Vision Screening for the Detection of Amblyopia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mladen Busic, General Hospital Sveti Duh
ClinicalTrials.gov Identifier:
NCT01430247
First received: August 31, 2011
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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 Intervention
Amblyopia
Refractive Errors
Anisometropia
Strabismus
Ptosis
Other: Amblyopia screening

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by General Hospital Sveti Duh:

Primary Outcome Measures:
  • prevalence of amblyopia [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    proportion of children with amblyopia in a total population of children screened


Estimated Enrollment: 7000
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amblyopia screening Other: Amblyopia screening
Monocular vision testing at near (40cm) and distance (3m)

  Eligibility

Ages Eligible for Study:   48 Months to 54 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430247

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

No publications provided

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
Study First Received: August 31, 2011
Last Updated: September 6, 2011
Health Authority: Croatia: Ethics Committee

Keywords provided by General Hospital Sveti Duh:
amblyopia
amblyogenic factors
screening
preschool children
visual acuity
prevalence

Additional relevant MeSH terms:
Amblyopia
Anisometropia
Refractive Errors
Strabismus
Brain Diseases
Central Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Ocular Motility Disorders
Sensation Disorders
Signs and Symptoms
Vision Disorders

ClinicalTrials.gov processed this record on October 22, 2014