<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/NCT03798223</url>
  </required_header>
  <id_info>
    <org_study_id>Optimal SLT</org_study_id>
    <secondary_id>254861</secondary_id>
    <nct_id>NCT03798223</nct_id>
  </id_info>
  <brief_title>Optimal Treatment Protocol for Selective Laser Trabeculoplasty</brief_title>
  <acronym>OSLT</acronym>
  <official_title>Optimal Treatment Protocol for Selective Laser Trabeculoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vastra Gotaland Region</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial to evaluate which treatment protocol in selective laser&#xD;
      trabeculoplasty that is most optimal in terms of efficacy and safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial in which individuals scheduled for SLT are randomized to one of&#xD;
      four treatment protocols, which represent the most common variants of the treatment in&#xD;
      clinical use.&#xD;
&#xD;
      Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level&#xD;
      either 0,1 millijoules (mJ) below the microbubble formation limit (&quot;low&quot; energy) or at a&#xD;
      level that gives microbubbles at 50-75% of laser effects (&quot;high&quot; energy). This gives four&#xD;
      treatment arms: 180/low, 180/high, 360/low and 360/high. Group allocation is masked for the&#xD;
      patient and is coded in the records.&#xD;
&#xD;
      The results for short and long term treatment effects are compared between the groups, as&#xD;
      well as the complication rate and postoperative discomfort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2025</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The treatment protocol is masked for the patient and for the nurses conducting measures of intraocular pressure during follow-up.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in intraocular pressure (IOP)</measure>
    <time_frame>Before SLT and thereafter regularly for 3 years</time_frame>
    <description>The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures.&#xD;
Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Achievement of 20% reduction in IOP</measure>
    <time_frame>For 3 years</time_frame>
    <description>See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival (no additional intervention)</measure>
    <time_frame>For 3 years</time_frame>
    <description>Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival (SLT allowed)</measure>
    <time_frame>For 3 years</time_frame>
    <description>See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment will not be judged as failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain perioperatively: on a scale</measure>
    <time_frame>Immediately after treatment</time_frame>
    <description>The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain postoperatively: on a scale</measure>
    <time_frame>During the first month</time_frame>
    <description>The patient will grade post-operative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol, also stating the duration of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Light sensitivity postoperatively</measure>
    <time_frame>During the first month</time_frame>
    <description>The patient will grade post-operative sensitivity to light on an arbitrary scale between 0 (no difference) and 4 (very intense sensitivity to light) on a written protocol, also stating the duration of light sensitivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impairment of vision postoperatively</measure>
    <time_frame>During the first month</time_frame>
    <description>The patient will grade post-operative impairment of vision on an arbitrary scale between 0 (no difference) and 4 (cannot see ones own hand) on a written protocol, also stating the duration of vision impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Redness postoperatively</measure>
    <time_frame>During the first month</time_frame>
    <description>The patient will grade post-operative redness of the eye on an arbitrary scale between 0 (no difference) and 4 (very intense redness) on a written protocol, also stating the duration of redness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flare (inflammation measurement of the anterior chamber)</measure>
    <time_frame>Pre-operatively and then one day, one week and one month post-operatively.</time_frame>
    <description>15 participants from each treatment arm (60 in total, randomized in a separate block after informed consent) will undergo measurement with a Laser Flare Meter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks).</time_frame>
    <description>The type and frequency of adverse events will be recorded and analyzed in each of the study arms.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <condition>Pseudoexfoliation Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>180/low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>180/high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>360/low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>360/high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SLT</intervention_name>
    <description>A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description).</description>
    <arm_group_label>180/high</arm_group_label>
    <arm_group_label>180/low</arm_group_label>
    <arm_group_label>360/high</arm_group_label>
    <arm_group_label>360/low</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular&#xD;
             hypertension.&#xD;
&#xD;
          -  intra-ocular pressure (IOP) at least 18 mmHg treatment day.&#xD;
&#xD;
          -  treatment is performed by an experienced laser surgeon.&#xD;
&#xD;
          -  SLT treatment and follow-up are expected to be possible to perform in an adequate way,&#xD;
             considering anatomical factors, age and the general health of the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  change of IOP-lowering medication during the last three months.&#xD;
&#xD;
          -  planned change of intra-ocular-pressure-lowering medication.&#xD;
&#xD;
          -  previous glaucoma surgery (other than SLT and ALT)&#xD;
&#xD;
          -  previous intra-ocular surgery during the last three months.&#xD;
&#xD;
          -  previous intra-ocular inflammatory disease during the last year.&#xD;
