<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/NCT04441268</url>
  </required_header>
  <id_info>
    <org_study_id>CCPMOH2020-China-2</org_study_id>
    <nct_id>NCT04441268</nct_id>
  </id_info>
  <brief_title>Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Congenital Cataract</brief_title>
  <official_title>Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Unilateral and Bilateral Congenital Cataract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of prospective cohort study is to estimate the rate of change in postoperative&#xD;
      change after primary IOL implantation among children with congenital cataract(CC) and to&#xD;
      explore key factors associated with the rate of change.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Due to myopic shift, it's difficult to select power of IOL implanted in eye with congenital&#xD;
      cataract. The developmental profile of refraction among patient with congenital catarat is&#xD;
      has not yet been fully characterized. The investigator recruited a large cohort of Chinese CC&#xD;
      children.After primary IOL implatation, routine examinations including retinoscopy were&#xD;
      completed. Data were analysed to to estimate the rate of change in postoperative change after&#xD;
      primary IOL implantation among children with congenital cataract and to explore key factors&#xD;
      associated with the rate of change.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>The refraction status (presented as spherical equivalent, SE)</measure>
    <time_frame>up to three years after surgery</time_frame>
    <description>Refractions were conducted with objective retinoscopy after cycloplegia, and performed by experienced optometrists.</description>
  </primary_outcome>
  <enrollment type="Actual">335</enrollment>
  <condition>Cataract</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>primary IOL implantation</intervention_name>
    <description>implant IOL in capsular bag after cataract extraction</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        CC patients underwent surgery of cataratc extraction and primary intraocular lens (IOL)&#xD;
        implantation at the Zhongshan Ophthalmic Center between 2010 and 2016 were recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with uncomplicated surgeries&#xD;
&#xD;
          -  Children with unilateral/bilateral cataract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corneal diseases&#xD;
&#xD;
          -  Lens luxation&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Retinal diseases&#xD;
&#xD;
          -  Nystagmus and nanophthalmos&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Months</minimum_age>
    <maximum_age>12 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Chen Weirong, MD</last_name>
    <role>Study Chair</role>
    <affiliation>SunYat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhognshan Ophthalmic Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Haotian Lin</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </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/NCT04441268
org study id: CCPMOH2020-China-2
nct id: NCT04441268
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of prospective cohort study is to estimate the rate of change in postoperative
      change after primary IOL implantation among children with congenital cataract(CC) and to
      explore key factors associated with the rate of change.
Due to myopic shift, it's difficult to select power of IOL implanted in eye with congenital
      cataract. The developmental profile of refraction among patient with congenital catarat is
      has not yet been fully characterized. The investigator recruited a large cohort of Chinese CC
      children.After primary IOL implatation, routine examinations including retinoscopy were
      completed. Data were analysed to to estimate the rate of change in postoperative change after
      primary IOL implantation among children with congenital cataract and to explore key factors
      associated with the rate of change.
observational model: Cohort
time perspective: Prospective
measure: The refraction status (presented as spherical equivalent, SE)
time frame: up to three years after surgery
description: Refractions were conducted with objective retinoscopy after cycloplegia, and performed by experienced optometrists.
intervention type: Procedure
intervention name: primary IOL implantation
description: implant IOL in capsular bag after cataract extraction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Months
maximum age: 12 Years
last name: Chen Weirong, MD
role: Study Chair
affiliation: SunYat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Haotian Lin
investigator title: Clinical Professor
mesh term: Cataract
mesh term: Refractive Errors
sharing ipd: Yes