<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/NCT01704989</url>
  </required_header>
  <id_info>
    <org_study_id>LIP-SLT-2012</org_study_id>
    <nct_id>NCT01704989</nct_id>
  </id_info>
  <brief_title>The Laser in Pseudoexfoliation (LIP) Study</brief_title>
  <acronym>LIP</acronym>
  <official_title>A Randomised Controlled Trial to Compare the Clinical Effectiveness of Selective Laser Trabeculoplasty (SLT) Versus Topical Therapy in the Treatment of Pseudoexfoliative Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marcelo Nicolela</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk&#xD;
      factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for&#xD;
      approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this&#xD;
      region an ideal setting for studying patients with this condition. Despite associated high&#xD;
      morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge for&#xD;
      the clinician. Topical medical therapy is less effective than for primary open angle glaucoma&#xD;
      and patients often require early surgical therapy, with associated risks. Selective laser&#xD;
      trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative glaucoma,&#xD;
      although the evidence for this is presently lacking. The aim of the current study is to&#xD;
      provide the first controlled-trial evidence for the effectiveness of SLT, compared to topical&#xD;
      therapy, in the management of pseudoexfoliative glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
      The primary aim of this study is to compare the effectiveness, in terms of intraocular&#xD;
      pressure (IOP) control, of SLT and topical medical therapy in the primary treatment of&#xD;
      patients with high IOP secondary to PXF. The secondary aims of the study are:&#xD;
&#xD;
        1. To examine the relationship between the degree of angle pigmentation and reduction of&#xD;
           IOP&#xD;
&#xD;
        2. To examine adverse effects from SLT treatment in patients with PXF&#xD;
&#xD;
        3. To compare IOP-lowering effects of SLT in patients with PXF to patients with POAG (in&#xD;
           the LiGHT study, see structure below).&#xD;
&#xD;
      Study Population: All new patients with PXF who are naïve to treatment (and willing to&#xD;
      participate) will be recruited after their first hospital consultation. Both eyes will be&#xD;
      treated but only one eye per patient included in the analysis (eye with the higher presenting&#xD;
      IOP).&#xD;
&#xD;
      Structure: The study design mirrors that of National Institute of Health (NIHR-) funded, the&#xD;
      laser in glaucoma and ocular hypertension trial (LiGHT) in the UK and is a collaborative&#xD;
      study between a Canadian Institute and Moorfields Eye Hospital in London. This is a&#xD;
      single-study randomised (unmasked) control trial of a proposed treatment intervention (SLT)&#xD;
      versus a standard treatment (topical therapy).&#xD;
&#xD;
      Summary of study design Patients will be randomised to one of 2 trial arms: 'laser-pathway'&#xD;
      or 'medicine- pathway'. Following initial treatment, SLT patients will be followed up 1-2&#xD;
      weeks after treatment to check IOP and for potential side effects. The interval of subsequent&#xD;
      follow-up visits (between 4 and 12 months) will be governed by the level of IOP in relation&#xD;
      to the target IOP and the severity of glaucoma. Visual field testing (SITA standard, 24-2&#xD;
      test pattern) and imaging with the Hedidelberg Retina Tomograph (HRT III) will be performed&#xD;
      at each visit. Target IOP will be set using the Canadian Glaucoma Society guidelines&#xD;
      depending on the severity of glaucoma and the level of IOP. At subsequent visits, treatment&#xD;
      will be escalated if the target IOP is not met or if there is evidence of progression.&#xD;
&#xD;
      Duration of study The study will last 3 years. One year will be allowed for recruitment of&#xD;
      all study participants, so that a minimum follow-up of 2 years will be available.&#xD;
&#xD;
      All patients will have a medical history, gonioscopy, central corneal thickness (CCT)&#xD;
      measurement, IOP measurement with Goldmann applanation tonometry and dilated fundoscopy at&#xD;
      the baseline visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 4</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of drops (and surgical interventions) needed to reach target IOP.</measure>
    <time_frame>Change in IOP at 6 months, 12 months and 2 years (from baseline).</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage success</measure>
    <time_frame>At 6 months, 12 months and 2 years</time_frame>
    <description>Proportion of patients in whom SLT (or mono medical therapy) alone achieved target IOP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of angle pigment grade with IOP reduction from SLT</measure>
    <time_frame>6 months, 12 months, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of percentage success and number of drops in current study with the equivalent results of patients with POAG in the LiGHT study</measure>
    <time_frame>1 year and 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of progressing patients in each study arm (SLT or medical therapy) in terms of visual field loss and HRT.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Laser pathway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm in which patients first randomised to receive SLT laser</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm in which patients first selected to receive drops (Prostagladin analogue as first-line)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SLT Laser</intervention_name>
