<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/NCT04476810</url>
  </required_header>
  <id_info>
    <org_study_id>IRB -2020-01-169</org_study_id>
    <nct_id>NCT04476810</nct_id>
  </id_info>
  <brief_title>Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade</brief_title>
  <official_title>Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmed Al Habash</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imam Abdulrahman Bin Faisal 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>
      Purpose: Characterize changes in intraocular pressure (IOP), IOP-lowering medications, and&#xD;
      visual acuity (VA) through 3 years in patients undergoing combined phacoemulsification and&#xD;
      excisional goniotomy with the Kahook Dual Blade (phaco-KDB), with simultaneous&#xD;
      goniosynechialysis in cases of angle-closure glaucoma, by a single surgeon (A.H.) in King&#xD;
      Fahd Hospital of the University, Dammam, Saudi Arabia.&#xD;
&#xD;
      Methods: Prospective, non-comparative, uncontrolled, non-randomized interventional case&#xD;
      series. Consecutive patients with medically-treated glaucoma and visually-significant&#xD;
      cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>36 months</time_frame>
    <description>Characterize changes in intraocular pressure (IOP) in mmHg goldmann applanation tonometry each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraocular pressure lowering medications</measure>
    <time_frame>36 months</time_frame>
    <description>count the change in number of Intraocular pressure lowering medications each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>36 months</time_frame>
    <description>Characterize visual acuity (VA) using logMAR chart, each visit in clinic post undergoing combined phacoemulsification and excisional goniotomy with the kahook dual blade.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Glaucoma</condition>
  <condition>Glaucoma, Open-Angle</condition>
  <condition>Cataract</condition>
  <condition>Angle Closure Glaucoma</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>combined (phaco-kdb)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>kahook dual blade</intervention_name>
    <description>Combined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade</description>
    <arm_group_label>combined (phaco-kdb)</arm_group_label>
    <other_name>phacoemulsification</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria:&#xD;
&#xD;
          -  adults 18 years or older&#xD;
&#xD;
          -  medically-managed glaucoma&#xD;
&#xD;
          -  visually significant cataract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing any other combined procedures&#xD;
&#xD;
          -  active uveitis&#xD;
&#xD;
          -  coexisting retinopathy that limits visual acuity potential&#xD;
&#xD;
          -  active neovascularization&#xD;
&#xD;
          -  angle dysgenesis&#xD;
&#xD;
          -  those with less than 6 months of follow-up, were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Al habash, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>assistant professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imam Abdulrahman Bin Faisal University Hospital</name>
      <address>
        <city>Dammam</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Imam Abdulrahman Bin Faisal University</investigator_affiliation>
    <investigator_full_name>Ahmed Al Habash</investigator_full_name>
    <investigator_title>Dr. Ahmed Al Habash, MD assistant professor, consultant cataract and glaucoma</investigator_title>
  </responsible_party>
  <keyword>glaucoma</keyword>
  <keyword>goniotomy</keyword>
  <keyword>Kahook Dual Blade</keyword>
  <keyword>combined phacoemulsification</keyword>
  <keyword>MIGS</keyword>
  <keyword>Schlemm's Canal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Glaucoma, Angle-Closure</mesh_term>
  </condition_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/NCT04476810
org study id: IRB -2020-01-169
nct id: NCT04476810
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Purpose: Characterize changes in intraocular pressure (IOP), IOP-lowering medications, and
      visual acuity (VA) through 3 years in patients undergoing combined phacoemulsification and
      excisional goniotomy with the Kahook Dual Blade (phaco-KDB), with simultaneous
      goniosynechialysis in cases of angle-closure glaucoma, by a single surgeon (A.H.) in King
      Fahd Hospital of the University, Dammam, Saudi Arabia.

      Methods: Prospective, non-comparative, uncontrolled, non-randomized interventional case
      series. Consecutive patients with medically-treated glaucoma and visually-significant
      cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
primary purpose: Treatment
masking: None (Open Label)
measure: Intraocular pressure
time frame: 36 months
description: Characterize changes in intraocular pressure (IOP) in mmHg goldmann applanation tonometry each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade.
measure: Intraocular pressure lowering medications
time frame: 36 months
description: count the change in number of Intraocular pressure lowering medications each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade
measure: Visual acuity
time frame: 36 months
description: Characterize visual acuity (VA) using logMAR chart, each visit in clinic post undergoing combined phacoemulsification and excisional goniotomy with the kahook dual blade.
arm group label: combined (phaco-kdb)
arm group type: Experimental
description: Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
intervention type: Device
intervention name: kahook dual blade
description: Combined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade
arm group label: combined (phaco-kdb)
other name: phacoemulsification
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Al habash, MD
role: Principal Investigator
affiliation: assistant professor
facility: 
country: Saudi Arabia
responsible party type: Sponsor-Investigator
investigator affiliation: Imam Abdulrahman Bin Faisal University
investigator full name: Ahmed Al Habash
investigator title: Dr. Ahmed Al Habash, MD assistant professor, consultant cataract and glaucoma
mesh term: Glaucoma
mesh term: Cataract
mesh term: Glaucoma, Open-Angle
mesh term: Glaucoma, Angle-Closure
sharing ipd: Undecided