<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/NCT04416724</url>
  </required_header>
  <id_info>
    <org_study_id>CANPEX1</org_study_id>
    <nct_id>NCT04416724</nct_id>
  </id_info>
  <brief_title>Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma</brief_title>
  <acronym>CANPEX1</acronym>
  <official_title>Canadian Pseudoexfoliation Glaucoma Trial: Comparison of Phacoemulsification Versus Selective Laser Trabeculoplasty as Initial Treatment for Pseudoexfoliation Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jayme Vianna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glaucoma Research Society of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Glaucoma Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Canadian Pseudoexfoliation Glaucoma Study 1 is a randomized clinical trial that aims to&#xD;
      compare two initial treatment options - Selective Laser Trabeculoplasty (SLT) and&#xD;
      Phacoemulsification (PHACO) - in newly diagnosed patients with pseudoexfoliation and need to&#xD;
      lower the intraocular pressure. Patients with pseudoexfoliation and a recent decision to&#xD;
      lower the intraocular pressure, who also have early asymptomatic lens opacification will be&#xD;
      recruited and randomized to receive either SLT or PHACO. Patients will be followed for 2&#xD;
      years according to a target IOP protocol based on the Canadian Ophthalmological Society&#xD;
      Glaucoma guidelines. Patients who do not achieve the target IOP with the initial&#xD;
      randomization procedure will receive IOP lowering medications. The main outcome of interest&#xD;
      will be the proportion of subjects who need IOP lowering medications after 2 years. Secondary&#xD;
      outcomes include IOP reduction, time to need medications, patient reported outcomes in terms&#xD;
      of visual function, and occurrence of adverse effects. To obtain longer follow-up information&#xD;
      beyond two years, a chart review will be done 5 and 10 years after randomization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 2021</start_date>
  <completion_date type="Anticipated">August 2033</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>Medication-free intraocular pressure control</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of subjects without use of intraocular pressure lowering medications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication-free intraocular pressure control</measure>
    <time_frame>10 years</time_frame>
    <description>Proportion of subjects without use of intraocular pressure lowering medications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure change from baseline</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of intraocular pressure lowering medications</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to introduction of intraocular pressure lowering medications</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse effects</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score at the Glaucoma Quality of Life - 15</measure>
    <time_frame>10 years</time_frame>
    <description>The questionnaire GQL-15 was described in PMID: 12671469. The minimum value is 15 and the maximum is 75, with lower values indicating better quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pseudoexfoliation Glaucoma</condition>
  <arm_group>
    <arm_group_label>Phacoemulsification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Main study intervention will be Phacoemulsification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Main study intervention will be Selective Laser Trabeculoplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Phacoemulsification</intervention_name>
    <description>Lens removal by Phacoemulsification</description>
    <arm_group_label>Phacoemulsification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Selective Laser Trabeculoplasty</intervention_name>
    <description>Laser application in trabecular meshwork</description>
    <arm_group_label>SLT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material&#xD;
             on anterior capsule, pupil, or anterior chamber angle&#xD;
&#xD;
          2. Clinical decision to lower the IOP, as assessed by the investigator who is treating&#xD;
             the subject, based on the presence of PXG or with IOP elevated enough to warrant&#xD;
             treatment, even without clear evidence of optic nerve damage or visual field defect&#xD;
&#xD;
          3. Presence of asymptomatic early cataract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 50 years old&#xD;
&#xD;
          2. Anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum visible&#xD;
             in less than 180º&#xD;
&#xD;
          3. Previous IOP lowering procedure such as trabeculoplasty, trabeculectomy, or minimally&#xD;
             invasive glaucoma surgery&#xD;
&#xD;
          4. Previous use of IOP lowering medication for more than 6 months&#xD;
&#xD;
          5. Presence of ocular or systemic pathology or medication that could significantly&#xD;
             influence the IOP, such as: uveitis, neovascular or traumatic glaucoma, corneal&#xD;
             pathology influencing tonometry, use of oral steroids&#xD;
&#xD;
          6. IOP at baseline visit higher than 36 mmHg&#xD;
&#xD;
          7. Visual field damage at baseline visit with mean deviation worse than -15 dB&#xD;
&#xD;
          8. Not able or willing to provide voluntary, informed consent to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jayme Vianna, MD</last_name>
    <phone>1-902-473-3765</phone>
    <email>jayme.vianna@dal.ca</email>
  </overall_contact>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Jayme Vianna</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Exfoliation Syndrome</mesh_term>
  </condition_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/NCT04416724
org study id: CANPEX1
nct id: NCT04416724
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The Canadian Pseudoexfoliation Glaucoma Study 1 is a randomized clinical trial that aims to
      compare two initial treatment options - Selective Laser Trabeculoplasty (SLT) and
      Phacoemulsification (PHACO) - in newly diagnosed patients with pseudoexfoliation and need to
      lower the intraocular pressure. Patients with pseudoexfoliation and a recent decision to
      lower the intraocular pressure, who also have early asymptomatic lens opacification will be
      recruited and randomized to receive either SLT or PHACO. Patients will be followed for 2
      years according to a target IOP protocol based on the Canadian Ophthalmological Society
      Glaucoma guidelines. Patients who do not achieve the target IOP with the initial
      randomization procedure will receive IOP lowering medications. The main outcome of interest
      will be the proportion of subjects who need IOP lowering medications after 2 years. Secondary
      outcomes include IOP reduction, time to need medications, patient reported outcomes in terms
      of visual function, and occurrence of adverse effects. To obtain longer follow-up information
      beyond two years, a chart review will be done 5 and 10 years after randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Medication-free intraocular pressure control
time frame: 2 years
description: Proportion of subjects without use of intraocular pressure lowering medications
measure: Medication-free intraocular pressure control
time frame: 10 years
description: Proportion of subjects without use of intraocular pressure lowering medications
measure: Intraocular pressure change from baseline
time frame: 10 years
measure: Number of intraocular pressure lowering medications
time frame: 10 years
measure: Time to introduction of intraocular pressure lowering medications
time frame: 10 years
measure: Number of adverse effects
time frame: 10 years
measure: Score at the Glaucoma Quality of Life - 15
time frame: 10 years
description: The questionnaire GQL-15 was described in PMID: 12671469. The minimum value is 15 and the maximum is 75, with lower values indicating better quality of life.
arm group label: Phacoemulsification
arm group type: Experimental
description: Main study intervention will be Phacoemulsification
arm group label: SLT
arm group type: Experimental
description: Main study intervention will be Selective Laser Trabeculoplasty
intervention type: Procedure
intervention name: Phacoemulsification
description: Lens removal by Phacoemulsification
arm group label: Phacoemulsification
intervention type: Device
intervention name: Selective Laser Trabeculoplasty
description: Laser application in trabecular meshwork
arm group label: SLT
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Jayme Vianna, MD
phone: 1-902-473-3765
email: jayme.vianna@dal.ca
responsible party type: Sponsor-Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Jayme Vianna
investigator title: Principal Investigator
mesh term: Glaucoma
mesh term: Exfoliation Syndrome