<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/NCT02241356</url>
  </required_header>
  <id_info>
    <org_study_id>R0002308</org_study_id>
    <secondary_id>2013-23</secondary_id>
    <nct_id>NCT02241356</nct_id>
  </id_info>
  <brief_title>The Effect of Bifocals in Children With Down Syndrome</brief_title>
  <official_title>The Effect of Bifocals in Children With Down Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Visual acuity at near improves in children with Down syndrome using bifocals&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and&#xD;
      does not improve with age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>• Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.</measure>
    <time_frame>baseline to 12 months later</time_frame>
    <description>visual acuity is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>• Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.</measure>
    <time_frame>after 12 months</time_frame>
    <description>visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.</measure>
    <time_frame>baseline to 12 months later</time_frame>
    <description>Visual acuity at distance is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change from baseline in accuracy of accommodation response measured in Dioptres.</measure>
    <time_frame>baseline to 12 months later</time_frame>
    <description>We will measure the accuracy of accommodation in Dioptres at baseline and after 16 months. We will calculate the difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in percentage of participants with strabismus</measure>
    <time_frame>baseline to 12 months later</time_frame>
    <description>We will calculate the percentage of participants with strabismus at baseline and at the end of the study, 16 months later. Then we can calculate the difference in percentage of participants with strabismus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Change in score of task readiness of the children</measure>
    <time_frame>baseline to 12 months later</time_frame>
    <description>We will measure task readiness in scores of attention, reaction time, inhibition and working memory at baseline and at the end of the study 16 months later. Then we calculate the difference in this score.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>• Possible prognostic determinants at baseline for improvement of visual acuity at near</measure>
    <time_frame>participants will be followed for the duration of 12 months, after the last included participant has been followed up for 18 months we will do this analysis</time_frame>
    <description>Applying a multivariate logistic regression model using a backward variable elimination procedure (selection criterion P &lt; 0.05, removal criterion P &lt; 0.10) to test a key set of independent prognostic variables (measured at baseline) for better visual acuity at near after 12 months</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Visual Acuity at Near</condition>
  <condition>Accuracy of Accommodation</condition>
  <condition>Prevention of Strabismus</condition>
  <condition>Task Readiness</condition>
  <arm_group>
    <arm_group_label>single vision glasses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>single vision glasses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bifocals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bifocal glasses</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>bifocals</intervention_name>
    <description>bifocal glasses with an addition of 2.5 Dioptres</description>
    <arm_group_label>bifocals</arm_group_label>
    <other_name>bifocal glasses</other_name>
    <other_name>reading glasses</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>single vision glasses</intervention_name>
    <description>single vision glasses</description>
    <arm_group_label>single vision glasses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Down syndrome (DS)&#xD;
&#xD;
          -  Accommodation lag &gt;0.5 Dioptres for children with DS &lt;12 years and &gt;0.75 Dioptres for&#xD;
             children older than age 12 or Visual acuity at near is worse than at distance and &gt;0.1&#xD;
&#xD;
          -  Age range 2-14 years&#xD;
&#xD;
          -  Speaks Dutch as the first language&#xD;
&#xD;
          -  Must be verbal or able to understand instructions&#xD;
&#xD;
          -  Must be able to perform a task sitting on a chair and working at a table&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visual acuity at near &lt; 0.1&#xD;
&#xD;
          -  Not able to do vision tests at age over 5&#xD;
&#xD;
          -  Has worn bifocals already&#xD;
&#xD;
          -  Other significant eye diseases, such as keratoconus, cataract or high myopia&#xD;
             (&gt;S-6.00).&#xD;
&#xD;
          -  Diagnoses of any neurological, sensory or behavioural disorders such as autism,&#xD;
             microcephaly or significant hearing loss.&#xD;
&#xD;
          -  Prematurity, born premature after a pregnancy term less than 36 weeks&#xD;
&#xD;
          -  Born after severe perinatal problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>H HL Goossens, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboudumc, Dept. Cognitive Neuroscience/126</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Isala Hospital</name>
      <address>
        <city>Zwolle</city>
