<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/NCT04417920</url>
  </required_header>
  <id_info>
    <org_study_id>late failure trabeculectomy</org_study_id>
    <nct_id>NCT04417920</nct_id>
  </id_info>
  <brief_title>Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy</brief_title>
  <official_title>Express Implant Versus Trabeculectomy in a Fibrotic Bleb With Late Failure After Previous Trabeculectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia 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 compare between outcome of Express implant and subscleral trabeculectomy (SST) in&#xD;
      management of glaucoma after previous trabeculectomy with a fibrotic bleb.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trabeculectomy is the main glaucoma surgery. Despite the good decline in intraocular pressure&#xD;
      (IOP) that occur rapidly after the procedure, there is still failure occurring due to&#xD;
      progressive subconjunctival fibrosis, with associated increased IOP.&#xD;
&#xD;
      If the bleb is revived by needling with adjunctive 5-fluorouracil (5FU) and mitomycin C (MMC)&#xD;
      that used intraoperatively for the majority of these cases , the associated rise in IOP was&#xD;
      controlled if the revision occured early within the first three months after surgery. But&#xD;
      less success occurred if the bleb revision was delayed.&#xD;
&#xD;
      If these interventions fail, alternative approaches include new augmented trabeculectomy or&#xD;
      aqueous shunt implantation.&#xD;
&#xD;
      Express shunt allows aqueous to pass from anterior chamber to subconjunctival space like&#xD;
      trabeculectomy .Express shunt is a non valved shunt, It has an advantage of less traumatic,&#xD;
      less complications, low diffuse bleb and high success rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">May 20, 2020</completion_date>
  <primary_completion_date type="Actual">May 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of intra ocular pressure (IOP)</measure>
    <time_frame>one year follow up</time_frame>
    <description>IOP measured with Goldmann applanation tonometry:&#xD;
Complete success in IOP considered as IOP less than 20 mmHg without treatment and a qualified success in IOP considered as IOP less than 20 mmHg with medical treatment and a failure in IOP control considered if IOP more than or equal 20 mmHg after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity changes by Decimal</measure>
    <time_frame>one year follow up</time_frame>
    <description>glaucoma changes follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glaucomatous visual field (VF) changes in median deviation by decibels (dB)</measure>
    <time_frame>one year follow up</time_frame>
    <description>glaucoma changes follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in optic Cup-to-Disc ratio by Volk+90 non-contact lens</measure>
    <time_frame>one year follow up</time_frame>
    <description>glaucoma changes follow up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>group I (Express implant)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group II (trabeculectomy)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock.&#xD;
conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of sclerectomy and peripheral iridectomy and closed scleral flab and conjunctiva by nylon 10/0 sutures</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Express implant device</intervention_name>
    <description>Operative technique in group I (Express implant) was as in group II (trabeculectomy) except with no sclerectomy or peripheral iridectomy , the steps included conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva.&#xD;
While in group II, Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock.</description>
    <arm_group_label>group I (Express implant)</arm_group_label>
    <arm_group_label>group II (trabeculectomy)</arm_group_label>
    <other_name>Trabeculectomy with Mitomycin-C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elevated intraocular pressure (IOP) with fibrotic bleb despite previous SST since more&#xD;
             than 4 months&#xD;
&#xD;
          -  follow up 12mo after the second surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  SST failure other than fibrotic bleb were also excluded&#xD;
&#xD;
          -  follow up less than 4mo after the first surgery, and those less than 12mo after the&#xD;
             second surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faried Wagdy, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Gamal Abd El Nasr st. - Shebin ElKoum - Menofia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tharwat Mokbel</name>
      <address>
        <city>Mansoura</city>
        <state>AlDakahlia</state>
        <zip>35511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 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>Ahmed Alnagdy</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Express valve</keyword>
  <keyword>Failed Trabeculectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04417920
org study id: late failure trabeculectomy
nct id: NCT04417920
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare between outcome of Express implant and subscleral trabeculectomy (SST) in
      management of glaucoma after previous trabeculectomy with a fibrotic bleb.
Trabeculectomy is the main glaucoma surgery. Despite the good decline in intraocular pressure
      (IOP) that occur rapidly after the procedure, there is still failure occurring due to
      progressive subconjunctival fibrosis, with associated increased IOP.

      If the bleb is revived by needling with adjunctive 5-fluorouracil (5FU) and mitomycin C (MMC)
      that used intraoperatively for the majority of these cases , the associated rise in IOP was
      controlled if the revision occured early within the first three months after surgery. But
      less success occurred if the bleb revision was delayed.

      If these interventions fail, alternative approaches include new augmented trabeculectomy or
      aqueous shunt implantation.

      Express shunt allows aqueous to pass from anterior chamber to subconjunctival space like
      trabeculectomy .Express shunt is a non valved shunt, It has an advantage of less traumatic,
      less complications, low diffuse bleb and high success rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change of intra ocular pressure (IOP)
time frame: one year follow up
description: IOP measured with Goldmann applanation tonometry:
Complete success in IOP considered as IOP less than 20 mmHg without treatment and a qualified success in IOP considered as IOP less than 20 mmHg with medical treatment and a failure in IOP control considered if IOP more than or equal 20 mmHg after surgery
measure: Visual acuity changes by Decimal
time frame: one year follow up
description: glaucoma changes follow up
measure: Glaucomatous visual field (VF) changes in median deviation by decibels (dB)
time frame: one year follow up
description: glaucoma changes follow up
measure: Changes in optic Cup-to-Disc ratio by Volk+90 non-contact lens
time frame: one year follow up
description: glaucoma changes follow up
arm group label: group I (Express implant)
arm group type: Active Comparator
description: conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva
arm group label: group II (trabeculectomy)
arm group type: Active Comparator
description: Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock.
conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of sclerectomy and peripheral iridectomy and closed scleral flab and conjunctiva by nylon 10/0 sutures
intervention type: Procedure
intervention name: Express implant device
description: Operative technique in group I (Express implant) was as in group II (trabeculectomy) except with no sclerectomy or peripheral iridectomy , the steps included conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva.
While in group II, Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock.
arm group label: group I (Express implant)
arm group label: group II (trabeculectomy)
other name: Trabeculectomy with Mitomycin-C
criteria: 
gender: All
minimum age: 42 Years
maximum age: 55 Years
healthy volunteers: No
last name: Faried Wagdy, Prof.
role: Study Chair
affiliation: Gamal Abd El Nasr st. - Shebin ElKoum - Menofia
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Ahmed Alnagdy
investigator title: Director
mesh term: Glaucoma
mesh term: Mitomycins
mesh term: Mitomycin
sharing ipd: Undecided