    <description>At the first treatment, SLT treatment will be delivered to 360 degrees of trabecular meshwork. At the first escalation of treatment, the superior 180 degrees will be retreated. Twenty-five non-overlapping shots per quadrant will be used with a starting power of 0.8 mJ and increments of 0.1 mJ (titrated to avoid large bubbles) with standard other settings (400 nm spot size, 3 nanosecond duration) using a Latina single-mirror goniolens. The IOP will be checked 1 hour post treatment and five days of guttae acular tds will be administered to the treatment eye following treatment. After 2 treatments of SLT, the laser treated arm of the study will follow the same pathway as the medical treatment arm.</description>
    <arm_group_label>Laser pathway</arm_group_label>
    <other_name>Slective Laser Trabeculoplasty (primary treatment)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prostagladin</intervention_name>
    <description>Treatment will be initiated with latanoprost 0.005%. At the first IOP check (1-2 months), if the IOP has not reached target IOP, a second line agent will be added (β-Blocker unless contraindicated). If target IOP is still not reached, a third agent will be considered (topical carbonic anhydrase inhibitor). Treatment may be switched, instead, at the discretion of the clinician if the reduction of IOP with an agent is deemed to be no different than the pre-treatment IOP. Surgical therapy will be considered if target IOP is not met, or there is high IOP (&gt;35 mmHg) or advanced damage at presentation.</description>
    <arm_group_label>Topical therapy</arm_group_label>
    <other_name>B-Blocker</other_name>
    <other_name>Carbonic anydrase inhibitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of PXF material on the anterior chamber structures by slit lamp&#xD;
             biomicroscopy.&#xD;
&#xD;
          -  An open drainage angle with no irido-trabecular contact on non-indentation gonioscopy&#xD;
             in primary position trabecular meshwork visible over 360 degrees.&#xD;
&#xD;
          -  Ocular hypertension or glaucoma deemed to require treatment by the attending&#xD;
             clinician.&#xD;
&#xD;
          -  A decision to treat has been made by a Consultant Glaucoma Specialist.&#xD;
&#xD;
          -  Age over 18 years and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Advanced glaucoma as determined by EMGT criteria 1: visual field loss mean deviation&#xD;
             worse than -12 dB in the better or -15 dB in the worse eye.&#xD;
&#xD;
          -  Co-existing other secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis etc)&#xD;
             or angle closure glaucoma.&#xD;
&#xD;
          -  History of retinal ischaemia, macular oedema or diabetic retinopathy.&#xD;
&#xD;
          -  Age-related macular degeneration with neovascularisation or geographic atrophy and VA&#xD;
             worse than 6/36.&#xD;
&#xD;
          -  Any previous intra-ocular surgery, except uncomplicated phacoemulsification at least&#xD;
             one year before.* Medically unfit for completion of the trial.&#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>Marcelo T Nicoela, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital District Health Authority/Dalhousie University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marcelo T Nicolela, MD</last_name>
    <phone>902-473-3622</phone>
    <email>nicolela@dal.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eye Care Centre, VG Site, QEII</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Marcelo T Nicolela, MD</last_name>
      <phone>902-473-3622</phone>
      <email>nicolela@dal.ca</email>
    </contact>
    <investigator>
      <last_name>Marcelo T Nicolela, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lesya Shuba, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rizwan Malik, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul Rafuse, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Balwantray Chauhan, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Marcelo Nicolela</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Glaucoma, SLT</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/NCT01704989
org study id: LIP-SLT-2012
nct id: NCT01704989
lead sponsor: 
collaborator: 
has dmc: No
A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk
      factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for
      approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this
      region an ideal setting for studying patients with this condition. Despite associated high
      morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge for
      the clinician. Topical medical therapy is less effective than for primary open angle glaucoma
      and patients often require early surgical therapy, with associated risks. Selective laser
      trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative glaucoma,
      although the evidence for this is presently lacking. The aim of the current study is to
      provide the first controlled-trial evidence for the effectiveness of SLT, compared to topical
      therapy, in the management of pseudoexfoliative glaucoma.
Objectives:

