AmblyopiaNCT01430247
Vision Screening for the Detection of Amblyopia
A study testing Amblyopia screening in people with Amblyopia and Refractive Errors, run by Mladen Busic at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 54 months
- Conditions the study is for
- Amblyopia, Refractive Errors, Anisometropia
- What is being tested?
- Amblyopia screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteCroatia
- Study dates
- 12 Sep 2011to 12 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 54 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children in the kindergartens of The Town of Zagreb aged 4-4.5 for whom both parents gave written informed consent
Who cannot join
- children younger than 4 years and children older than 4.5 years
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Eye Clinic, University Hospital "Sveti Duh"
Zagreb, 10 000
About this study
Official title: Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb
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.
Read more
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
- Being tested
- Amblyopia screening
- Keywords
- amblyopia, amblyogenic factors, screening, preschool children, visual acuity, prevalence
- Medical subject headings
- Amblyopia, Refractive Errors, Anisometropia, Strabismus, Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amblyopia screeningOther
Monocular vision testing at near (40cm) and distance (3m)
| Study group | Role | What they receive |
|---|---|---|
| Amblyopia screening | Other | Not described Receives: Other: Amblyopia screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of amblyopia
proportion of children with amblyopia in a total population of children screened
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study start12 Sep 2011
- Primary completion12 Sep 2014
- Study completion12 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mladen Busic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mladen Busic, General Hospital Sveti Duh
- Investigators
- Mladen Bušić, Principal investigator, University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430247
- Sponsor's protocol ID
- 30082011/2011
- Status last verified
- Jul 2019
- First submitted
- 31 Aug 2011
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision Screening of the Four Year Old Children for the Detection of Amblyopia in The Town of Zagreb
- ClinicalTrials.gov ID
- NCT01430247
- Acronym / sponsor ID
- 30082011/2011
- Conditions
- Amblyopia, Refractive Errors, Anisometropia, Strabismus, Ptosis
- Keywords
- amblyopia, amblyogenic factors, screening, preschool children, visual acuity, prevalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- Mladen BusicUniversity, hospital or other
- Study start
- 12 Sep 2011 (actual)
- Primary completion
- 12 Sep 2014 (actual)
- Study completion
- 12 Sep 2014 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amblyopia screening | Other | Other: Amblyopia screening |
Who may qualify
- Ages
- 48 to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children in the kindergartens of The Town of Zagreb aged 4-4.5 for whom both parents gave written informed consent
Key exclusion criteria (1 listed)
- children younger than 4 years and children older than 4.5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amblyopia screeningMonocular vision testing at near (40cm) and distance (3m) | Other | Amblyopia screening |
Primary outcome
prevalence of amblyopia
Time frame: 3 years
proportion of children with amblyopia in a total population of children screened
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mladen Bušić principal investigator
University Eye Clinic, University Hospital "Sveti Duh", Zagreb, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amblyopia screening in people with Amblyopia and Refractive Errors, run by Mladen Busic at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of amblyopia (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.