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

Amblyopia Clinical Trial

Official title:

Five Years of Eye Screening for Amblyopia Risk Factors in Children Aged <3 Years in Flanders: Epidemiological Retrospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05612568
• Other study ID #: S64110
• Status: Active, not recruiting
• Start date: September 1, 2022
• Est. completion date: September 2023

Study information

• Verified date: November 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this research we 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.

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.

Our aim is to analyze the distribution and evolution of refractive errors in children under the age of 3 years in Flanders. We suppose 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 us insight in the significance of the myopia epidemic in Flanders.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250000
• Est. completion date: September 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Months to 31 Months

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refractive error per eye	Sphere, cylinder, spherical equivalent	during single-visit screening
Primary	Difference in refractive error between both eyes	Sphere OD-OS, cylinder OD-OS, spherical equivalent OD-OS	during single-visit screening