Vision Screening for the Detection of Amblyopia
|ClinicalTrials.gov Identifier: NCT01430247|
Recruitment Status : Unknown
Verified September 2011 by Mladen Busic, General Hospital Sveti Duh.
Recruitment status was: Enrolling by invitation
First Posted : September 8, 2011
Last Update Posted : September 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia Refractive Errors Anisometropia Strabismus Ptosis||Other: Amblyopia screening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2014|
Other: Amblyopia screening
Monocular vision testing at near (40cm) and distance (3m)
- prevalence of amblyopia [ Time Frame: 3 years ]proportion of children with amblyopia in a total population of children screened
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430247
|University Eye Clinic, University Hospital "Sveti Duh"|
|Zagreb, Croatia, 10 000|
|Principal Investigator:||Mladen Bušić||University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia|