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Vision Screening for the Detection of Amblyopia

NCT01430247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7000

Last updated 2019-08-02

No results posted yet for this study

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.

Conditions

  • Amblyopia
  • Refractive Errors
  • Anisometropia
  • Strabismus
  • Ptosis

Interventions

OTHER

Amblyopia screening

Monocular vision testing at near (40cm) and distance (3m)

Sponsors & Collaborators

  • Mladen Busic

    lead OTHER

Principal Investigators

  • Mladen Bušić · University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
48 Months
Max Age
54 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-12
Primary Completion
2014-09-12
Completion
2014-09-12

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01430247 on ClinicalTrials.gov