<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675193</url>
  </required_header>
  <id_info>
    <org_study_id>ErasmusMC MEC-2012-003</org_study_id>
    <nct_id>NCT01675193</nct_id>
  </id_info>
  <brief_title>Disinvestment Study of Population-Based Vision Screening in Children</brief_title>
  <official_title>Disinvestment Study of Population-Based Vision Screening in Preverbal Children in the Netherlands</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Public Health Service of Amsterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icare Youth Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the optimal screening intervals and&#xD;
      cost-effectiveness of population-based vision screening in preverbal children in the&#xD;
      Netherlands.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Amblyopia (prevalence 3 - 4%)is a preventable, unilateral loss of vision in young children,&#xD;
      in most cases caused by strabismus (squint) or unilateral hypermetropia (need of plus&#xD;
      glasses), or both. The sensitive period in which vision loss can develop and be recovered, by&#xD;
      covering the better eye with a patch, is up to 6 years of age. Population-based programs for&#xD;
      child vision screening exist in Sweden, the United Kingdom, Canada, eastern European&#xD;
      countries and the Netherlands. Measurement of visual acuity at age four (preschool) is most&#xD;
      common. In some countries, including Canada and the Netherlands, preverbal screening of&#xD;
      visual function in infants and young children (age 0 - 2) has been added to the screening&#xD;
      program. In the Netherlands, it is applied during the regular visits at ages 1-2, 3-4, 6-9,&#xD;
      14-24 months. At the age of 36 months, monocular visual acuity is tested with a picture&#xD;
      chart. At the age of 45 and 60 months, monocular visual acuity is measured with the Landolt-C&#xD;
      chart. In 1996, the investigators started a follow-up study of a birth cohort in Rotterdam&#xD;
      (RAMSES) to determine the sensitivity, specificity and effectiveness of the screening&#xD;
      program. A diagnosis of amblyopia was made in 100 (3.4%) of 2,964 children and was caused by&#xD;
      refractive error (42), strabismus (19), both combined (30) or deprivation (7). It was found&#xD;
      that most cases of amblyopia were detected by vision screening with measurement of visual&#xD;
      acuity from age 3 years onwards. Preverbal screening enabled earlier detection of strabismus&#xD;
      amblyopia, but not at all of refractive amblyopia.&#xD;
&#xD;
      The investigators therefore propose a disinvestment study of vision screening, with omission&#xD;
      of screening at age 6-9 and 14-24 months. First, the optimal screening intervals are&#xD;
      calculated with a newly developed micro-simulation model for effectiveness of repeated&#xD;
      screening, on the basis of the data obtained in the RAMSES study. The model simulation&#xD;
      predicted that screening at age 6-9 and 14-24 months can be omitted without an appreciable&#xD;
      loss of number of detected amblyopia cases. This will be tested in a RCT among two large&#xD;
      youth health care organisations, ICARE (12,500 new children annually) and GGD-Amsterdam. Two&#xD;
      large birth-cohorts will be recruited. Children born between July and December 2011 will form&#xD;
      our control group and will be examined at 6-9, 14-24, 36 and 45 months. Children born between&#xD;
      January and June 2012 will be our intervention group. These children will be examined only at&#xD;
      36 and 45 months.&#xD;
&#xD;
      Endpoint is the number of cases of amblyopia detected, weighted for visual acuity, against&#xD;
      age at detection. The question is whether a significant difference between groups can be&#xD;
      found in the cumulative number of cases of amblyopia detected up to the age of 4 years. The&#xD;
      new model for optimising screening intervals will be developed further in the course of the&#xD;
      study into a generic tool for determining optimal screening intervals in any screening&#xD;
      program with repeated exams for young children and should ultimately allow for comparison of&#xD;
      effectiveness of population-based screening programs for different disorders in different&#xD;
      countries, carried out by different personnel. Finally, in the RAMSES study 23% of the&#xD;
      children screened positively had not been referred successfully to an ophthalmologist or&#xD;
      orthoptist; 43% of their parents had low to moderate fluency in the Dutch language. This&#xD;
      reflects lack of utilisation among immigrants of preventive screening and a faltering transit&#xD;
      from prevention to care. Unsuccessful referral, in relation to parental fluency in Dutch,&#xD;
      ethnicity and SES will, hence, be monitored in the study in an exploratory fashion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">May 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.</measure>
    <time_frame>2011-2016</time_frame>
    <description>The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>2011-2016</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10803</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Current screening protocol</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Eye screening at age 1-2, 3-4, 6-9, 14-24, 36, 45 and 54-60 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Disinvestment protocol</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No eye screening at 6-9 and 14-24 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Disinvestment protocol</intervention_name>
    <description>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</description>
    <arm_group_label>Disinvestment protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All children visiting the selected screening offices and becoming 6 months of age(in a 6&#xD;
        months period from the start of recruiting).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous eye surgery&#xD;
&#xD;
          -  previous eye disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>14 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huibert J Simonsz, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>ErasmusMC, Department of Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GGD Jeugdzorg Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icare Jeugdgezondheidszorg</name>
      <address>
        <city>Meppel</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Huib Simonsz</investigator_full_name>
    <investigator_title>Prof. H.J. Simonsz, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Amblyopia</keyword>
  <keyword>Vision-Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amblyopia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675193
org study id: ErasmusMC MEC-2012-003
nct id: NCT01675193
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.
time frame: 2011-2016
description: The number of cases of amblyopia detected, weighted for visual acuity, against age at detection.
measure: 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.
time frame: 2011-2016
description: 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.
arm group label: Current screening protocol
arm group type: No Intervention
description: Eye screening at age 1-2, 3-4, 6-9, 14-24, 36, 45 and 54-60 months
arm group label: Disinvestment protocol
arm group type: Other
description: No eye screening at 6-9 and 14-24 months
intervention type: Behavioral
intervention name: Disinvestment protocol
description: 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
arm group label: Disinvestment protocol
criteria: 
gender: All
minimum age: 6 Months
maximum age: 14 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Huibert J Simonsz, MD, PhD
role: Study Chair
affiliation: ErasmusMC, Department of Ophthalmology
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Huib Simonsz
investigator title: Prof. H.J. Simonsz, MD, PhD
mesh term: Amblyopia