<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/NCT03301974</url>
  </required_header>
  <id_info>
    <org_study_id>17200138</org_study_id>
    <nct_id>NCT03301974</nct_id>
  </id_info>
  <brief_title>A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery</brief_title>
  <official_title>A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea&#xD;
      with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium&#xD;
      is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which&#xD;
      compromises outcomes. Based on the simple excision of pterygium, multiple strategies and&#xD;
      techniques have been developed to reduce the high rate of pterygium recurrence. The&#xD;
      investigators aim was to compare the safety, efficacy, overall patient satisfaction and&#xD;
      recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching&#xD;
      conjunctival autograft in primary pterygium surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: Prospective randomized comparative interventional clinical study Setting: Assiut&#xD;
      university hospital &amp; El-Mabarah hospital for health insurance Methods: The study included 60&#xD;
      eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple&#xD;
      excision under local anesthesia was performed then closure of the bare sclera by conjunctival&#xD;
      autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free&#xD;
      conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free&#xD;
      conjunctival autograft in 20 eyes of 20 patients (group 3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 24, 2019</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence Rate</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>The main postoperative primary outcomes measure the recurrence rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Graft stability</measure>
    <time_frame>1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively</time_frame>
    <description>postoperative Graft stability rated from grade 0 to 4 using a 5 point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative inflammation</measure>
    <time_frame>1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively</time_frame>
    <description>postoperative inflammation rated from grade 0 to 4 using a 5 point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative discomfort</measure>
    <time_frame>1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively</time_frame>
    <description>postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patient satisfaction</measure>
    <time_frame>1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively</time_frame>
    <description>Overall satisfaction with the procedure 4 weeks post-operatively will recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The three groups will compared for overall satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively</time_frame>
    <description>Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pterygium</condition>
  <arm_group>
    <arm_group_label>conjunctival autograft with fibrin glue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sutured conjunctival autograft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sutured conjunctival autograft done for patients of group 2 after pterygium excision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sutureless and glue-free conjunctival autograft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conjunctival autograft with fibrin glue</intervention_name>
    <description>Simple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1).</description>
    <arm_group_label>conjunctival autograft with fibrin glue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sutured conjunctival autograft</intervention_name>
    <description>Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2).</description>
    <arm_group_label>sutured conjunctival autograft</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sutureless and glue-free conjunctival autograft</intervention_name>
    <description>Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)</description>
    <arm_group_label>sutureless and glue-free conjunctival autograft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients complaining of primary Progressive nasal pterygium.&#xD;
&#xD;
          2. Patients with pterygium threatening the visual axis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Double head pterygium.&#xD;
&#xD;
          2. Pseudopterygium&#xD;
&#xD;
          3. Recurrent pterygium&#xD;
&#xD;
          4. Patients with history of any bleeding abnormalities&#xD;
&#xD;
          5. Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Fathy Ahmed Oraby</investigator_full_name>
    <investigator_title>Specialist of ophthalmology, El-Mabarah hospital for Health insurance, Assuit, Egypt</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pterygium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin Tissue Adhesive</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/NCT03301974
org study id: 17200138
nct id: NCT03301974
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea
      with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium
      is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which
      compromises outcomes. Based on the simple excision of pterygium, multiple strategies and
      techniques have been developed to reduce the high rate of pterygium recurrence. The
      investigators aim was to compare the safety, efficacy, overall patient satisfaction and
      recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching
      conjunctival autograft in primary pterygium surgery.
Design: Prospective randomized comparative interventional clinical study Setting: Assiut
      university hospital & El-Mabarah hospital for health insurance Methods: The study included 60
      eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple
      excision under local anesthesia was performed then closure of the bare sclera by conjunctival
      autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free
      conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free
      conjunctival autograft in 20 eyes of 20 patients (group 3).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Recurrence Rate
time frame: 6 months postoperatively
description: The main postoperative primary outcomes measure the recurrence rate
measure: Graft stability
time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
description: postoperative Graft stability rated from grade 0 to 4 using a 5 point scale
measure: Postoperative inflammation
time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
description: postoperative inflammation rated from grade 0 to 4 using a 5 point scale
measure: Postoperative discomfort
time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
description: postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)
measure: Overall patient satisfaction
time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
description: Overall satisfaction with the procedure 4 weeks post-operatively will recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The three groups will compared for overall satisfaction.
measure: Complications
time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
description: Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.
arm group label: conjunctival autograft with fibrin glue
arm group type: Experimental
description: Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
arm group label: sutured conjunctival autograft
arm group type: Experimental
description: Sutured conjunctival autograft done for patients of group 2 after pterygium excision
arm group label: sutureless and glue-free conjunctival autograft
arm group type: Experimental
description: Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision
intervention type: Procedure
intervention name: conjunctival autograft with fibrin glue
description: Simple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1).
arm group label: conjunctival autograft with fibrin glue
intervention type: Procedure
intervention name: sutured conjunctival autograft
description: Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2).
arm group label: sutured conjunctival autograft
intervention type: Procedure
intervention name: sutureless and glue-free conjunctival autograft
description: Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)
arm group label: sutureless and glue-free conjunctival autograft
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Fathy Ahmed Oraby
investigator title: Specialist of ophthalmology, El-Mabarah hospital for Health insurance, Assuit, Egypt
mesh term: Pterygium
mesh term: Fibrin Tissue Adhesive