<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/NCT04493073</url>
  </required_header>
  <id_info>
    <org_study_id>OCTA after Trabeculectomy</org_study_id>
    <nct_id>NCT04493073</nct_id>
  </id_info>
  <brief_title>Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy</brief_title>
  <official_title>Comparison of Conjunctival Vascularity Changes Using Optical Coherence Tomography Angiography After Trabeculectomy With Mitomycin and Ologen Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asmaa Ahmed Ali Youssif</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>
      -  Reduce the trauma and the time taken for patient rehabilitation.&#xD;
&#xD;
        -  The prevailing trend is to perform a mitomycin- C (MMC)-augmented trabeculectomy and&#xD;
           trabeculectomy with ologen implants in a trial to decrease bleb failure as a common&#xD;
           post- trabeculectomy complication.&#xD;
&#xD;
        -  Is to develop a measurement protocol by OCT-A imaging and characterization of the bleb&#xD;
           vascularity changes in glaucoma patients before and after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this project is to compare bleb vascularity changes using optical&#xD;
      coherence tomography (OCT-A) between mitomycin- C (MMC)-augmented trabeculectomy and develop&#xD;
      trabeculectomy with ologen implants to determine whether bleb vascularity measurements during&#xD;
      preoperative and early postoperative periode could act as surrogate parameters to predict&#xD;
      surgical outcomes.&#xD;
&#xD;
      Glaucoma often existent in the elderly population. Measuremets of bleb vascularity beginning&#xD;
      to become an essential part of the glaucoma specialist's clinical and operative took. As&#xD;
      investigators continue to collect data both clinically and in the laboratory, these various&#xD;
      imaging modalities will shepherd surgeons into a more precise and predicable era of glaucoma&#xD;
      surgeries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>conjunctival vascularity changes</measure>
    <time_frame>1 year</time_frame>
    <description>conjunctival vascularity changes using OCTA</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>OCTA</condition>
  <arm_group>
    <arm_group_label>Trabectulectomy with mitomycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trabectulectomy with Ologen implants</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ologen Collagen Implant (Aeon Astron Europe, Netherlands) - three-dimensional collagen- GAG implant &gt;90% lyophilized porcine atelocollagen and &lt;10% lyophilized porcine GAG 12 mm in diameter with 1 mm of thickness and 6 mm in diameter with 2 mm of thickness</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trabectulectomy</intervention_name>
    <description>decrease IOP</description>
    <arm_group_label>Trabectulectomy with Ologen implants</arm_group_label>
    <arm_group_label>Trabectulectomy with mitomycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitomycin</intervention_name>
    <description>Decrease bleb failure</description>
    <arm_group_label>Trabectulectomy with mitomycin</arm_group_label>
    <other_name>ologen implants</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ologen Collagen Implant</intervention_name>
    <description>Ologen Collagen Implant (Aeon Astron Europe, Netherlands)</description>
    <arm_group_label>Trabectulectomy with Ologen implants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mitomycin-C Kyowa®</intervention_name>
    <description>Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)</description>
    <arm_group_label>Trabectulectomy with mitomycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients older than 18 years of age with primary or secondary open-angle glaucoma.&#xD;
&#xD;
          -  Primary OAG (POAG) diagnosed on the basis of IOP measurements more than 21 mmHg, open&#xD;
             angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width),&#xD;
             glaucomatous visual field defects consistent with glaucomatous optic disc changes.&#xD;
&#xD;
          -  PNAG was diagnosed by the presence of narrow or occludable angle on gonioscopy (Grade&#xD;
             2, or 1 on Schaffer grading system for angle width in at least 180° of the total&#xD;
             circumference of the angle in primary position without indentation), glaucomatous&#xD;
             optic disc changes, visual field defects and IOP more than 21 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or lactating female.&#xD;
&#xD;
          -  previous intraocular surgery&#xD;
&#xD;
          -  one-eyed patients.&#xD;
&#xD;
          -  previous ocular trauma.&#xD;
&#xD;
          -  uveitis-induced glaucoma, neovascular glaucoma, aphakic/pseudophakic glaucoma&#xD;
&#xD;
          -  systemic connective tissue disease and missing more than 3 follow-up visits.&#xD;
&#xD;
          -  Trabeculectomy augmented by either MMC or Ologen implant was indicated to study&#xD;
             subjects if they had uncontrolled IOP under maximum antiglaucoma medications (3&#xD;
             antiglaucoma drugs) or due to poor socioeconomic status.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Saad</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asmaa Ali, PhD</last_name>
    <phone>01002475442</phone>
    <email>asmaaahmedali@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Khaled Abd El azzem, PhD</last_name>
    <phone>01114001717</phone>
  </overall_contact_backup>
  <reference>
    <citation>He M, Wang W, Zhang X, Huang W. Ologen implant versus mitomycin C for trabeculectomy: a systematic review and meta-analysis. PLoS One. 2014 Jan 20;9(1):e85782. doi: 10.1371/journal.pone.0085782. eCollection 2014.</citation>
    <PMID>24465704</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Asmaa Ahmed Ali Youssif</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <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/NCT04493073
org study id: OCTA after Trabeculectomy
nct id: NCT04493073
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
-  Reduce the trauma and the time taken for patient rehabilitation.

