Enrolling by invitationNCT05313516Updated Dec 1, 2023

OKKO Space Academy to Check Children's Vision at Home

An interventional study of OKKO Health app in Amblyopia, sponsored by Moorfields Eye Hospital NHS Foundation Trust. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 3 Years to 9 Years. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by Moorfields Eye Hospital NHS Foundation Trust · Not applicable, Interventional, and Other

From the registry’s dates

Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as enrolling by invitation.

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Not applicable
Ages: 3 Years to 9 Years
Sex: All

Study 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:

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).
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?)
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 studied

Amblyopia

Browse trials for

Amblyopia 189

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 137 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years to 9 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
OKKO Health app
Use of OKKO Health app for home monitoring.
Device: OKKO Health app

Interventions

DeviceOKKO Health app
Use of OKKO Health app for home monitoring.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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?)
Time frame: 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.
Time frame: 3 months

Study locations

1 site

Moorfields Eye Hospital
London, United Kingdom
17 other open studies at this site →

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for Mar 2024, 21 months after the start.

Of 58 non-industry interventional studies with no phase under Amblyopia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 72. This study's planned 21 months is below that.

Counting every sponsor, half of 71 studies reached it within 33 months; a quarter within 17 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 1, 2021
First posted: Apr 6, 2022
StartActual: Jun 26, 2022
Primary completionEst.: Mar 31, 2024
CompletionEst.: Jun 30, 2024
Last update: Dec 1, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05313516
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Responsible party: Sponsor
First posted: Apr 6, 2022
Start date: Jun 26, 2022
Primary completion: Mar 31, 2024 (estimated)
Completion: Jun 30, 2024 (estimated)
Last update: Dec 1, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Amblyopia →

Other studies from this sponsor

Moorfields Eye Hospital NHS Foundation Trust

Start the discussion