Vision Screening for the Detection of Amblyopia

NCT01430247 | Completed

• 1 other identifier: 30082011/2011
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

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

Keywords

amblyopia; amblyogenic factors; screening; preschool children; visual acuity; prevalence

Outcome Measures

Primary Outcomes (1)

• prevalence of amblyopia

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

  3 years

Study Arms (1)

Amblyopia screening

OTHER

Other: Amblyopia screening

Interventions

Amblyopia screening OTHER

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

Amblyopia screening

Eligibility Criteria

• Age: 48 Months - 54 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children in the kindergartens of The Town of Zagreb aged 4-4.5 for whom both parents gave written informed consent

You may not qualify if:

• children younger than 4 years and children older than 4.5 years

Sponsors & Collaborators

• Mladen Busic: lead

Study Sites (1)

University Eye Clinic, University Hospital "Sveti Duh"

Zagreb, 10 000, Croatia

Location

MeSH Terms

Conditions

Amblyopia; Refractive Errors; Anisometropia; Strabismus; Blepharoptosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases; Eyelid Diseases

Study Officials

• Mladen Bušić

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. prof., M.D., PhD

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 8, 2011
• Study Start: September 12, 2011
• Primary Completion: September 12, 2014
• Study Completion: September 12, 2014
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

CR (1)