        -  The prevailing trend is to perform a mitomycin- C (MMC)-augmented trabeculectomy and
           trabeculectomy with ologen implants in a trial to decrease bleb failure as a common
           post- trabeculectomy complication.

        -  Is to develop a measurement protocol by OCT-A imaging and characterization of the bleb
           vascularity changes in glaucoma patients before and after surgery.
The main purpose of this project is to compare bleb vascularity changes using optical
      coherence tomography (OCT-A) between mitomycin- C (MMC)-augmented trabeculectomy and develop
      trabeculectomy with ologen implants to determine whether bleb vascularity measurements during
      preoperative and early postoperative periode could act as surrogate parameters to predict
      surgical outcomes.

      Glaucoma often existent in the elderly population. Measuremets of bleb vascularity beginning
      to become an essential part of the glaucoma specialist's clinical and operative took. As
      investigators continue to collect data both clinically and in the laboratory, these various
      imaging modalities will shepherd surgeons into a more precise and predicable era of glaucoma
      surgeries.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Investigator)
measure: conjunctival vascularity changes
time frame: 1 year
description: conjunctival vascularity changes using OCTA
arm group label: Trabectulectomy with mitomycin
arm group type: Active Comparator
description: Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration
arm group label: Trabectulectomy with Ologen implants
arm group type: Active Comparator
description: Ologen Collagen Implant (Aeon Astron Europe, Netherlands) - three-dimensional collagen- GAG implant >90% lyophilized porcine atelocollagen and <10% lyophilized porcine GAG 12 mm in diameter with 1 mm of thickness and 6 mm in diameter with 2 mm of thickness
intervention type: Procedure
intervention name: Trabectulectomy
description: decrease IOP
arm group label: Trabectulectomy with Ologen implants
arm group label: Trabectulectomy with mitomycin
intervention type: Drug
intervention name: Mitomycin
description: Decrease bleb failure
arm group label: Trabectulectomy with mitomycin
other name: ologen implants
intervention type: Device
intervention name: Ologen Collagen Implant
description: Ologen Collagen Implant (Aeon Astron Europe, Netherlands)
arm group label: Trabectulectomy with Ologen implants
intervention type: Device
intervention name: Mitomycin-C Kyowa®
description: Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)
arm group label: Trabectulectomy with mitomycin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed Saad
role: Study Director
affiliation: Assiut University
last name: Asmaa Ali, PhD
phone: 01002475442
email: asmaaahmedali@yahoo.com
last name: Khaled Abd El azzem, PhD
phone: 01114001717
citation: He M, Wang W, Zhang X, Huang W. Ologen implant versus mitomycin C for trabeculectomy: a systematic review and meta-analysis. PLoS One. 2014 Jan 20;9(1):e85782. doi: 10.1371/journal.pone.0085782. eCollection 2014.
PMID: 24465704
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Asmaa Ahmed Ali Youssif
investigator title: doctor
mesh term: Mitomycins
mesh term: Mitomycin