Vision Screening for the Detection of Amblyopia

Refractive Errors Clinical Trial

Official title:

Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430247
• Other study ID #: 30082011/2011
• Status: Completed
• Phase: N/A
• Start date: September 12, 2011
• Est. completion date: September 12, 2014

Study information

• Verified date: July 2019
• Source: General Hospital Sveti Duh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

INTRODUCTION. Amblyopia is defined as the loss of visual acuity (VA) in one or both eyes, without any obvious structural or pathological anomalies. Amblyopic eye should be able to regain some VA if treatment is initiated before the age of seven. It is the leading cause of monocular blindness in the 20- to 70-year olds with prevalence 2-5%. Amblyopia is mainly monocular, hence children are general asymptomatic. VA testing is the only reliable method of detecting amblyopia, and the fourth year of life is considered best for vision screening programs.

AIM: The purpose of the study is to reduce the preventable vision loss. The main goal of the study is to evidence the problem of amblyopia in Zagreb and to release a model for formal, government directed vision-screening program as a Croatian public health policy.

HYPOTHESIS. In Croatia, the prevalence and actual effect of amblyopia and amblyogenic factors, along with treatment efficacy is impossible to quantify, since no population-based studies have been performed regarding this issue. In addition, national screening of preschool children does not exist, while the school-entry screening is prescribed by law. The object of the study is to determine the prevalence of amblyopia in a 4-4.5 year old children of The Town of Zagreb, the efficacy of screening and effectiveness of treatment on reducing amblyopia prevalence. The primary hypothesis is defined: screening of visual acuity monocularly at distance and near in 4-4.5 year old children in Zagreb is effective in detecting amblyopia.

PATIENTS AND METHODS: Monocular vision of about 7000 children/ year aged 4-4.5 for whom both parents gave consent is to be tested with Lea chart at near (40cm) and distance (3m) in the kindergartens of The Town of Zagreb. The criterion for referral to complete ophthalmological examination is VA <0.8.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7000
• Est. completion date: September 12, 2014
• Est. primary completion date: September 12, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Months to 54 Months

Eligibility

Inclusion Criteria:

• children in the kindergartens of The Town of Zagreb aged 4-4.5 for whom both parents gave written informed consent

Exclusion Criteria:

• children younger than 4 years and children older than 4.5 years

Related Conditions & MeSH terms

• Amblyopia
• Anisometropia
• Ptosis
• Refractive Errors
• Strabismus

Intervention

Other:
• Amblyopia screening
Monocular vision testing at near (40cm) and distance (3m)

Locations

Country	Name	City	State
Croatia	University Eye Clinic, University Hospital "Sveti Duh"	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Mladen Busic

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of amblyopia	proportion of children with amblyopia in a total population of children screened	3 years