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OKKO Space Academy to Check Children's Vision at Home

Primary Purpose

Amblyopia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
OKKO Health app
Sponsored by
Moorfields Eye Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Amblyopia

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OKKO Health app

Arm Description

Use of OKKO Health app for home monitoring.

Outcomes

Primary Outcome Measures

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.
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.
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?)
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.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2021
Last Updated
July 21, 2022
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05313516
Brief Title
OKKO Space Academy to Check Children's Vision at Home
Official Title
OKKO Space Academy App: Families Checking Their Child's Vision at Home During Amblyopia Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 26, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moorfields Eye Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OKKO Health app
Arm Type
Experimental
Arm Description
Use of OKKO Health app for home monitoring.
Intervention Type
Device
Intervention Name(s)
OKKO Health app
Intervention Description
Use of OKKO Health app for home monitoring.
Primary Outcome Measure Information:
Title
Feasibility and acceptability of home monitoring using the OKKO Health app
Description
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.
Time Frame
3 months
Title
Engagement of home monitoring using the OKKO Health app
Description
The rate of engagement with the OKKO Space Academy app for use between clinic visits by the child (patient) and the family.
Time Frame
3 months
Title
Variability in app data.
Description
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?)
Time Frame
3 months
Title
Visual acuity
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Moorfields Eye Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

OKKO Space Academy to Check Children's Vision at Home

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