<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/NCT02231515</url>
  </required_header>
  <id_info>
    <org_study_id>1219</org_study_id>
    <nct_id>NCT02231515</nct_id>
  </id_info>
  <brief_title>Prospective,Randomized,Controlled Study to Assess Efficacy,Safety, and Tolerability of SLT vs. PLT in Patients With POAG</brief_title>
  <official_title>A Prospective, Randomized, Controlled Study to Assess Efficacy,Safety, and Tolerability of Selective Laser Trabeculoplasty vs. Pattern Laser Trabeculoplasty in Patients With Open-angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of&#xD;
      selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with open-angle&#xD;
      glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomised, controlled study. Patients will be selected for this study&#xD;
      who require bilateral laser trabeculoplasty for IOP control. Eyes will undergo a medication&#xD;
      wash-out 4 weeks prior to the baseline study session (S1). There will be a security visit at&#xD;
      2 weeks to make sure that the IOPs remain within a safe range. Following S1 both study eyes&#xD;
      will receive laser treatment, as assigned by randomization, within a period of 2 weeks. Eyes&#xD;
      will be randomized to receive the SLT (SLT eye) or PLT (PLT eye) treatment. Both laser&#xD;
      procedures will be performed in one session (for 360° of the angle), if patients tolerate it.&#xD;
      Otherwise, they will be split into two sessions (each treating 180° of the angle) to be&#xD;
      performed within 1 week of each other. The same pre- and post-laser procedures will be&#xD;
      applied on both eyes.&#xD;
&#xD;
      After having signed and dated the patient informed consent form, patients will undergo an&#xD;
      initial ophthalmic examination. The CLS will be placed on both eyes for a baseline 24-hour&#xD;
      IOP pattern recording session (S1), within 2 weeks preceding the laser treatment. Patients&#xD;
      will remain ambulatory and will be encouraged to follow a schedule as close to his/her usual&#xD;
      lifestyle as possible. At hour 24, patients will return to the clinic, the device will be&#xD;
      removed and a final ophthalmic examination will be conducted. Patient diary will be collected&#xD;
      and concomitant medication will be reported.&#xD;
&#xD;
      Following S1 both study eyes will receive either SLT or PLT laser treatment, as assigned by&#xD;
      randomization (1:1), within a period of 2 weeks. The same pre- and post-laser procedures will&#xD;
      be applied on both eyes.&#xD;
&#xD;
      At S2 (1 month after laser treatment) patients will be randomized to 24-hour CLS recording on&#xD;
      either the SLT or on the PLT eye (1:1). The same ophthalmic examinations as during S1 will be&#xD;
      conducted and patient diary collected.&#xD;
&#xD;
      At month 3 patients will be followed up with a slit lamp examination and IOP measurement. At&#xD;
      months 6 and 12, patients will be seen for a complete ophthalmic examination including visual&#xD;
      field exam (Octopus, Switzerland), optic nerve and retinal nerve fiber layer evaluation&#xD;
      (Spectralis OCT, Germany). The overall study duration for the patient is limited to up to 14&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    departure of principal investigator from the organisation&#xD;
  </why_stopped>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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 in IOP from baseline to 1 month post-surgery as measured by tonometry</measure>
    <time_frame>1 month</time_frame>
    <description>Change in IOP from baseline to 1 month post-surgery as measured by tonometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>o Complete success: Reduction of at least 20% in IOP without medication</measure>
    <time_frame>1 month</time_frame>
    <description>Complete success: Reduction of at least 20% in IOP without medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>o Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication</measure>
    <time_frame>1 Month</time_frame>
    <description>Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication</description>
  </secondary_outcome>
  <other_outcome>
    <measure>• CLS derived parameters including: o Wake-to-Sleep slopes, as measured by the linear change in IOP from before going to bed to after</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>CLS derived parameters including:</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Glaucoma and Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Pattern laser trabeculoplasty (PLT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pattern laser trabeculoplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selective laser trabeculoplasty (SLT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selective laser trabeculoplasty (SLT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Selective laser trabeculoplasty (SLT)</intervention_name>
    <description>Selective laser trabeculoplasty</description>
    <arm_group_label>Selective laser trabeculoplasty (SLT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pattern laser trabeculoplasty (PLT)</intervention_name>
    <description>Pattern laser trabeculoplasty (PLT)</description>
    <arm_group_label>Pattern laser trabeculoplasty (PLT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary&#xD;
             glaucoma&#xD;
&#xD;
          -  Patients requiring bilateral laser trabeculoplasty for IOP control&#xD;
&#xD;
          -  Structural glaucomatous damage and/or documented glaucomatous VF damage (in the&#xD;
             previous 12 months with mean defect (MD) &gt; 2.5 dB&#xD;
&#xD;
          -  No or stable anti-glaucomatous drug therapy since at least 3 months. Able to undergo&#xD;
             medication washout for 4 weeks prior to baseline 24-h IOP monitoring session.&#xD;
&#xD;
          -  Aged ≥18 years, of either sex&#xD;
&#xD;
          -  Not more than 6 diopters spherical equivalent on the study eye&#xD;
&#xD;
          -  Have given written informed consent, prior to any investigational procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refractory glaucoma&#xD;
&#xD;
          -  Patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery&#xD;
             for the treatment of glaucoma.&#xD;
&#xD;
          -  Corneal or conjunctival abnormality precluding contact lens adaptation&#xD;
&#xD;
          -  Severe dry eye syndrome&#xD;
&#xD;
          -  Patients with allergy to corneal anesthetic&#xD;
&#xD;
          -  Patients with contraindications for silicone contact lens wear&#xD;
&#xD;
          -  Patients not able to understand the character and individual consequences of the&#xD;
             investigation&#xD;
&#xD;
          -  Participation in other clinical research within the last 4 weeks&#xD;
&#xD;
          -  Any other contra-indication listed in the CLS (SENSIMED Triggerfish) user manual&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaweh Mansouri</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ophtalmology department - Hôpitaux Universitaires de Genève</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève, Ophtalmology Department</name>
      <address>
        <city>Geneva</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Dr. Kaweh Mansouri</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Ocular Hypertension</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/NCT02231515
org study id: 1219
nct id: NCT02231515
lead sponsor: 
has dmc: No
A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of
      selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with open-angle
      glaucoma.
This is a prospective, randomised, controlled study. Patients will be selected for this study
      who require bilateral laser trabeculoplasty for IOP control. Eyes will undergo a medication
      wash-out 4 weeks prior to the baseline study session (S1). There will be a security visit at
      2 weeks to make sure that the IOPs remain within a safe range. Following S1 both study eyes
      will receive laser treatment, as assigned by randomization, within a period of 2 weeks. Eyes
      will be randomized to receive the SLT (SLT eye) or PLT (PLT eye) treatment. Both laser
      procedures will be performed in one session (for 360° of the angle), if patients tolerate it.
      Otherwise, they will be split into two sessions (each treating 180° of the angle) to be
      performed within 1 week of each other. The same pre- and post-laser procedures will be
      applied on both eyes.

