Clinical trial NCT01430247: Vision Screening for the Detection of Amblyopia
Official title: Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Refractive Errors
Anisometropia
Strabismus
Ptosis
Keywords: amblyopia
amblyogenic factors
screening
preschool children
visual acuity
prevalence
Lead sponsor: General Hospital Sveti Duh
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 7000
Sex: ALL
Minimum age (years): 48
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: prevalence of amblyopia
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Eye Clinic, University Hospital "Sveti Duh"
Study officials:
affiliation: University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia
name: Mladen Bušić
role: PRINCIPAL_INVESTIGATOR
References: