<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/NCT03814863</url>
  </required_header>
  <id_info>
    <org_study_id>ZOC</org_study_id>
    <nct_id>NCT03814863</nct_id>
  </id_info>
  <brief_title>China Red Eye Study</brief_title>
  <acronym>CRES</acronym>
  <official_title>China Red Eye Study</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study intends to use a hospital-based multi-center cross-sectional study to understand&#xD;
      the disease composition of &quot;red-eye&quot; patients in Chinese ophthalmology clinics. This study&#xD;
      will provide important clinical diagnosis and treatment data for common eye diseases in China&#xD;
      with &quot;red eye&quot; as the main performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Red eye is a common sign of eye diseases. Eye diseases such as ocular surface inflammation,&#xD;
      glaucoma, and uveitis can be expressed as red eyes. The disease with red eye as the main&#xD;
      complaint is the most common condition that clinicians need to identify. It is not uncommon&#xD;
      to be misdiagnosed and missed clinically. The collection and analysis of the disease&#xD;
      composition of the &quot;red eye&quot; in Chinese ophthalmology clinics will help to understand the&#xD;
      current status of &quot;red eye&quot; related diseases and provide a systematic and comprehensive&#xD;
      clinical basis for the differential diagnosis of red eye.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>medical diagnosis of each patient</measure>
    <time_frame>1 day (when the patient come the the doctor)</time_frame>
    <description>the investigators record patients' diagnosis on questionnaire when the patient come to the doctor</description>
  </primary_outcome>
  <enrollment type="Actual">4382</enrollment>
  <condition>Red Eye</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with &quot;red eye&quot;.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmation of signs under the slit lamp is red eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The investigator believes that there are any unsuitable reasons for participating in&#xD;
             the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center of Sun yat-sen Universtiy</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hainan Eye Hospital and Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Zhongshan Hospital of Dalian University</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Kunming Medical University and Hainan Eye Hospital</name>
      <address>
        <city>Kunming</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanxishan Hospital of Guangxi Zhuang Autonomous Region</name>
      <address>
        <city>Nanning</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>llege of Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the first affiliated hospital of Xinjiang medical university</name>
      <address>
        <city>Xinjiang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>April 11, 2020</last_update_submitted>
  <last_update_submitted_qc>April 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 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>Xiaofeng Lin</investigator_full_name>
    <investigator_title>associate dean of Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_title>
  </responsible_party>
  <keyword>red eye</keyword>
  <keyword>conjunctival congestion</keyword>
  <keyword>ophthalmology clinic</keyword>
  <!-- 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/NCT03814863
org study id: ZOC
nct id: NCT03814863
lead sponsor: 
is fda regulated drug: No
This study intends to use a hospital-based multi-center cross-sectional study to understand
      the disease composition of "red-eye" patients in Chinese ophthalmology clinics. This study
      will provide important clinical diagnosis and treatment data for common eye diseases in China
      with "red eye" as the main performance.
Red eye is a common sign of eye diseases. Eye diseases such as ocular surface inflammation,
      glaucoma, and uveitis can be expressed as red eyes. The disease with red eye as the main
      complaint is the most common condition that clinicians need to identify. It is not uncommon
      to be misdiagnosed and missed clinically. The collection and analysis of the disease
      composition of the "red eye" in Chinese ophthalmology clinics will help to understand the
      current status of "red eye" related diseases and provide a systematic and comprehensive
      clinical basis for the differential diagnosis of red eye.
observational model: Other
time perspective: Prospective
measure: medical diagnosis of each patient
time frame: 1 day (when the patient come the the doctor)
description: the investigators record patients' diagnosis on questionnaire when the patient come to the doctor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xiaofeng Lin
investigator title: associate dean of Zhongshan Ophthalmic Center, Sun Yat-sen University