<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/NCT03778528</url>
  </required_header>
  <id_info>
    <org_study_id>17-0372</org_study_id>
    <nct_id>NCT03778528</nct_id>
  </id_info>
  <brief_title>Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome</brief_title>
  <official_title>Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study involves the collection ocular lens tissue from individuals with Down syndrome and&#xD;
      age-matched controls at the time of cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with Down syndrome have an increased rate of cataract. The reason for this&#xD;
      increase is unclear. Normally, once cataracts become a significant impairment, an&#xD;
      ophthalmologist will determine when cataract surgery should be performed. When this surgery&#xD;
      is performed, cataractous tissues are cut out and discarded with medical waste. In this&#xD;
      study, these tissue will be collected and protein analysis performed to determine what&#xD;
      changes in different proteins are found in Down syndrome lenses as compared to normal&#xD;
      cataractous lenses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    researcher left the institution study will not continue&#xD;
  </why_stopped>
  <start_date type="Actual">May 30, 2018</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in protein composition</measure>
    <time_frame>one week after collection of tissue</time_frame>
    <description>western blot analysis of proteins from cataractous tissue</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Cataract</condition>
  <condition>Down Syndrome</condition>
  <arm_group>
    <arm_group_label>Down syndrome</arm_group_label>
    <description>Individuals with Down syndrome undergoing cataract surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Age-matched controls undergoing cataract surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cataract surgery</intervention_name>
    <description>tissue collection.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Down syndrome</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      cataractous tissue removed at time of cataract surgery&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with Down syndrome having cataract surgery or age-matched control.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing cataract surgery for lens extraction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known genetic cause other than Down syndrome causing cataract.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Down Syndrome</mesh_term>
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Age, trisomy status, protein concentration levels</ipd_description>
  </patient_data>
  <!-- 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/NCT03778528
org study id: 17-0372
nct id: NCT03778528
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study involves the collection ocular lens tissue from individuals with Down syndrome and
      age-matched controls at the time of cataract surgery.
Individuals with Down syndrome have an increased rate of cataract. The reason for this
      increase is unclear. Normally, once cataracts become a significant impairment, an
      ophthalmologist will determine when cataract surgery should be performed. When this surgery
      is performed, cataractous tissues are cut out and discarded with medical waste. In this
      study, these tissue will be collected and protein analysis performed to determine what
      changes in different proteins are found in Down syndrome lenses as compared to normal
      cataractous lenses.
observational model: Cohort
time perspective: Prospective
measure: Change in protein composition
time frame: one week after collection of tissue
description: western blot analysis of proteins from cataractous tissue
arm group label: Down syndrome
description: Individuals with Down syndrome undergoing cataract surgery.
arm group label: Control
description: Age-matched controls undergoing cataract surgery.
intervention type: Procedure
intervention name: cataract surgery
description: tissue collection.
arm group label: Control
arm group label: Down syndrome
cataractous tissue removed at time of cataract surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Down Syndrome
mesh term: Cataract
mesh term: Syndrome
sharing ipd: No
ipd description: Age, trisomy status, protein concentration levels