        <state>Overijssel</state>
        <zip>8025 AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Nandakumar K, Leat SJ. Bifocals in children with Down syndrome (BiDS) - visual acuity, accommodation and early literacy skills. Acta Ophthalmol. 2010 Sep;88(6):e196-204. doi: 10.1111/j.1755-3768.2010.01944.x.</citation>
    <PMID>20626718</PMID>
  </reference>
  <reference>
    <citation>Al-Bagdady M, Stewart RE, Watts P, Murphy PJ, Woodhouse JM. Bifocals and Down's syndrome: correction or treatment? Ophthalmic Physiol Opt. 2009 Jul;29(4):416-21. doi: 10.1111/j.1475-1313.2009.00646.x. Epub 2009 May 11.</citation>
    <PMID>19470088</PMID>
  </reference>
  <reference>
    <citation>Cregg M, Woodhouse JM, Pakeman VH, Saunders KJ, Gunter HL, Parker M, Fraser WI, Sastry P. Accommodation and refractive error in children with Down syndrome: cross-sectional and longitudinal studies. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):55-63.</citation>
    <PMID>11133848</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Down syndrome</keyword>
  <keyword>visual functions</keyword>
  <keyword>bifocals</keyword>
  <keyword>children</keyword>
  <keyword>visual acuity at near</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Down Syndrome</mesh_term>
    <mesh_term>Strabismus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
  </intervention_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/NCT02241356
org study id: R0002308
secondary id: 2013-23
nct id: NCT02241356
lead sponsor: 
has dmc: Yes
Visual acuity at near improves in children with Down syndrome using bifocals
The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and
      does not improve with age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: • Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
time frame: baseline to 12 months later
description: visual acuity is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference.
measure: • Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
time frame: after 12 months
description: visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
measure: • Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months.
time frame: baseline to 12 months later
description: Visual acuity at distance is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference.
measure: • Change from baseline in accuracy of accommodation response measured in Dioptres.
time frame: baseline to 12 months later
description: We will measure the accuracy of accommodation in Dioptres at baseline and after 16 months. We will calculate the difference.
measure: • Change in percentage of participants with strabismus
time frame: baseline to 12 months later
description: We will calculate the percentage of participants with strabismus at baseline and at the end of the study, 16 months later. Then we can calculate the difference in percentage of participants with strabismus.
measure: • Change in score of task readiness of the children
time frame: baseline to 12 months later
description: We will measure task readiness in scores of attention, reaction time, inhibition and working memory at baseline and at the end of the study 16 months later. Then we calculate the difference in this score.
measure: • Possible prognostic determinants at baseline for improvement of visual acuity at near
time frame: participants will be followed for the duration of 12 months, after the last included participant has been followed up for 18 months we will do this analysis
description: Applying a multivariate logistic regression model using a backward variable elimination procedure (selection criterion P < 0.05, removal criterion P < 0.10) to test a key set of independent prognostic variables (measured at baseline) for better visual acuity at near after 12 months
arm group label: single vision glasses
arm group type: Active Comparator
description: single vision glasses
arm group label: bifocals
arm group type: Experimental
description: bifocal glasses
intervention type: Device
intervention name: bifocals
description: bifocal glasses with an addition of 2.5 Dioptres
arm group label: bifocals
other name: bifocal glasses
other name: reading glasses
intervention type: Device
intervention name: single vision glasses
description: single vision glasses
arm group label: single vision glasses
criteria: 
gender: All
minimum age: 2 Years
maximum age: 14 Years
healthy volunteers: No
last name: H HL Goossens, PhD
role: Principal Investigator
affiliation: Radboudumc, Dept. Cognitive Neuroscience/126
facility: 
country: Netherlands
citation: Nandakumar K, Leat SJ. Bifocals in children with Down syndrome (BiDS) - visual acuity, accommodation and early literacy skills. Acta Ophthalmol. 2010 Sep;88(6):e196-204. doi: 10.1111/j.1755-3768.2010.01944.x.
PMID: 20626718
citation: Al-Bagdady M, Stewart RE, Watts P, Murphy PJ, Woodhouse JM. Bifocals and Down's syndrome: correction or treatment? Ophthalmic Physiol Opt. 2009 Jul;29(4):416-21. doi: 10.1111/j.1475-1313.2009.00646.x. Epub 2009 May 11.
PMID: 19470088
citation: Cregg M, Woodhouse JM, Pakeman VH, Saunders KJ, Gunter HL, Parker M, Fraser WI, Sastry P. Accommodation and refractive error in children with Down syndrome: cross-sectional and longitudinal studies. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):55-63.
PMID: 11133848
responsible party type: Sponsor
mesh term: Down Syndrome
mesh term: Strabismus
mesh term: Methamphetamine