<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/NCT04427748</url>
  </required_header>
  <id_info>
    <org_study_id>Electrophysiology-WJJ</org_study_id>
    <nct_id>NCT04427748</nct_id>
  </id_info>
  <brief_title>Electrophysiology in Congenital Cataract After Lensectomy and Anterior</brief_title>
  <official_title>The Change of Electrophysiology in Congenital Cataract After Lensectomy and Anterior Vitrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal&#xD;
      eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after&#xD;
      lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and&#xD;
      b-wave and PhNR related parameters was evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and&#xD;
      primary IOL implantation in children with congenital cataract were both performed by the same&#xD;
      surgeon(Z.Y.E).&#xD;
&#xD;
      electroretinography and photopic negative response are performed to each patient.The research&#xD;
      was to evaluate the relationship between the best corrected visionn and the related&#xD;
      parameters of a- and b-wave and PhNR .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 3, 2019</completion_date>
  <primary_completion_date type="Actual">September 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ERG</measure>
    <time_frame>at least 1year after the surgery of congenital cataract</time_frame>
    <description>investigate retinal function changes of congenital cataract children. ERG related parameters including a- and b-wave and PhNR amplitude and latency.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">116</enrollment>
  <condition>Congenital Cataract</condition>
  <arm_group>
    <arm_group_label>congenital cataract group</arm_group_label>
    <description>children with congenital cataract who underwent lensectomy and anterior vitrectomy and IOL implantation are perfomed ERG</description>
  </arm_group>
  <arm_group>
    <arm_group_label>age-matched normal children group</arm_group_label>
    <description>age-matched normal children are perfomed ERG</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        congenital cataract age from 1.5 years to 15 years who underwent cataract surgery at least&#xD;
        1 year&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  phakic children diagnosed with congenital cataract who underwent secondary IOL&#xD;
             implantation and children with congenital cataract who underwent lensectomy and&#xD;
             anterior vitrectomy and primary IOL implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with mild cataracts do not require surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eye Hosptial of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>yin ying zhao</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <keyword>ERG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT04427748
org study id: Electrophysiology-WJJ
nct id: NCT04427748
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal
      eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after
      lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and
      b-wave and PhNR related parameters was evaluated.
Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and
      primary IOL implantation in children with congenital cataract were both performed by the same
      surgeon(Z.Y.E).

      electroretinography and photopic negative response are performed to each patient.The research
      was to evaluate the relationship between the best corrected visionn and the related
      parameters of a- and b-wave and PhNR .
observational model: Case-Control
time perspective: Prospective
measure: ERG
time frame: at least 1year after the surgery of congenital cataract
description: investigate retinal function changes of congenital cataract children. ERG related parameters including a- and b-wave and PhNR amplitude and latency.
arm group label: congenital cataract group
description: children with congenital cataract who underwent lensectomy and anterior vitrectomy and IOL implantation are perfomed ERG
arm group label: age-matched normal children group
description: age-matched normal children are perfomed ERG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Months
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: yin ying zhao
investigator title: Clinical professor
mesh term: Cataract