OKKO Space Academy to Check Children's Vision at Home

November 30, 2023 updated by: Moorfields Eye Hospital NHS Foundation Trust

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 5 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OKKO Health app
Use of OKKO Health app for home monitoring.
Device: OKKO Health app
Use of OKKO Health app for home monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability of home monitoring using the OKKO Health app
Time Frame: 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.
3 months
Engagement of home monitoring using the OKKO Health app
Time Frame: 3 months
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.
Time Frame: 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?)
3 months
Visual acuity
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2022

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DALA1052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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