OKKO Space Academy to Check Children's Vision at Home

Moorfields Eye Hospital NHS Foundation Trust

Status: Invitation-only

Conditions: Amblyopia

Treatments: Device: OKKO Health app

Study type: Interventional

Funder types: Other

Identifiers

NCT05313516

DALA1052

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

OKKO Health app

Experimental group

Description:

Use of OKKO Health app for home monitoring.

Treatment:

Device: OKKO Health app