5 Years of Eye Screening for ARF in Children Aged <3 Years in Flanders

Active, not recruiting

• Conditions: Amblyopia

• Registration Number: NCT05612568
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Researchers will investigate the distribution and evolution of amblyopia risk factors and other refractive errors in children younger than 3 years of age. The significance and magnitude of current global evolutions in ARF and refractive errors will be verified to update current guidelines and practices. Better insight in associated factors of amblyopia risk factors will contribute to current understanding of amblyopia.

Detailed Description

The eye screening program of the Flemish governmental agency 'Kind en Gezin' is a well-implemented screening program for detection of ARF in children under the age of 3 years. This screening covers almost 85% of all children born in the Flemish community. Valuable information about distribution and determinants of refractive errors and ARF are collected at 'Kind en Gezin', but remain unstudied until today.

The aim is to analyze the distribution and evolution of refractive errors in children under the age of 3 years in Flanders. One supposes that identification of patterns in this distribution, and identification of determinants that influence ARF, will lead to improved knowledge about amblyopia (risk factors) and on their turn help optimize the ARF screening program. Evaluation of the distribution and evolution of refractive errors over time, and comparison with global results, will also give researchers insight in the significance of the myopia epidemic in Flanders.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250000

Inclusion Criteria

• We include all children with a PlusOptix screening between 2013 and 2018 with the age of 12±1 months or 30±1 months. Children who were screened twice, can be included twice with both screening results.

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Refractive error per eye	Day 1	Sphere, cylinder, spherical equivalent
Difference in refractive error between both eyes	Day 1	Sphere OD-OS, cylinder OD-OS, spherical equivalent OD-OS

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium