OKKO Space Academy to Check Children's Vision at Home

Not Applicable

• Conditions: Amblyopia
• Interventions: Device: OKKO Health app

• Registration Number: NCT05313516
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-06
• Study Start: 2022-06-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OKKO Health app	OKKO Health app	Use of OKKO Health app for home monitoring.

Primary Outcome Measures

Name	Time	Method
Variability in app data.	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?)
Feasibility and acceptability of home monitoring using the OKKO Health app	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	3 months	The rate of engagement with the OKKO Space Academy app for use between clinic visits by the child (patient) and the family.
Visual acuity	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.

Trial Locations

Locations (1)

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom