Vision Screening for the Detection of Amblyopia

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Amblyopia; Refractive Errors; Anisometropia; Strabismus; Ptosis	Other: Amblyopia screening	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	7000 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Amblyopia screening	Other: Amblyopia screening; Monocular vision testing at near (40cm) and distance (3m)

Outcome Measures

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Primary Outcome Measures :

1. prevalence of amblyopia [ Time Frame: 3 years ]
   proportion of children with amblyopia in a total population of children screened

Eligibility Criteria

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Ages Eligible for Study:	48 Months to 54 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Croatia
University Eye Clinic, University Hospital "Sveti Duh"
Zagreb, Croatia, 10 000

Sponsors and Collaborators

Mladen Busic

Investigators

Principal Investigator:	Mladen Bušić	University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mladen Busic, Asst. prof., M.D., PhD, General Hospital Sveti Duh
ClinicalTrials.gov Identifier:	NCT01430247 History of Changes
Other Study ID Numbers:	30082011/2011
First Posted:	September 8, 2011
Last Update Posted:	September 8, 2011
Last Verified:	September 2011

Keywords provided by Mladen Busic, General Hospital Sveti Duh:

amblyopia; amblyogenic factors; screening	preschool children; visual acuity; prevalence

Additional relevant MeSH terms:

Amblyopia; Refractive Errors; Strabismus; Anisometropia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases