Vision Screening for the Detection of Amblyopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Mladen Busic, General Hospital Sveti Duh

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 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

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

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01430247

University Eye Clinic, University Hospital "Sveti Duh"
Zagreb, Croatia, 10 000
Sponsors and Collaborators
Mladen Busic
Principal Investigator: Mladen Bušić University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia

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

Keywords provided by Mladen Busic, General Hospital Sveti Duh:
amblyogenic factors
preschool children
visual acuity

Additional relevant MeSH terms:
Refractive Errors
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