<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/NCT04430296</url>
  </required_header>
  <id_info>
    <org_study_id>18/5/2020-1</org_study_id>
    <nct_id>NCT04430296</nct_id>
  </id_info>
  <brief_title>Cyclophotocoagulation in Primary Open Angle Glaucoma</brief_title>
  <official_title>Low Power Continuous Wave Versus Micro Pulse Diode Versus High Intensity Focused Ultrasound Cyclophotocoagulation in Primary Open Angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of Cyclodestruction procedures has been extended to patients with non-refractory&#xD;
      glaucoma and good vision. Our aim is to compare the safety and efﬁcacy of three&#xD;
      cyclodestructive treatments; High Intensity Focused Ultrasound (HIFU) Cyclocoagulation versus&#xD;
      micropulse cyclophotocoagulation (MP-CPC) versus transscleral continuous wave&#xD;
      cyclophotocoagulation (CW-CPC) for the treatment of Primary open angle glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate.</measure>
    <time_frame>6 months</time_frame>
    <description>The success will be defined as IOP between 6 and 21 mmHg and at least a 30% reduction in IOP with or without topical IOP lowering medications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of complications</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Primary Open Angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MicroPulse cyclophotocoagulation (MP-CPC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous Wave cyclophotocoagulation (CW-CPC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cyclophotocoagulation</intervention_name>
    <description>High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU): parameters: 21 MHz frequency, 2.45 W acoustic power, with the activation of each transducer lasting 6 seconds MicroPulse cyclophotocoagulation (MP-CPC):Laser settings of 2 Watts (W) will be applied for a 90 seconds treatment time for each 180 degrees, with a duty cycle of 31.3%, which consists of 0.5ms &quot;on time&quot; and 1.1 ms &quot;off-time&quot; and delivering a total of 112,7 Joules Continuous Wave cyclophotocoagulation (CW-CPC): The laser settings used will be 1.250 W, 4s exposure time per burn, 22-24 burns per eye.</description>
    <arm_group_label>Continuous Wave cyclophotocoagulation (CW-CPC)</arm_group_label>
    <arm_group_label>High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU)</arm_group_label>
    <arm_group_label>MicroPulse cyclophotocoagulation (MP-CPC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medically uncontrolled, primary open angle glaucoma attending glaucoma clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with history of previous laser or surgical intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed M Abdelrahman, MD</last_name>
    <phone>00201227394861</phone>
    <email>ahmed.mostafa@kasralainy.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heba M ElSaied, MD</last_name>
    <phone>00201224645060</phone>
    <email>hebamagdy13@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>abdussalam abdullatif, MD</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04430296
org study id: 18/5/2020-1
nct id: NCT04430296
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of Cyclodestruction procedures has been extended to patients with non-refractory
      glaucoma and good vision. Our aim is to compare the safety and efﬁcacy of three
      cyclodestructive treatments; High Intensity Focused Ultrasound (HIFU) Cyclocoagulation versus
      micropulse cyclophotocoagulation (MP-CPC) versus transscleral continuous wave
      cyclophotocoagulation (CW-CPC) for the treatment of Primary open angle glaucoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Success rate.
time frame: 6 months
description: The success will be defined as IOP between 6 and 21 mmHg and at least a 30% reduction in IOP with or without topical IOP lowering medications.
measure: Frequency of complications
time frame: 6 months
arm group label: High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU)
arm group type: Active Comparator
arm group label: MicroPulse cyclophotocoagulation (MP-CPC)
arm group type: Active Comparator
arm group label: Continuous Wave cyclophotocoagulation (CW-CPC)
arm group type: Active Comparator
intervention type: Procedure
intervention name: Cyclophotocoagulation
description: High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU): parameters: 21 MHz frequency, 2.45 W acoustic power, with the activation of each transducer lasting 6 seconds MicroPulse cyclophotocoagulation (MP-CPC):Laser settings of 2 Watts (W) will be applied for a 90 seconds treatment time for each 180 degrees, with a duty cycle of 31.3%, which consists of 0.5ms "on time" and 1.1 ms "off-time" and delivering a total of 112,7 Joules Continuous Wave cyclophotocoagulation (CW-CPC): The laser settings used will be 1.250 W, 4s exposure time per burn, 22-24 burns per eye.
arm group label: Continuous Wave cyclophotocoagulation (CW-CPC)
arm group label: High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU)
arm group label: MicroPulse cyclophotocoagulation (MP-CPC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ahmed M Abdelrahman, MD
phone: 00201227394861
email: ahmed.mostafa@kasralainy.edu.eg
last name: Heba M ElSaied, MD
phone: 00201224645060
email: hebamagdy13@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: abdussalam abdullatif, MD
investigator title: Lecturer
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: No