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OpenTrials
Active, Not Recruiting

NCT Number: NCT05484453

Validation of the GoCheck Kids® Eye Screeningtest in Infants 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Infant Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

11 month–16 month

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complete Eye Examination by Ophthalmologist

Diagnostic Test

complete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

Primary outcomes

  1. Sensitivity

    Time frame: Day 1

    Sensitivity of GCK eye screener

  2. Specificity

    Time frame: Day 1

    Specificity of GCK eye screener

  3. Positive predictive value

    Time frame: Day 1

    Positive predictive value of GCK eye screener

  4. Negative predictive value

    Time frame: Day 1

    Negative predictive value of GCK eye screener

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Aug 2, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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