<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/NCT04419038</url>
  </required_header>
  <id_info>
    <org_study_id>81046</org_study_id>
    <nct_id>NCT04419038</nct_id>
  </id_info>
  <brief_title>Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium</brief_title>
  <official_title>Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ologen implantation with conjunctival autografting shows promising results in surgical&#xD;
      management of recurrent pterygium comparable to MMC application with conjunctival&#xD;
      autografting with mild non vision threatening postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who&#xD;
      underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2&#xD;
      mg/mL). Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with&#xD;
      Ologen implantation.&#xD;
&#xD;
      All patients had a recurrent nasal pterygium after one surgical session for removal of the&#xD;
      primary one. Any patient with primary nasal pterygium, or patients with recurrent pterygium&#xD;
      who had more than one session for surgical removal were excluded. As well, patients with&#xD;
      cicatrizing conjunctival disease or previous conjunctival surgery were excluded from the&#xD;
      study.&#xD;
&#xD;
      A comprehensive ophthalmic examination, including best-corrected visual acuity testing,&#xD;
      slit-lamp examination, Goldmann applanation tonometry, fundus examination, and examination of&#xD;
      ocular motility, was carried out for all patients. According to their corneal extent,&#xD;
      pterygia were classified into 3 grades:&#xD;
&#xD;
      Grade 1: Fibrovascular proliferations extend up to one quarter of the corneal diameter.&#xD;
&#xD;
      Grade 2: Fibrovascular proliferations extend up to the center of the cornea. Grade 3:&#xD;
      Fibrovascular proliferations extend beyond the visual axis.&#xD;
&#xD;
      Consents were taken from all patients and research was approved by the institutional review&#xD;
      board. All measures were in accordance with the tenets of the Declaration of Helsinki.&#xD;
&#xD;
      As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10&#xD;
      mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was&#xD;
      achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the&#xD;
      prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution). This&#xD;
      solution is stable for 2 weeks under refrigeration, and 24 hours at room temperature (59° to&#xD;
      86°F).&#xD;
&#xD;
      As for group B, 1×2 or 2×2 square millimeter porous collagen matrix was used for each patient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2016</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 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>32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).</measure>
    <time_frame>&quot;through study completion, an average of 1 year&quot;.</time_frame>
    <description>As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.</measure>
    <time_frame>&quot;through study completion, an average of 1 year&quot;.</time_frame>
    <description>In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Recurrent Pterygium of Eye</condition>
  <arm_group>
    <arm_group_label>conjunctival autografting with MMC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conjunctival autografting augmented with Ologen implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conjunctival autografting augmented with topical application of Mitomycin C</intervention_name>
    <description>Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).</description>
    <arm_group_label>conjunctival autografting augmented with Ologen implantation</arm_group_label>
    <arm_group_label>conjunctival autografting with MMC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conjunctival autografting augmented with Ologen implantation</intervention_name>
    <description>Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.</description>
    <arm_group_label>conjunctival autografting augmented with Ologen implantation</arm_group_label>
    <arm_group_label>conjunctival autografting with MMC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        recurrent nasal pterygium after one surgical session for removal of the primary one&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  primary nasal pterygium,&#xD;
&#xD;
          -  recurrent pterygium with more than one session for surgical removal&#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>June 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Menoufia University</investigator_affiliation>
    <investigator_full_name>Amin Faisal Ellakwa</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <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/NCT04419038
org study id: 81046
nct id: NCT04419038
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Ologen implantation with conjunctival autografting shows promising results in surgical
      management of recurrent pterygium comparable to MMC application with conjunctival
      autografting with mild non vision threatening postoperative complications.
Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who
      underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2
      mg/mL). Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with
      Ologen implantation.

      All patients had a recurrent nasal pterygium after one surgical session for removal of the
      primary one. Any patient with primary nasal pterygium, or patients with recurrent pterygium
      who had more than one session for surgical removal were excluded. As well, patients with
      cicatrizing conjunctival disease or previous conjunctival surgery were excluded from the
      study.

      A comprehensive ophthalmic examination, including best-corrected visual acuity testing,
      slit-lamp examination, Goldmann applanation tonometry, fundus examination, and examination of
      ocular motility, was carried out for all patients. According to their corneal extent,
      pterygia were classified into 3 grades:

      Grade 1: Fibrovascular proliferations extend up to one quarter of the corneal diameter.

      Grade 2: Fibrovascular proliferations extend up to the center of the cornea. Grade 3:
      Fibrovascular proliferations extend beyond the visual axis.

      Consents were taken from all patients and research was approved by the institutional review
      board. All measures were in accordance with the tenets of the Declaration of Helsinki.

      As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10
      mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was
      achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the
      prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution). This
      solution is stable for 2 weeks under refrigeration, and 24 hours at room temperature (59° to
      86°F).

      As for group B, 1×2 or 2×2 square millimeter porous collagen matrix was used for each patient
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
time frame: "through study completion, an average of 1 year".
description: As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution).
measure: 31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.
time frame: "through study completion, an average of 1 year".
description: In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)
arm group label: conjunctival autografting with MMC
arm group type: Active Comparator
description: Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
arm group label: conjunctival autografting augmented with Ologen implantation
arm group type: Active Comparator
description: Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
intervention type: Procedure
intervention name: conjunctival autografting augmented with topical application of Mitomycin C
description: Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
arm group label: conjunctival autografting augmented with Ologen implantation
arm group label: conjunctival autografting with MMC
intervention type: Procedure
intervention name: conjunctival autografting augmented with Ologen implantation
description: Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
arm group label: conjunctival autografting augmented with Ologen implantation
arm group label: conjunctival autografting with MMC
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Amin Faisal Ellakwa
investigator title: clinical professor
mesh term: Pterygium
mesh term: Recurrence
mesh term: Mitomycins
mesh term: Mitomycin