      The primary aim of this study is to compare the effectiveness, in terms of intraocular
      pressure (IOP) control, of SLT and topical medical therapy in the primary treatment of
      patients with high IOP secondary to PXF. The secondary aims of the study are:

        1. To examine the relationship between the degree of angle pigmentation and reduction of
           IOP

        2. To examine adverse effects from SLT treatment in patients with PXF

        3. To compare IOP-lowering effects of SLT in patients with PXF to patients with POAG (in
           the LiGHT study, see structure below).

      Study Population: All new patients with PXF who are naïve to treatment (and willing to
      participate) will be recruited after their first hospital consultation. Both eyes will be
      treated but only one eye per patient included in the analysis (eye with the higher presenting
      IOP).

      Structure: The study design mirrors that of National Institute of Health (NIHR-) funded, the
      laser in glaucoma and ocular hypertension trial (LiGHT) in the UK and is a collaborative
      study between a Canadian Institute and Moorfields Eye Hospital in London. This is a
      single-study randomised (unmasked) control trial of a proposed treatment intervention (SLT)
      versus a standard treatment (topical therapy).

      Summary of study design Patients will be randomised to one of 2 trial arms: 'laser-pathway'
      or 'medicine- pathway'. Following initial treatment, SLT patients will be followed up 1-2
      weeks after treatment to check IOP and for potential side effects. The interval of subsequent
      follow-up visits (between 4 and 12 months) will be governed by the level of IOP in relation
      to the target IOP and the severity of glaucoma. Visual field testing (SITA standard, 24-2
      test pattern) and imaging with the Hedidelberg Retina Tomograph (HRT III) will be performed
      at each visit. Target IOP will be set using the Canadian Glaucoma Society guidelines
      depending on the severity of glaucoma and the level of IOP. At subsequent visits, treatment
      will be escalated if the target IOP is not met or if there is evidence of progression.

      Duration of study The study will last 3 years. One year will be allowed for recruitment of
      all study participants, so that a minimum follow-up of 2 years will be available.

      All patients will have a medical history, gonioscopy, central corneal thickness (CCT)
      measurement, IOP measurement with Goldmann applanation tonometry and dilated fundoscopy at
      the baseline visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of drops (and surgical interventions) needed to reach target IOP.
time frame: Change in IOP at 6 months, 12 months and 2 years (from baseline).
measure: Percentage success
time frame: At 6 months, 12 months and 2 years
description: Proportion of patients in whom SLT (or mono medical therapy) alone achieved target IOP.
measure: Correlation of angle pigment grade with IOP reduction from SLT
time frame: 6 months, 12 months, 2 years
measure: Comparison of percentage success and number of drops in current study with the equivalent results of patients with POAG in the LiGHT study
time frame: 1 year and 2 years
measure: Number of progressing patients in each study arm (SLT or medical therapy) in terms of visual field loss and HRT.
time frame: 2 years
arm group label: Laser pathway
arm group type: Active Comparator
description: Arm in which patients first randomised to receive SLT laser
arm group label: Topical therapy
arm group type: Active Comparator
description: Arm in which patients first selected to receive drops (Prostagladin analogue as first-line)
intervention type: Procedure
intervention name: SLT Laser
description: At the first treatment, SLT treatment will be delivered to 360 degrees of trabecular meshwork. At the first escalation of treatment, the superior 180 degrees will be retreated. Twenty-five non-overlapping shots per quadrant will be used with a starting power of 0.8 mJ and increments of 0.1 mJ (titrated to avoid large bubbles) with standard other settings (400 nm spot size, 3 nanosecond duration) using a Latina single-mirror goniolens. The IOP will be checked 1 hour post treatment and five days of guttae acular tds will be administered to the treatment eye following treatment. After 2 treatments of SLT, the laser treated arm of the study will follow the same pathway as the medical treatment arm.
arm group label: Laser pathway
other name: Slective Laser Trabeculoplasty (primary treatment)
intervention type: Drug
intervention name: Prostagladin
description: Treatment will be initiated with latanoprost 0.005%. At the first IOP check (1-2 months), if the IOP has not reached target IOP, a second line agent will be added (β-Blocker unless contraindicated). If target IOP is still not reached, a third agent will be considered (topical carbonic anhydrase inhibitor). Treatment may be switched, instead, at the discretion of the clinician if the reduction of IOP with an agent is deemed to be no different than the pre-treatment IOP. Surgical therapy will be considered if target IOP is not met, or there is high IOP (>35 mmHg) or advanced damage at presentation.
arm group label: Topical therapy
other name: B-Blocker
other name: Carbonic anydrase inhibitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcelo T Nicoela, MD
role: Principal Investigator
affiliation: Capital District Health Authority/Dalhousie University
last name: Marcelo T Nicolela, MD
phone: 902-473-3622
email: nicolela@dal.ca
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Marcelo Nicolela
investigator title: Associate Professor
mesh term: Glaucoma