<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/NCT02238002</url>
  </required_header>
  <id_info>
    <org_study_id>WZMC2013QQFYJ</org_study_id>
    <nct_id>NCT02238002</nct_id>
  </id_info>
  <brief_title>Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification</brief_title>
  <acronym>AOACCCAP</acronym>
  <official_title>To Investigate Changes in Anterior Chamber Angle Configuration After Phacoemulsification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zheng Qian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate changes in anterior chamber angle configuration after phacoemulsification and&#xD;
      intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate changes in anterior chamber angle configuration after phacoemulsification and&#xD;
      intraocular lens (IOL) implantation in eyes with a shallow anterior chamber and narrow angle,&#xD;
      compared with the eyes with normal anterior chamber and open angle using Swept-Source Optical&#xD;
      Coherence Tomography (SS-OCT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>anterior chamber angle parameters increased</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Cataract</condition>
  <condition>Shallow Anterior Chamber</condition>
  <condition>Narrow Angle</condition>
  <arm_group>
    <arm_group_label>normal angle</arm_group_label>
    <description>normal anterior chamber and open angle eyes underwent cataract surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>narrow angle</arm_group_label>
    <description>shallow anterior chamber and narrow angle eyes underwent cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cataract surgery</intervention_name>
    <description>The patients of both groups underwent cataract surgery</description>
    <arm_group_label>narrow angle</arm_group_label>
    <arm_group_label>normal angle</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients who underwent phacoemulsification surgery in Eye Hospital of Wenzhou Medical&#xD;
        University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ACD was less than 2.68mm. the anterior chamber angle width on gonioscopy≤Shaffer 2 .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        primary or secondary glaucoma, peripheral anterior synechiae, history of ocular surgeries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yun e Zhao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qian Zheng, MD</last_name>
    <phone>18367839685</phone>
    <email>zq15.04@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eye Hospital of Wenzhou Medical University</name>
      <address>
        <city>WenZhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qian Zheng</last_name>
      <phone>18367839685</phone>
      <email>zq15.04@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Zheng Qian</investigator_full_name>
    <investigator_title>Wenzhou Medical University</investigator_title>
  </responsible_party>
  <keyword>shallow anterior chamber</keyword>
  <keyword>narrow angle</keyword>
  <keyword>SS-OCT</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/NCT02238002
org study id: WZMC2013QQFYJ
nct id: NCT02238002
lead sponsor: 
has dmc: No
To investigate changes in anterior chamber angle configuration after phacoemulsification and
      intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).
To investigate changes in anterior chamber angle configuration after phacoemulsification and
      intraocular lens (IOL) implantation in eyes with a shallow anterior chamber and narrow angle,
      compared with the eyes with normal anterior chamber and open angle using Swept-Source Optical
      Coherence Tomography (SS-OCT).
observational model: Cohort
time perspective: Prospective
measure: anterior chamber angle parameters increased
time frame: 1 year
arm group label: normal angle
description: normal anterior chamber and open angle eyes underwent cataract surgery
arm group label: narrow angle
description: shallow anterior chamber and narrow angle eyes underwent cataract surgery
intervention type: Procedure
intervention name: cataract surgery
description: The patients of both groups underwent cataract surgery
arm group label: narrow angle
arm group label: normal angle
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yun e Zhao, MD
role: Principal Investigator
affiliation: Wenzhou Medical University
last name: Qian Zheng, MD
phone: 18367839685
email: zq15.04@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Zheng Qian
investigator title: Wenzhou Medical University
mesh term: Cataract