<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/NCT04400097</url>
  </required_header>
  <id_info>
    <org_study_id>SHAIER2020IRB03</org_study_id>
    <nct_id>NCT04400097</nct_id>
  </id_info>
  <brief_title>The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium</brief_title>
  <official_title>The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aier School of Ophthalmology, Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aier School of Ophthalmology, Central South 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 evaluate the efficacy and effect on patient comfort of a hidden-knot continuous suture for&#xD;
      pterygium excision with conjunctival autograft，compared with two-knot continuous sutures and&#xD;
      multi-knot interrupted sutures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 21, 2020</start_date>
  <completion_date type="Anticipated">December 21, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 21, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient comfort</measure>
    <time_frame>6 months</time_frame>
    <description>discomfort grading on a visual analog scale</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft</condition>
  <arm_group>
    <arm_group_label>hidden-knot group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>two-knot group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>multi-knot group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>suture</intervention_name>
    <description>suture methods of autograft conjunctival transplantation</description>
    <arm_group_label>hidden-knot group</arm_group_label>
    <arm_group_label>multi-knot group</arm_group_label>
    <arm_group_label>two-knot group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with primary pterygium&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  eye surgery history&#xD;
&#xD;
          -  acute ocular surface imflamation&#xD;
&#xD;
          -  patients with coagulation or diabetes mellitus&#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_contact>
    <last_name>Yan Chen, doctor</last_name>
    <phone>+86-021-62956699</phone>
    <email>chinacy@hotmail.com</email>
  </overall_contact>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 20, 2020</last_update_submitted>
  <last_update_submitted_qc>May 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pterygium</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/NCT04400097
org study id: SHAIER2020IRB03
nct id: NCT04400097
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy and effect on patient comfort of a hidden-knot continuous suture for
      pterygium excision with conjunctival autograft，compared with two-knot continuous sutures and
      multi-knot interrupted sutures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Patient comfort
time frame: 6 months
description: discomfort grading on a visual analog scale
arm group label: hidden-knot group
arm group type: Experimental
arm group label: two-knot group
arm group type: Active Comparator
arm group label: multi-knot group
arm group type: Active Comparator
intervention type: Procedure
intervention name: suture
description: suture methods of autograft conjunctival transplantation
arm group label: hidden-knot group
arm group label: multi-knot group
arm group label: two-knot group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yan Chen, doctor
phone: +86-021-62956699
email: chinacy@hotmail.com
responsible party type: Sponsor
mesh term: Pterygium
sharing ipd: No