<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/NCT03270761</url>
  </required_header>
  <id_info>
    <org_study_id>2017KYPJ071</org_study_id>
    <nct_id>NCT03270761</nct_id>
  </id_info>
  <brief_title>Zhongshan Iridocorneal Endothelial Syndrome Study (ICEs)</brief_title>
  <official_title>A Multi-center Study on Iridocorneal Endothelial (ICE) Syndrome in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ICE study group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      This is a multi-center study to report the demographic profile, clinical features, and&#xD;
      management in patients with Iridocorneal endothelial (ICE) syndrome in China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 12, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Management in patients with Iridocorneal endothelial (ICE) syndrome</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Record the number of medication treating corneal edema or glaucoma, and surgery (anti-glaucoma surgery, keratoplasty)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic profile of patients</measure>
    <time_frame>1 day</time_frame>
    <description>Range of age, gender</description>
  </secondary_outcome>
  <enrollment type="Actual">98</enrollment>
  <condition>Glaucoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      12ml Blood will be collected. Aqueous humor，iris,or excised corneal will be gathered if&#xD;
      trabeculectomy,drainage shunt valve implantation, or penetrating keratoplasty needed.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        ICE syndrome patients identified and enrolled from 50 study centers in China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of ICE syndrome;&#xD;
&#xD;
          -  Those willing to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who don't sign the informed consent or abide by the study procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiulan Zhang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center</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 2021</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>June 6, 2021</last_update_submitted>
  <last_update_submitted_qc>June 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Xiulan Zhang</investigator_full_name>
    <investigator_title>MD,PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03270761
org study id: 2017KYPJ071
nct id: NCT03270761
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multi-center study to report the demographic profile, clinical features, and
      management in patients with Iridocorneal endothelial (ICE) syndrome in China.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Management in patients with Iridocorneal endothelial (ICE) syndrome
time frame: through study completion, an average of 1 year
description: Record the number of medication treating corneal edema or glaucoma, and surgery (anti-glaucoma surgery, keratoplasty)
measure: Demographic profile of patients
time frame: 1 day
description: Range of age, gender
12ml Blood will be collected. Aqueous humor，iris,or excised corneal will be gathered if
      trabeculectomy,drainage shunt valve implantation, or penetrating keratoplasty needed.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xiulan Zhang, MD,PhD
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xiulan Zhang
investigator title: MD,PhD
mesh term: Glaucoma
sharing ipd: No