Validation of the GoCheck Kids® Eye Screeningtest in Infants in Flanders

August 8, 2022 updated by: Universitaire Ziekenhuizen KU Leuven

Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.

The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Comparison of the results of the GoCheck Kids application on iPhone with a complete eye examination (gold standard) including cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

Study Type

Observational

Enrollment (Anticipated)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 months to 1 year (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children who undergo GCK evaluation at the Child And Family Agency consultation

Description

Inclusion Criteria:

  • GoCheck Kids (GCK) evaluation at Child and Family Agency at the age between 11-16 months.

Exclusion Criteria:

  • Allergy for the used cycloplegia cyclopentolate 0.5%.
  • Any history of ocular surgery
  • The time window between GCK measurement and the complete eye examination may not exceed 2 months.
  • The parents or legal representatives of the child do not understand or speak Dutch, French or English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GoCheckKids screening
GoCheckKids screening at the Child And Family Agency at the age of 12-15 months (+- 1 month) are invited to undergo a complete eye examination by an ophthalmologist for evaluation of amblyopia risk factors.
Diagnostic test: Complete Eye Examination by Ophthalmologist
complete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Day 1
Sensitivity of GCK eye screener
Day 1
Specificity
Time Frame: Day 1
Specificity of GCK eye screener
Day 1
Positive predictive value
Time Frame: Day 1
Positive predictive value of GCK eye screener
Day 1
Negative predictive value
Time Frame: Day 1
Negative predictive value of GCK eye screener
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Catherine Cassiman, MD, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S64113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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