NCT06980415

Brief Summary

Repeated measures observational study of tablet-based children's visual acuity tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2023

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
Last Updated

May 20, 2025

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

September 1, 2023

Last Update Submit

May 19, 2025

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Visual acuity collected using the Kay Pictures iSight iPad application in the hands of the parent or carer on Day 0 of the study (cross sectional design).

    Participants complete the primary outcome variable measurements on Day 0 of study recruitment.

Study Arms (1)

Visual acuity test

EXPERIMENTAL
Device: Kay Pictures iSight

Interventions

Kay Pictures iSightDEVICE

Tablet-based visual acuity measurement

Visual acuity test

Eligibility Criteria

Age0 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age under 10 years
  • Able to complete a subjective visual acuity test

You may not qualify if:

  • Parent or carer not willing to participate in the study and give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

September 1, 2023

First Posted

May 20, 2025

Study Start

July 6, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 20, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

IPD available upon request to Daniel Osborne (d.osborne@soton.ac.uk)

Locations

GB(1)