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Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb
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.
Age
4 - 4 years
Sex
ALL
Healthy Volunteers
No
University Eye Clinic, University Hospital "Sveti Duh"
Zagreb, Croatia
Start Date
September 12, 2011
Primary Completion Date
September 12, 2014
Completion Date
September 12, 2014
Last Updated
August 2, 2019
7,000
ACTUAL participants
Amblyopia screening
OTHER
Lead Sponsor
Mladen Busic
NCT05458323
NCT07417046
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04378790