OKKO Space Academy to Check Children's Vision at Home

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05313516
• Other study ID #: DALA1052
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 26, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• OKKO Health app
Use of OKKO Health app for home monitoring.

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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