Vision Screening for the Detection of Amblyopia

NCT ID: NCT01430247

Last Updated: 2019-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-12
• Study Completion Date: 2014-09-12

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.

Conditions

Amblyopia; Refractive Errors; Anisometropia; Strabismus; Ptosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Amblyopia screening

Group Type: OTHER

Amblyopia screening

Intervention Type: OTHER

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

Interventions

Amblyopia screening

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 48 Months
• Maximum Eligible Age: 54 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mladen Busic

OTHER

Sponsor Role: lead

Responsible Party

Mladen Busic

Asst. prof., M.D., PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mladen Bušić

Role: PRINCIPAL_INVESTIGATOR

University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia

Locations

University Eye Clinic, University Hospital "Sveti Duh"

Zagreb, , Croatia

Countries

Croatia

Other Identifiers

30082011/2011

Identifier Type: -

Identifier Source: org_study_id