OKKO Space Academy to Check Children's Vision at Home

Study Overview
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Brief Summary
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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.

Official Title
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OKKO Space Academy App: Families Checking Their Child's Vision at Home During Amblyopia Treatment

Conditions
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Amblyopia

Intervention / Treatment
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* Device: OKKO Health app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OKKO Health app<br>Use of OKKO Health app for home monitoring. | Device: OKKO Health app<br>* Use of OKKO Health app for home monitoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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?) | 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. | 3 months |