OKKO Space Academy to Check Children's Vision at Home

NCT05313516 | Unknown

• 1 other identifier: DALA1052
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

OKKO Health app

EXPERIMENTAL

Use of OKKO Health app for home monitoring.

Device: OKKO Health app

Interventions

OKKO Health app DEVICE

Use of OKKO Health app for home monitoring.

OKKO Health app

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: April 6, 2022
• Study Start: June 26, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

GB (1)