<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/NCT04463901</url>
  </required_header>
  <id_info>
    <org_study_id>20150527</org_study_id>
    <nct_id>NCT04463901</nct_id>
  </id_info>
  <brief_title>Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C</brief_title>
  <official_title>Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized clinical trial is to compare the efficacy and safety of&#xD;
      intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or&#xD;
      conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also&#xD;
      evaluate particular risk factors related to pterygium recurrence&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of&#xD;
      recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the&#xD;
      bare sclera will efficiently reduce postoperative longstanding epithelial defect.&#xD;
&#xD;
      Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision&#xD;
      followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival&#xD;
      autograft .The patients will be followed at least 12 months. Corneal recurrence is considered&#xD;
      as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous&#xD;
      pterygium excision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of pterygium</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healing time of corneal epithelium</measure>
    <time_frame>Four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healing time of conjunctival epithelium</measure>
    <time_frame>Four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Recurrent Pterygium</condition>
  <arm_group>
    <arm_group_label>Group CAG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then conjunctival autograft without limbal tissue will be used to cover the bare sclera.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group LCAG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft will be used to cover the bare sclera.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pterygium excision</intervention_name>
    <description>Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.</description>
    <arm_group_label>Group CAG</arm_group_label>
    <arm_group_label>Group LCAG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraoperative mitomycin C</intervention_name>
    <description>Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.</description>
    <arm_group_label>Group CAG</arm_group_label>
    <arm_group_label>Group LCAG</arm_group_label>
    <other_name>MMC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conjunctival autograft</intervention_name>
    <description>A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.</description>
    <arm_group_label>Group CAG</arm_group_label>
    <other_name>CAG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Limbal conjunctival autograft</intervention_name>
    <description>A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.</description>
    <arm_group_label>Group LCAG</arm_group_label>
    <other_name>LCAG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recurrent pterygium&#xD;
&#xD;
          -  Willingness to participate in research project and to attend research time&#xD;
&#xD;
          -  At least 6 months after last pterygium surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant,breast-feeding women or poor general health&#xD;
&#xD;
          -  Patients with significant ocular or lid pathology, such as Sjogren's Syndrome&#xD;
             ,infection, exposure keratitis,glaucoma and trauma&#xD;
&#xD;
          -  Patients with allergy to mitomycin C,tobramycin or local anesthetics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhou Shiyou, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhou Shiyou, M.D., Ph.D.</last_name>
    <phone>86-02087331540</phone>
    <email>zhoushiy@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhou Tao, M.D.</last_name>
    <phone>86-18126813938</phone>
    <email>taochou_tony@foxmail.com</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiyou Zhou, M.D., Ph.D.</last_name>
      <phone>86-02087331550</phone>
      <email>zhoushiy@mail.sysu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Tao Zhou, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 4, 2020</last_update_submitted>
  <last_update_submitted_qc>July 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 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>Shiyou Zhou</investigator_full_name>
    <investigator_title>MD,PhD</investigator_title>
  </responsible_party>
  <keyword>recurrent pterygium</keyword>
  <keyword>pterygium</keyword>
  <keyword>limbal conjunctival autograft</keyword>
  <keyword>conjunctival autograft</keyword>
  <keyword>mitomycin c</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pterygium</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</mesh_term>
  </intervention_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/NCT04463901
org study id: 20150527
nct id: NCT04463901
lead sponsor: 
has dmc: Yes
The purpose of this randomized clinical trial is to compare the efficacy and safety of
      intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or
      conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also
      evaluate particular risk factors related to pterygium recurrence
Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of
      recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the
      bare sclera will efficiently reduce postoperative longstanding epithelial defect.

      Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision
      followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival
      autograft .The patients will be followed at least 12 months. Corneal recurrence is considered
      as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous
      pterygium excision.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Recurrence of pterygium
time frame: One year
measure: Visual acuity
time frame: One year
measure: Healing time of corneal epithelium
time frame: Four weeks
measure: Healing time of conjunctival epithelium
time frame: Four weeks
measure: Postoperative complications
time frame: One year
arm group label: Group CAG
arm group type: Active Comparator
description: After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then conjunctival autograft without limbal tissue will be used to cover the bare sclera.
arm group label: Group LCAG
arm group type: Active Comparator
description: After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft will be used to cover the bare sclera.
intervention type: Procedure
intervention name: Pterygium excision
description: Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.
arm group label: Group CAG
arm group label: Group LCAG
intervention type: Procedure
intervention name: Intraoperative mitomycin C
description: Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
arm group label: Group CAG
arm group label: Group LCAG
other name: MMC
intervention type: Procedure
intervention name: Conjunctival autograft
description: A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
arm group label: Group CAG
other name: CAG
intervention type: Procedure
intervention name: Limbal conjunctival autograft
description: A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
arm group label: Group LCAG
other name: LCAG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhou Shiyou, M.D., Ph.D.
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
last name: Zhou Shiyou, M.D., Ph.D.
phone: 86-02087331540
email: zhoushiy@mail.sysu.edu.cn
last name: Zhou Tao, M.D.
phone: 86-18126813938
email: taochou_tony@foxmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Shiyou Zhou
investigator title: MD,PhD
mesh term: Pterygium
mesh term: Recurrence
mesh term: Mitomycins
mesh term: Mitomycin