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AmblyopiaNCT01675193

Disinvestment Study of Population-Based Vision Screening in Children

A study testing Disinvestment protocol in people with Amblyopia, run by Erasmus Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the optimal screening intervals and cost-effectiveness of population-based vision screening in preverbal children in the Netherlands. Read more about this study

Who is it for?
Ages 6 to 14 monthsHealthy volunteers can take part
Conditions the study is for
Amblyopia
What is being tested?
Disinvestment protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,803 participants
Where
2 sitesNetherlands
Study dates
Feb 2012to 1 May 2017
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 6 to 14 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All children visiting the selected screening offices and becoming 6 months of age(in a 6 months period from the start of recruiting).

Who cannot join

  • previous eye surgery
  • previous eye disorder

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites
  • GGD Jeugdzorg Amsterdam

    Amsterdam

  • Icare Jeugdgezondheidszorg

    Meppel

Other trials in Netherlands

About this study

Official title: Disinvestment Study of Population-Based Vision Screening in Preverbal Children in the Netherlands

The purpose of this study is to determine the optimal screening intervals and cost-effectiveness of population-based vision screening in preverbal children in the Netherlands.

Read the detailed description

Amblyopia (prevalence 3 - 4%)is a preventable, unilateral loss of vision in young children, in most cases caused by strabismus (squint) or unilateral hypermetropia (need of plus glasses), or both. The sensitive period in which vision loss can develop and be recovered, by covering the better eye with a patch, is up to 6 years of age. Population-based programs for child vision screening exist in Sweden, the United Kingdom, Canada, eastern European countries and the Netherlands. Measurement of visual acuity at age four (preschool) is most common. In some countries, including Canada and the Netherlands, preverbal screening of visual function in infants and young children (age 0 - 2) has been added to the screening program. In the Netherlands, it is applied during the regular visits at ages 1-2, 3-4, 6-9, 14-24 months. At the age of 36 months, monocular visual acuity is tested with a picture chart. At the age of 45 and 60 months, monocular visual acuity is measured with the Landolt-C chart. In 1996, the investigators started a follow-up study of a birth cohort in Rotterdam (RAMSES) to determine the sensitivity, specificity and effectiveness of the screening program. A diagnosis of amblyopia was made in 100 (3.4%) of 2,964 children and was caused by refractive error (42), strabismus (19), both combined (30) or deprivation (7). It was found that most cases of amblyopia were detected by vision screening with measurement of visual acuity from age 3 years onwards. Preverbal screening enabled earlier detection of strabismus amblyopia, but not at all of refractive amblyopia.

The investigators therefore propose a disinvestment study of vision screening, with omission of screening at age 6-9 and 14-24 months. First, the optimal screening intervals are calculated with a newly developed micro-simulation model for effectiveness of repeated screening, on the basis of the data obtained in the RAMSES study. The model simulation predicted that screening at age 6-9 and 14-24 months can be omitted without an appreciable loss of number of detected amblyopia cases. This will be tested in a RCT among two large youth health care organisations, ICARE (12,500 new children annually) and GGD-Amsterdam. Two large birth-cohorts will be recruited. Children born between July and December 2011 will form our control group and will be examined at 6-9, 14-24, 36 and 45 months. Children born between January and June 2012 will be our intervention group. These children will be examined only at 36 and 45 months.

Endpoint is the number of cases of amblyopia detected, weighted for visual acuity, against age at detection. The question is whether a significant difference between groups can be found in the cumulative number of cases of amblyopia detected up to the age of 4 years. The new model for optimising screening intervals will be developed further in the course of the study into a generic tool for determining optimal screening intervals in any screening program with repeated exams for young children and should ultimately allow for comparison of effectiveness of population-based screening programs for different disorders in different countries, carried out by different personnel. Finally, in the RAMSES study 23% of the children screened positively had not been referred successfully to an ophthalmologist or orthoptist; 43% of their parents had low to moderate fluency in the Dutch language. This reflects lack of utilisation among immigrants of preventive screening and a faltering transit from prevention to care. Unsuccessful referral, in relation to parental fluency in Dutch, ethnicity and SES will, hence, be monitored in the study in an exploratory fashion.

Conditions
Amblyopia
Being tested
Disinvestment protocol
Keywords
Amblyopia, Vision-Screening
Medical subject headings
Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Disinvestment protocolBehavioural

    Omission of population-based child vision screening visits at 6-9 and 14-24 months: Children in the intervention group will not be eye screened at age 6-24 months

Study groups in NCT01675193
Study groupRoleWhat they receive
Current screening protocolNo interventionEye screening at age 1-2, 3-4, 6-9, 14-24, 36, 45 and 54-60 months
Disinvestment protocolOtherNo eye screening at 6-9 and 14-24 months
Receives: Behavioral: Disinvestment protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.

    The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.

    Measured: 2011-2016

Secondary outcomes (1)
  1. Cost-effectiveness analysis of vision screening in the two regions under both scenarios, with and without screening at age 6-9 and 14-24 months.

    Cost-effectiveness analysis of vision screening in the two regions under both scenarios, with and without screening at age 6-9 and 14-24 months.

    Measured: 2011-2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completion1 May 2017
  4. Study completion1 May 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10,803 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01675193
Sponsor's protocol ID
ErasmusMC MEC-2012-003
Status last verified
Aug 2017
First submitted
27 Aug 2012
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Sloot F, Sami A, Karaman H, Benjamins J, Loudon SE, Raat H, Sjoerdsma T, Simonsz HJ. Effect of omission of population-based eye screening at age 6-9 months in the Netherlands. Acta Ophthalmol. 2015 Jun;93(4):318-21. doi: 10.1111/aos.12556. Epub 2014 Oct 1.

    PubMed 25270899

Questions about this trial

What is this clinical trial studying?

A study testing Disinvestment protocol in people with Amblyopia, run by Erasmus Medical Center at 2 sites in Netherlands.

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 2 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

The number of cases of amblyopia detected, weighted for visual acuity, against age at detection. (time frame: 2011-2016). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01675193, which also lists 1 linked publication.

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 22 Aug 2017.

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