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OKKO Space Academy to Check Children's Vision at Home

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05313516
Enrollment
100
Registered
2022-04-06
Start date
2022-06-26
Completion date
2024-06-30
Last updated
2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Brief 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. 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). 2. 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?) 3. 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.

Interventions

Use of OKKO Health app for home monitoring.

Sponsors

Moorfields Eye Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and acceptability of home monitoring using the OKKO Health app3 monthsThe 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 app3 monthsThe 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.3 monthsThe 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 acuity3 monthsExploring 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026