<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/NCT01687465</url>
  </required_header>
  <id_info>
    <org_study_id>CIHR granted glaucoma RCT</org_study_id>
    <nct_id>NCT01687465</nct_id>
  </id_info>
  <brief_title>A Trial to Compare the Laser Treatment (SLT vs. ALT) in Glaucoma Patients</brief_title>
  <acronym>SLTRepeat</acronym>
  <official_title>A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lasers are important therapy in glaucoma. They are a pivotal point in treatment between&#xD;
      medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser&#xD;
      treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used:&#xD;
      argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT&#xD;
      including causing less damage to the tissue it affects. One of the potential patient centered&#xD;
      benefits of this laser is that it may be repeatable. It is even possible that the old laser&#xD;
      ALT may be useable after an SLT treatment. This study aims to uncover whether repeat laser is&#xD;
      possible after SLT and if so which laser is more effective (ALT vs SLT). The potential of&#xD;
      repeating laser therapies may delay surgical treatment and its complications. Also&#xD;
      understanding which laser to use will help eye doctors know how to treat their patients at&#xD;
      this point of the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>Phase 3</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular Pressure</measure>
    <time_frame>12 months post operatively</time_frame>
    <description>IOP difference between baseline and 12 month post-laser.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the IOP lowering effect between the groups at other postoperative visits</measure>
    <time_frame>12 months</time_frame>
    <description>IOP difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the visual acuity between the groups at all visits.</measure>
    <time_frame>12 months</time_frame>
    <description>VA difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the trabecular meshwork pigmentation between the groups at all visits.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare any adverse events between the two groups at all visits.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SLT repeatability of long term follow up in glaucoma patients</measure>
    <time_frame>36 months after initial enrollment of the primary study</time_frame>
    <description>The follow up time has been extended two more years. Patients will be followed up Q6 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Argon laser trabeculoplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Up to the year 2005, the vast majority of ophthalmologists used Argon laser trabeculoplasty (ALT) as the mode of laser therapy. ALT is effective but its most significant problem is that its effectiveness decreases with re-treatment since the tissue it targets (the trabecular meshwork) is changed by the laser rendering repeat treatments less effective.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>selective laser trabeculoplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post 2005, a newer mode of laser therapy, selective laser trabeculoplasty (SLT) has emerged as the standard of care laser. There are many potential advantages to SLT but to date these advantages are only theoretical. The most important potential clinical advantage of SLT is that it causes less damage to the tissue it targets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Argon laser trabeculoplasty</intervention_name>
    <description>With Argon laser trabeculoplasty (ALT), thermal energy is used directed towards the Trabecular Meshwork (the site of aqueous drainage from the eye),which causes focal scarring of trabecular meshwork, thus enable fluid drainage more effectively. However, this procedure may not be repeatable since it causes too much damage to the trabecular meshwork.</description>
    <arm_group_label>Argon laser trabeculoplasty</arm_group_label>
    <arm_group_label>selective laser trabeculoplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Selective laser trabeculoplasty</intervention_name>
    <description>Selective laser trabeculoplasty is a relatively newer technology that uses a Nd:YAG laser to target specific cells within the trabecular meshwork. SLT does not cause coagulative damage to the trabecular meshwork, and thus has the advantage of being repeatable.</description>
    <arm_group_label>Argon laser trabeculoplasty</arm_group_label>
    <arm_group_label>selective laser trabeculoplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over age of 18 yo.&#xD;
&#xD;
          -  OAG including pigmentary dispersion syndrome and pseudoexfoliation&#xD;
&#xD;
          -  OAG has been treated with 360 degrees of SLT&#xD;
&#xD;
          -  two sighted eyes,&#xD;
&#xD;
          -  willing to participate after being informed of and reading the patient information&#xD;
             material.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Narrow angle glaucoma&#xD;
&#xD;
          -  Previous glaucoma surgery&#xD;
&#xD;
          -  Eye surgery expected in the next 12 months&#xD;
&#xD;
          -  Severe corneal disease&#xD;
&#xD;
          -  On or anticipated steroid in 6 months&#xD;
&#xD;
