<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/NCT04449900</url>
  </required_header>
  <id_info>
    <org_study_id>2017MEKY034</org_study_id>
    <nct_id>NCT04449900</nct_id>
  </id_info>
  <brief_title>Quantitative Evaluation of Parafoveal Microvasculature Changes in Eyes With Exudative Circumscribed Choroidal Haemangioma: An Optical Coherence Tomography Angiography Study</brief_title>
  <official_title>Quantitative Evaluation of Parafoveal Microvasculature Changes in Eyes With Exudative Circumscribed Choroidal Haemangioma: An Optical Coherence Tomography Angiography 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>
    <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 study aims to quantitative evaluation of parafoveal microvasculature changes in eyes with&#xD;
      exudative circumscribed choroidal haemangioma using optical coherence tomography angiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Circumscribed choroidal haemangioma (CCH) is an uncommon, potentially congenital benign&#xD;
      vascular hamartomas which typically manifests as an elevated mass with reddish-orange&#xD;
      pigmentation located posteriorly to the equator, mostly in the macular and peripapillary&#xD;
      region. Despite its benign nature, cystoid macular edema (CME) or SRF due to the exudations&#xD;
      from the exudative CCH can cause visual impairment. Diagnosis is often suspected clinically,&#xD;
      and multimodal imaging is useful for the differential diagnosis of CCH from other malignant&#xD;
      tumors such as melanoma. Optical coherence tomography angiography (OCTA) is a rapid,&#xD;
      non-invasive, new imaging technology which could provide the capillary density (CD) of&#xD;
      superficial and deep capillary plexus as well as the CD of choriocapillaris of the&#xD;
      superficial, the latter two of which could not be seen on conventional FA or ICGA. However,&#xD;
      little knowledge is known about the parafoveal microvasculature changes in eyes with&#xD;
      exudative CCH on OCTA. Therefore, it is necessary to quantitative evaluation of parafoveal&#xD;
      microvasculature changes in eyes with exudative CCH compared with healthy eyes without any&#xD;
      disease. To the best of our knowledge, this is the first cross-sectional, case-control study&#xD;
      to use OCTA to quantitative evaluation of parafoveal microvasculature changes in Eyes with&#xD;
      exudative CCH compared with age- and gender-controlled healthy eyes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</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>Quantitative changes of parafoveal microvasculature in eyes with exudative circumscribed choroidal haemangioma</measure>
    <time_frame>3 years</time_frame>
    <description>Quantitative changes of parafoveal microvasculature in eyes with exudative circumscribed choroidal haemangioma compared wiyh healthy eyes.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">82</enrollment>
  <condition>Circumscribed Choroidal Haemangioma</condition>
  <condition>Optical Coherence Tomography Angiography</condition>
  <condition>Macular</condition>
  <arm_group>
    <arm_group_label>The exudative CCH group</arm_group_label>
    <description>Treatment naïve patients with exudative CCH which caused subfoveal retinal detachment and/or intraretinal fluid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The healthy eye control group</arm_group_label>
    <description>In the healthy eye control group, all eyes should have no ocular diseases and the best-corrected visual acuity (BCVA) should be 20/20 or better.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>This is observational study with the examination of OCTA</intervention_name>
    <description>This is observational study with the examination of OCTA</description>
    <arm_group_label>The exudative CCH group</arm_group_label>
    <arm_group_label>The healthy eye control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        There are two groups in this study: one is the exudative CCH group,and the other is the&#xD;
        healthy eye control group. They performed OCTA at baseline.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For patients with exudative CCH, the inclusion criteria were treatment naïve patients&#xD;
             with exudative CCH which caused subfoveal retinal detachment and/or intraretinal&#xD;
             fluid. For the healthy eye control group, only one eye (randomized by computer) of a&#xD;
             subject was included, and the included eyes should have no ocular diseases and the&#xD;
             best-corrected visual acuity (BCVA) should be 20/20 or better.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  without any other ocular diseases or any severe uncontrolled systemic diseases,&#xD;
             including uncontrolled hypertension, coronary heart disease, liver failure, and kidney&#xD;
             failure. all the subjects with high diopter &gt; -6D, long eye axis &gt; 26.0 mm, or the&#xD;
             quality of the acquired OCTA images below 7/10 should be excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhongshan 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 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 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>Jin Chen-jin</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangioma</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/NCT04449900
org study id: 2017MEKY034
nct id: NCT04449900
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study aims to quantitative evaluation of parafoveal microvasculature changes in eyes with
      exudative circumscribed choroidal haemangioma using optical coherence tomography angiography.
Circumscribed choroidal haemangioma (CCH) is an uncommon, potentially congenital benign
      vascular hamartomas which typically manifests as an elevated mass with reddish-orange
      pigmentation located posteriorly to the equator, mostly in the macular and peripapillary
      region. Despite its benign nature, cystoid macular edema (CME) or SRF due to the exudations
      from the exudative CCH can cause visual impairment. Diagnosis is often suspected clinically,
      and multimodal imaging is useful for the differential diagnosis of CCH from other malignant
      tumors such as melanoma. Optical coherence tomography angiography (OCTA) is a rapid,
      non-invasive, new imaging technology which could provide the capillary density (CD) of
      superficial and deep capillary plexus as well as the CD of choriocapillaris of the
      superficial, the latter two of which could not be seen on conventional FA or ICGA. However,
      little knowledge is known about the parafoveal microvasculature changes in eyes with
      exudative CCH on OCTA. Therefore, it is necessary to quantitative evaluation of parafoveal
      microvasculature changes in eyes with exudative CCH compared with healthy eyes without any
      disease. To the best of our knowledge, this is the first cross-sectional, case-control study
      to use OCTA to quantitative evaluation of parafoveal microvasculature changes in Eyes with
      exudative CCH compared with age- and gender-controlled healthy eyes.
observational model: Case-Control
time perspective: Prospective
measure: Quantitative changes of parafoveal microvasculature in eyes with exudative circumscribed choroidal haemangioma
time frame: 3 years
description: Quantitative changes of parafoveal microvasculature in eyes with exudative circumscribed choroidal haemangioma compared wiyh healthy eyes.
arm group label: The exudative CCH group
description: Treatment naïve patients with exudative CCH which caused subfoveal retinal detachment and/or intraretinal fluid
arm group label: The healthy eye control group
description: In the healthy eye control group, all eyes should have no ocular diseases and the best-corrected visual acuity (BCVA) should be 20/20 or better.
intervention type: Other
intervention name: This is observational study with the examination of OCTA
description: This is observational study with the examination of OCTA
arm group label: The exudative CCH group
arm group label: The healthy eye control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Jin Chen-jin
investigator title: Prof.
mesh term: Hemangioma
sharing ipd: No