID
- DALA1052
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 Apr 2022 (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.
The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment.
There are three objectives to this work:
- Determine the feasibility of the OKKO Space Academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement).
- Assess the variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict improvements in visual acuity?)
- Explore agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OKKO Health app | Experimental | Device: OKKO Health appUse of OKKO Health app for home monitoring. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 3.01 - 8.99 years with amblyopia
- Currently undergoing or at first visit to start amblyopia patching treatment
- Vision is fully corrected in glasses
- Visual acuity between -0.02 and 0.98 logMAR
- Have daily access to an approved smartphone or tablet
Key exclusion criteria (6 listed)
- Parent not able to read and understand English
- Patient (child) not able to understand spoken English
- Parent/child not willing to participate
- Parent unable to give consent
- Any other ocular comorbidities
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 |
|---|---|---|
| OKKO Health appUse of OKKO Health app for home monitoring. | Device | OKKO Health app |
Primary outcome
Feasibility and acceptability of home monitoring using the OKKO Health app
Time frame: 3 months
The feasibility and acceptability of the OKKO Space Academy app for use between clinic visits from the child's and family perspective. This will be assessed through a purpose built questionnaire.
Engagement of home monitoring using the OKKO Health app
Time frame: 3 months
The rate of engagement with the OKKO Space Academy app for use between clinic visits by the child (patient) and the family.
Variability in app data.
Time frame: 3 months
The variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict changes in visual acuity?)
Visual acuity
Time frame: 3 months
Exploring the agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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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 OKKO Health app in people with Amblyopia, run by Moorfields Eye Hospital 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. 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?
Results are not available in the source record.
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?
Feasibility and acceptability of home monitoring using the OKKO Health app (time frame: 3 months). The study lists 4 primary outcomes in all. 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 1 Dec 2023.