          -  Pregnant or breast feeding&#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>William G Hodge, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Research Institute, Univ. of Western Ontario</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rockyview General Hospital, University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3E 7M8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Alexandra Hospital, University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Centre, Dalhousie University</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H2R1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaser University, St. Joseph's Healthcare Hamilton, CAHS Regional Eye Institute</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8G 5E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivey Eye Institute, St. Joseph's Hospital, Western University</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre, University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University, Dept. of Ophthalmology, Royal Victoria Hospital,</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>William Hodge</investigator_full_name>
    <investigator_title>Professor of Department of Ophthalmology, Western University</investigator_title>
  </responsible_party>
  <keyword>glaucoma</keyword>
  <keyword>laser</keyword>
  <keyword>SLT</keyword>
  <keyword>ALT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT01687465
org study id: CIHR granted glaucoma RCT
nct id: NCT01687465
lead sponsor: 
has dmc: Yes
Lasers are important therapy in glaucoma. They are a pivotal point in treatment between
      medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser
      treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used:
      argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT
      including causing less damage to the tissue it affects. One of the potential patient centered
      benefits of this laser is that it may be repeatable. It is even possible that the old laser
      ALT may be useable after an SLT treatment. This study aims to uncover whether repeat laser is
      possible after SLT and if so which laser is more effective (ALT vs SLT). The potential of
      repeating laser therapies may delay surgical treatment and its complications. Also
      understanding which laser to use will help eye doctors know how to treat their patients at
      this point of the disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Intraocular Pressure
time frame: 12 months post operatively
description: IOP difference between baseline and 12 month post-laser.
measure: To compare the IOP lowering effect between the groups at other postoperative visits
time frame: 12 months
description: IOP difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
measure: To compare the visual acuity between the groups at all visits.
time frame: 12 months
description: VA difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
measure: To compare the trabecular meshwork pigmentation between the groups at all visits.
time frame: 12 months
measure: To compare any adverse events between the two groups at all visits.
time frame: 12 months
measure: SLT repeatability of long term follow up in glaucoma patients
time frame: 36 months after initial enrollment of the primary study
description: The follow up time has been extended two more years. Patients will be followed up Q6 months.
arm group label: Argon laser trabeculoplasty
arm group type: Active Comparator
description: Up to the year 2005, the vast majority of ophthalmologists used Argon laser trabeculoplasty (ALT) as the mode of laser therapy. ALT is effective but its most significant problem is that its effectiveness decreases with re-treatment since the tissue it targets (the trabecular meshwork) is changed by the laser rendering repeat treatments less effective.
arm group label: selective laser trabeculoplasty
arm group type: Active Comparator
description: Post 2005, a newer mode of laser therapy, selective laser trabeculoplasty (SLT) has emerged as the standard of care laser. There are many potential advantages to SLT but to date these advantages are only theoretical. The most important potential clinical advantage of SLT is that it causes less damage to the tissue it targets.
intervention type: Procedure
intervention name: Argon laser trabeculoplasty
description: With Argon laser trabeculoplasty (ALT), thermal energy is used directed towards the Trabecular Meshwork (the site of aqueous drainage from the eye),which causes focal scarring of trabecular meshwork, thus enable fluid drainage more effectively. However, this procedure may not be repeatable since it causes too much damage to the trabecular meshwork.
arm group label: Argon laser trabeculoplasty
arm group label: selective laser trabeculoplasty
intervention type: Procedure
intervention name: Selective laser trabeculoplasty
description: Selective laser trabeculoplasty is a relatively newer technology that uses a Nd:YAG laser to target specific cells within the trabecular meshwork. SLT does not cause coagulative damage to the trabecular meshwork, and thus has the advantage of being repeatable.
arm group label: Argon laser trabeculoplasty
arm group label: selective laser trabeculoplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William G Hodge, MD, PhD
role: Principal Investigator
affiliation: Lawson Research Institute, Univ. of Western Ontario
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: William Hodge
investigator title: Professor of Department of Ophthalmology, Western University
mesh term: Glaucoma