&#xD;
          -  planned intra-ocular surgery.&#xD;
&#xD;
          -  hyper-pigmented anterior chamber angle.&#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 Ayala, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vastra Gotaland Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tobias Dahlgren, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vastra Gotaland Region</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ogonkliniken, Sodra Alvsborgs Sjukhus</name>
      <address>
        <city>Boras</city>
        <state>Vastra Gotaland</state>
        <zip>50182</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogonkliniken, Sahlgrenska Universitetssjukhuset</name>
      <address>
        <city>Molndal</city>
        <state>Vastra Gotaland</state>
        <zip>43130</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogonkliniken, Skaraborgs Sjukhus</name>
      <address>
        <city>Skovde</city>
        <state>Vastra Gotaland</state>
        <zip>54142</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogonkliniken NU-sjukvarden</name>
      <address>
        <city>Uddevalla</city>
        <state>Vastra Gotaland</state>
        <zip>45153</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Selective Laser Trabeculoplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Ocular Hypertension</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Exfoliation Syndrome</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/NCT03798223
org study id: Optimal SLT
secondary id: 254861
nct id: NCT03798223
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized controlled trial to evaluate which treatment protocol in selective laser
      trabeculoplasty that is most optimal in terms of efficacy and safety.
A randomized controlled trial in which individuals scheduled for SLT are randomized to one of
      four treatment protocols, which represent the most common variants of the treatment in
      clinical use.

      Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level
      either 0,1 millijoules (mJ) below the microbubble formation limit ("low" energy) or at a
      level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four
      treatment arms: 180/low, 180/high, 360/low and 360/high. Group allocation is masked for the
      patient and is coded in the records.

      The results for short and long term treatment effects are compared between the groups, as
      well as the complication rate and postoperative discomfort.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The treatment protocol is masked for the patient and for the nurses conducting measures of intraocular pressure during follow-up.
measure: Change in intraocular pressure (IOP)
time frame: Before SLT and thereafter regularly for 3 years
description: The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures.
Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.
measure: Achievement of 20% reduction in IOP
time frame: For 3 years
description: See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.
measure: Survival (no additional intervention)
time frame: For 3 years
description: Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).
measure: Survival (SLT allowed)
time frame: For 3 years
description: See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment will not be judged as failure.
measure: Pain perioperatively: on a scale
time frame: Immediately after treatment
description: The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol.
measure: Pain postoperatively: on a scale
time frame: During the first month
description: The patient will grade post-operative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol, also stating the duration of pain.
measure: Light sensitivity postoperatively
time frame: During the first month
description: The patient will grade post-operative sensitivity to light on an arbitrary scale between 0 (no difference) and 4 (very intense sensitivity to light) on a written protocol, also stating the duration of light sensitivity.
measure: Impairment of vision postoperatively
time frame: During the first month
description: The patient will grade post-operative impairment of vision on an arbitrary scale between 0 (no difference) and 4 (cannot see ones own hand) on a written protocol, also stating the duration of vision impairment.
measure: Redness postoperatively
time frame: During the first month
description: The patient will grade post-operative redness of the eye on an arbitrary scale between 0 (no difference) and 4 (very intense redness) on a written protocol, also stating the duration of redness.
measure: Flare (inflammation measurement of the anterior chamber)
time frame: Pre-operatively and then one day, one week and one month post-operatively.
description: 15 participants from each treatment arm (60 in total, randomized in a separate block after informed consent) will undergo measurement with a Laser Flare Meter.
measure: Adverse events
time frame: 3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks).
description: The type and frequency of adverse events will be recorded and analyzed in each of the study arms.
arm group label: 180/low
arm group type: Experimental
description: SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.
arm group label: 180/high
arm group type: Experimental
description: SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.
arm group label: 360/low
arm group type: Experimental
description: SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.
arm group label: 360/high
arm group type: Experimental
description: SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.
intervention type: Procedure
intervention name: SLT
description: A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description).
arm group label: 180/high
arm group label: 180/low
arm group label: 360/high
arm group label: 360/low
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcelo Ayala, MD, PhD
role: Study Chair
affiliation: Vastra Gotaland Region
last name: Tobias Dahlgren, MD
role: Principal Investigator
affiliation: Vastra Gotaland Region
facility: 
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ocular Hypertension
mesh term: Glaucoma, Open-Angle
mesh term: Exfoliation Syndrome
sharing ipd: No