      After having signed and dated the patient informed consent form, patients will undergo an
      initial ophthalmic examination. The CLS will be placed on both eyes for a baseline 24-hour
      IOP pattern recording session (S1), within 2 weeks preceding the laser treatment. Patients
      will remain ambulatory and will be encouraged to follow a schedule as close to his/her usual
      lifestyle as possible. At hour 24, patients will return to the clinic, the device will be
      removed and a final ophthalmic examination will be conducted. Patient diary will be collected
      and concomitant medication will be reported.

      Following S1 both study eyes will receive either SLT or PLT laser treatment, as assigned by
      randomization (1:1), within a period of 2 weeks. The same pre- and post-laser procedures will
      be applied on both eyes.

      At S2 (1 month after laser treatment) patients will be randomized to 24-hour CLS recording on
      either the SLT or on the PLT eye (1:1). The same ophthalmic examinations as during S1 will be
      conducted and patient diary collected.

      At month 3 patients will be followed up with a slit lamp examination and IOP measurement. At
      months 6 and 12, patients will be seen for a complete ophthalmic examination including visual
      field exam (Octopus, Switzerland), optic nerve and retinal nerve fiber layer evaluation
      (Spectralis OCT, Germany). The overall study duration for the patient is limited to up to 14
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: • Change in IOP from baseline to 1 month post-surgery as measured by tonometry
time frame: 1 month
description: Change in IOP from baseline to 1 month post-surgery as measured by tonometry
measure: o Complete success: Reduction of at least 20% in IOP without medication
time frame: 1 month
description: Complete success: Reduction of at least 20% in IOP without medication
measure: o Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication
time frame: 1 Month
description: Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication
measure: • CLS derived parameters including: o Wake-to-Sleep slopes, as measured by the linear change in IOP from before going to bed to after
time frame: 3 and 6 months
description: CLS derived parameters including:
arm group label: Pattern laser trabeculoplasty (PLT)
arm group type: Experimental
description: Pattern laser trabeculoplasty
arm group label: Selective laser trabeculoplasty (SLT)
arm group type: Active Comparator
description: Selective laser trabeculoplasty (SLT)
intervention type: Device
intervention name: Selective laser trabeculoplasty (SLT)
description: Selective laser trabeculoplasty
arm group label: Selective laser trabeculoplasty (SLT)
intervention type: Device
intervention name: Pattern laser trabeculoplasty (PLT)
description: Pattern laser trabeculoplasty (PLT)
arm group label: Pattern laser trabeculoplasty (PLT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kaweh Mansouri
role: Principal Investigator
affiliation: Ophtalmology department - Hôpitaux Universitaires de Genève
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Dr. Kaweh Mansouri
investigator title: MD
mesh term: Glaucoma
mesh term: Ocular Hypertension