OKKO Space Academy to Check Children's Vision at Home

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05313516
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 7.2
• Patients Per Site Per Month: 13.8

Study Details

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Amblyopia	Device: OKKO Health app	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: OKKO Space Academy App: Families Checking Their Child's Vision at Home During Amblyopia Treatment
• Actual Study Start Date: Jun 26, 2022
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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?)

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moorfields Eye Hospital	London		United Kingdom

Sponsors and Collaborators

• Moorfields Eye Hospital NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT05313516
• Other Study ID Numbers: DALA1052
• First Posted: Apr 6, 2022
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Jul 26, 2022