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Vision Screening for the Detection of Amblyopia

Primary Purpose

Amblyopia, Refractive Errors, Anisometropia

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Amblyopia screening
Sponsored by
Mladen Busic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Amblyopia focused on measuring amblyopia, amblyogenic factors, screening, preschool children, visual acuity, prevalence

Eligibility Criteria

48 Months - 54 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Eye Clinic, University Hospital "Sveti Duh"

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Amblyopia screening

Arm Description

Outcomes

Primary Outcome Measures

prevalence of amblyopia
proportion of children with amblyopia in a total population of children screened

Secondary Outcome Measures

Full Information

First Posted
August 31, 2011
Last Updated
July 31, 2019
Sponsor
Mladen Busic
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1. Study Identification

Unique Protocol Identification Number
NCT01430247
Brief Title
Vision Screening for the Detection of Amblyopia
Official Title
Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 12, 2011 (Actual)
Primary Completion Date
September 12, 2014 (Actual)
Study Completion Date
September 12, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mladen Busic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Refractive Errors, Anisometropia, Strabismus, Ptosis
Keywords
amblyopia, amblyogenic factors, screening, preschool children, visual acuity, prevalence

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amblyopia screening
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Amblyopia screening
Intervention Description
Monocular vision testing at near (40cm) and distance (3m)
Primary Outcome Measure Information:
Title
prevalence of amblyopia
Description
proportion of children with amblyopia in a total population of children screened
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mladen Bušić
Organizational Affiliation
University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Eye Clinic, University Hospital "Sveti Duh"
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia

12. IPD Sharing Statement

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Vision Screening for the Detection of Amblyopia

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