NCT01430247

Vision Screening for the Detection of Amblyopia

Completed NA Last updated 2 August 2019

What this trial tests

NA trial testing Amblyopia screening in Amblyopia in 7,000 participants. Completed in 12 September 2014.

Timeline

12 September 2011

Primary endpoint
12 September 2014

12 September 2014

Quick facts

Lead sponsor	Mladen Busic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	7,000
Start date	12 September 2011
Primary completion	12 September 2014
Estimated completion	12 September 2014
Sites	1 location across Croatia

Drugs / interventions tested

• Amblyopia screening

Conditions studied

• Amblyopia — all drugs for Amblyopia →
• Refractive Errors — all drugs for Refractive Errors →
• Anisometropia — all drugs for Anisometropia →
• Strabismus — all drugs for Strabismus →

Sponsor

Mladen Busic

Who can join

Adults 48 Months to 54 Months, any sex, with Amblyopia or Refractive Errors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Childhood amblyopia: current management and new trends.
   Tailor V, Bossi M, Greenwood JA, Dahlmann-Noor A. · · 2016 · cited 67× · PMID 27543498 · DOI 10.1093/bmb/ldw030