<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/NCT01666821</url>
  </required_header>
  <id_info>
    <org_study_id>04-E-1</org_study_id>
    <nct_id>NCT01666821</nct_id>
  </id_info>
  <brief_title>A Population-based Study of Macular Choroidal Neovascularization in a Chinese Population</brief_title>
  <official_title>A Population-based Study of Macular Choroidal Neovascularization Using Optical Coherence Tomography in a Chinese Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate pathomorphological and functional variations of choroidal neovascularization&#xD;
      (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical&#xD;
      coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative&#xD;
      AMD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This population-based study enrolled 59 patients (&gt;45 years old; 70 eyes) with early and&#xD;
      intermediate-stage AMD from Youyi Street, Baoshan District, Shanghai, China. Comprehensive&#xD;
      standardized ophthalmic examinations included visual acuity, anterior segment analysis by&#xD;
      slit lamp, dilated fundus evaluation by direct ophthalmoscopy, 90D handheld lens, fundus&#xD;
      photography, fluorescein angiography (FFA), and fast optic disk scans using OCT. The macular&#xD;
      CNV characteristic profiles in early and intermediate-stage AMD were determined by OCT. Data&#xD;
      were obtained at first visit and 6 to 24 months follow-up, and FFA and OCT outcomes of early&#xD;
      and intermediate-stage AMD patients were analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2004</start_date>
  <completion_date type="Actual">January 2009</completion_date>
  <primary_completion_date type="Actual">September 2008</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change of the early and intermediate-stage AMD</measure>
    <time_frame>May 2004-September 2008</time_frame>
    <description>Drusen with unclear boundaries and obvious pigment proliferation, with hypofluorescence around drusens seen on FFA and a slight small arch field located in the retinal pigment epithelium (RPE)/choriocapillary layer (CCL) on OCT indicated exudative AMD.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Geographic Atrophy</condition>
  <condition>Wet Macular Degeneration</condition>
  <condition>Retinal Drusen</condition>
  <arm_group>
    <arm_group_label>early and intermediate-stage AMD</arm_group_label>
    <description>Follow-up observation was implemented in whose fundus examination show lesions in the early and intermediate-stage AMD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up observation</intervention_name>
    <description>a epidemiologic survey of ocular diseases in an adult population (&gt;45 years old) in Youyi Street, Baoshan District, Shanghai, China, conducted to determine the prevalence of AMD in the region. To this end, we utilized routine ocular examinations</description>
    <arm_group_label>early and intermediate-stage AMD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        recruited 1813 adults citizens aged above 45 years by probability sampling from the Youyi&#xD;
        Street, Baoshan District, Shanghai, China for an epidemiologic survey. All participants&#xD;
        gave written informed consent, and this study was approved by the local Ethics Committee in&#xD;
        accordance with the Helsinki Declaration.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults citizens aged above 45 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lost samples&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zhao jie, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director of ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Youyi Street</name>
      <address>
        <city>Shanghai</city>
        <state>Baoshan District</state>
        <zip>201900</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Jun Hu</investigator_full_name>
    <investigator_title>Department of ophthalmology, Shuguang hospital(Baoshan branch),Shanghai University of TCM</investigator_title>
  </responsible_party>
  <keyword>macular degeneration; choroidal neovascularization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Geographic Atrophy</mesh_term>
    <mesh_term>Wet Macular Degeneration</mesh_term>
    <mesh_term>Retinal Drusen</mesh_term>
    <mesh_term>Neovascularization, Pathologic</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/NCT01666821
org study id: 04-E-1
nct id: NCT01666821
lead sponsor: 
has dmc: Yes
To investigate pathomorphological and functional variations of choroidal neovascularization
      (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical
      coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative
      AMD.
This population-based study enrolled 59 patients (>45 years old; 70 eyes) with early and
      intermediate-stage AMD from Youyi Street, Baoshan District, Shanghai, China. Comprehensive
      standardized ophthalmic examinations included visual acuity, anterior segment analysis by
      slit lamp, dilated fundus evaluation by direct ophthalmoscopy, 90D handheld lens, fundus
      photography, fluorescein angiography (FFA), and fast optic disk scans using OCT. The macular
      CNV characteristic profiles in early and intermediate-stage AMD were determined by OCT. Data
      were obtained at first visit and 6 to 24 months follow-up, and FFA and OCT outcomes of early
      and intermediate-stage AMD patients were analyzed.
observational model: Ecologic or Community
time perspective: Prospective
measure: change of the early and intermediate-stage AMD
time frame: May 2004-September 2008
description: Drusen with unclear boundaries and obvious pigment proliferation, with hypofluorescence around drusens seen on FFA and a slight small arch field located in the retinal pigment epithelium (RPE)/choriocapillary layer (CCL) on OCT indicated exudative AMD.
arm group label: early and intermediate-stage AMD
description: Follow-up observation was implemented in whose fundus examination show lesions in the early and intermediate-stage AMD
intervention type: Other
intervention name: Follow-up observation
description: a epidemiologic survey of ocular diseases in an adult population (>45 years old) in Youyi Street, Baoshan District, Shanghai, China, conducted to determine the prevalence of AMD in the region. To this end, we utilized routine ocular examinations
arm group label: early and intermediate-stage AMD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: zhao jie, master
role: Principal Investigator
affiliation: Director of ophthalmology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai University of Traditional Chinese Medicine
investigator full name: Jun Hu
investigator title: Department of ophthalmology, Shuguang hospital(Baoshan branch),Shanghai University of TCM
mesh term: Macular Degeneration
mesh term: Choroidal Neovascularization
mesh term: Geographic Atrophy
mesh term: Wet Macular Degeneration
mesh term: Retinal Drusen
mesh term: Neovascularization, Pathologic