<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/NCT02238015</url>
  </required_header>
  <id_info>
    <org_study_id>WZMC2013BNZYJ</org_study_id>
    <nct_id>NCT02238015</nct_id>
  </id_info>
  <brief_title>Tear Film Evaluation After Phacoemulsification</brief_title>
  <acronym>TFAP</acronym>
  <official_title>To Investigate Tear Film Change After Phacoemulsification With SS-OCT</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare tear film differences between surgical eyes and nonsurgical eyes in patients who&#xD;
      had cataract surgery by phacoemulsification in one eye.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants granted their written informed consent to participate in the research&#xD;
      protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 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>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Phacoemulsification influence on the postoperative tear functions</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cortical Senile Cataract</condition>
  <arm_group>
    <arm_group_label>surgery group</arm_group_label>
    <description>patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>patients' other eye that did not have surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cataract surgery</intervention_name>
    <description>All patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye</description>
    <arm_group_label>surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        60 eyes from 30 age-related cataract participants underwent cataract surgery with 3.0 mm&#xD;
        clear corneal incision at 11 o'clock in one eye and the other eye without surgery history&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        age-related cataract without surgery history and dry eye symptoms history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        diseases influencing tear secretion (such as Sjögren syndrome, Steve-Johnson syndrome,&#xD;
        diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness IV and V,&#xD;
        which required the use of larger phacoemulsification energy; use of drugs that affect tear&#xD;
        secretion and stability (such as glaucoma medications, artificial tears, corticosteroid&#xD;
        drugs, etc.); or presence of ocular diseases (such as Pterygium, blepharitis, uveitis,&#xD;
        glaucoma, lacrimal apparatus, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qian Zheng, 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>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, MD</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>cataract ,tear film,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/NCT02238015
org study id: WZMC2013BNZYJ
nct id: NCT02238015
lead sponsor: 
has dmc: Yes
To compare tear film differences between surgical eyes and nonsurgical eyes in patients who
      had cataract surgery by phacoemulsification in one eye.
All participants granted their written informed consent to participate in the research
      protocol.
observational model: Case-Control
time perspective: Prospective
measure: Phacoemulsification influence on the postoperative tear functions
time frame: 1 year
arm group label: surgery group
description: patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye
arm group label: control group
description: patients' other eye that did not have surgery
intervention type: Procedure
intervention name: cataract surgery
description: All patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye
arm group label: surgery group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Qian Zheng, 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