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Vision Screening for the Detection of Amblyopia

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ClinicalTrials.gov Identifier: NCT01430247
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Mladen Busic, General Hospital Sveti Duh

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 Type : Interventional  (Clinical Trial)
Actual 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
Actual Study Start Date : September 12, 2011
Actual Primary Completion Date : September 12, 2014
Actual Study Completion Date : September 12, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arms and Interventions
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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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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 ClinicalTrials.gov identifier (NCT number): NCT01430247


Locations
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Croatia
University Eye Clinic, University Hospital "Sveti Duh"
Zagreb, Croatia, 10 000
Sponsors and Collaborators
Mladen Busic
Investigators
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Principal Investigator: Mladen Bušić University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia
More Information
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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    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Keywords provided by Mladen Busic, General Hospital Sveti Duh:
amblyopia
amblyogenic factors
screening
 preschool children
visual acuity
prevalence
Additional relevant MeSH terms:
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Amblyopia
Strabismus
Refractive Errors
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