<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/NCT03779542</url>
  </required_header>
  <id_info>
    <org_study_id>HM-AOD-HZ</org_study_id>
    <nct_id>NCT03779542</nct_id>
  </id_info>
  <brief_title>Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification With Swept-Source Optical Coherence Tomography</brief_title>
  <official_title>Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification With Swept-Source Optical Coherence Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yune Zhao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the changes of anterior chamber angle in patients with shallow anterior chamber and&#xD;
      normal anterior chamber after phacoemulsification and intraocular lens implantation (IOL)&#xD;
      using anterior segment swept-source optical coherence tomography (AS-SS-OCT).To observe the&#xD;
      60 eyes of 60 patients in our study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective case-control study; 60 eyes of 60 patients who underwent cataract&#xD;
      surgery. Based on anterior chamber depth (ACD) and gonioscopy findings, the eyes are&#xD;
      classified into two groups, shallow anterior chamber group (30 eyes) and narrow anterior&#xD;
      chamber group (30 eyes). AS-SS-OCT was used to measure ACD and angle parameters (angle&#xD;
      opening distance(AOD), angle recess area(ARA), trabecular iris space area（TISA）, and&#xD;
      trabecular iris angle (TIA). Serial changes in each group were measured before and 3 months&#xD;
      after phacoemulsification and IOL, and the differences between the two groups were compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>anterior chamber depth</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Anterior Chamber Parameters</condition>
  <condition>Phacoemulsification</condition>
  <condition>Anterior Segment Swept-source Optical Coherence Tomography</condition>
  <arm_group>
    <arm_group_label>open-angle group</arm_group_label>
    <description>ACD &gt; 2.68 measured by the swept source AS-OCT and angle &gt; Shaffer 2 in four quadrants under gonioscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>narrow-angle group</arm_group_label>
    <description>ACD≤2.68 measured by the swept source AS-OCT and angle≤Shaffer 2 in four quadrants under gonioscope</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cataract surgery</intervention_name>
    <description>phacoemulsification and intraocular lens implantation</description>
    <arm_group_label>narrow-angle group</arm_group_label>
    <arm_group_label>open-angle group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients who underwent cataract surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: patients who underwent cataract surgery -&#xD;
&#xD;
        Exclusion Criteria:patients with mild cataracts do not require surgery&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Man Hu, MD</last_name>
    <phone>+86-0571-88185666</phone>
    <email>64344308@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eye Hospital of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Man Hu, MD</last_name>
      <phone>13738069080</phone>
      <email>64344308@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Yune Zhao</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>anterior chamber parameters</keyword>
  <keyword>phacoemulsification</keyword>
  <keyword>anterior segment swept-source optical coherence tomography</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/NCT03779542
org study id: HM-AOD-HZ
nct id: NCT03779542
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To assess the changes of anterior chamber angle in patients with shallow anterior chamber and
      normal anterior chamber after phacoemulsification and intraocular lens implantation (IOL)
      using anterior segment swept-source optical coherence tomography (AS-SS-OCT).To observe the
      60 eyes of 60 patients in our study.
This is a prospective case-control study; 60 eyes of 60 patients who underwent cataract
      surgery. Based on anterior chamber depth (ACD) and gonioscopy findings, the eyes are
      classified into two groups, shallow anterior chamber group (30 eyes) and narrow anterior
      chamber group (30 eyes). AS-SS-OCT was used to measure ACD and angle parameters (angle
      opening distance(AOD), angle recess area(ARA), trabecular iris space area（TISA）, and
      trabecular iris angle (TIA). Serial changes in each group were measured before and 3 months
      after phacoemulsification and IOL, and the differences between the two groups were compared.
observational model: Case-Control
time perspective: Prospective
measure: anterior chamber depth
time frame: 1 year
arm group label: open-angle group
description: ACD > 2.68 measured by the swept source AS-OCT and angle > Shaffer 2 in four quadrants under gonioscope
arm group label: narrow-angle group
description: ACD≤2.68 measured by the swept source AS-OCT and angle≤Shaffer 2 in four quadrants under gonioscope
intervention type: Procedure
intervention name: cataract surgery
description: phacoemulsification and intraocular lens implantation
arm group label: narrow-angle group
arm group label: open-angle group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Man Hu, MD
phone: +86-0571-88185666
email: 64344308@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Yune Zhao
investigator title: Director