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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05313516
Other study ID # DALA1052
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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