<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/NCT03750201</url>
  </required_header>
  <id_info>
    <org_study_id>GLAUrious-2017-01</org_study_id>
    <nct_id>NCT03750201</nct_id>
  </id_info>
  <brief_title>A Study to Assess an Automated Laser Device for Direct Selective Laser Trabeculoplasty</brief_title>
  <acronym>GLAUrious</acronym>
  <official_title>Direct Selective Laser Trabeculoplasty (DSLT) In Open Angle Glaucoma (POAG): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BelkinVision</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universita degli Studi di Genova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen's University, Belfast</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Moorfields Eye Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>BelkinVision</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>
      Glaucoma is an eye disease that results in damage to the optic nerve that progresses over&#xD;
      time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused&#xD;
      by a build-up of fluid in the eye. Glaucoma can result in blindness if left untreated and as&#xD;
      such it is extremely important to diagnose and treat the condition.&#xD;
&#xD;
      Selective Laser Trabeculoplasty (SLT) is a laser treatment that facilitates the outflow of&#xD;
      fluid from inside the eye. This has the potential of reducing the intraocular pressure within&#xD;
      the eye (the main way in which this disease is treated since there is no cure) and may assist&#xD;
      in helping to control the progression of this disease.&#xD;
&#xD;
      SLT (standard treatment) is a technique routinely carried out by glaucoma specialists. It is&#xD;
      conducted using a special type of lens (goniolens) that gently sits on the front surface of&#xD;
      the eye. The procedure takes approximately 5 minutes in duration.&#xD;
&#xD;
      This new treatment, Direct Selective Laser Trabeculoplasty (DSLT) is performed directly,&#xD;
      without there being any need to use a goniolens which sits on the eye, and it is a shorter&#xD;
      and simpler technique to conduct when compared to the standard SLT technique.&#xD;
&#xD;
      The purpose of this study is to assess the hypothesis that the treatment by new automated&#xD;
      device for DSLT is not worse in comparison with the standard SLT and determine that it is&#xD;
      effective in reducing intraocular pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glaucoma can result in blindness if left untreated and as such it is extremely important to&#xD;
      diagnose and treat the condition.&#xD;
&#xD;
      Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing&#xD;
      eye drops. Unfortunately, there can be side effects associated with the use of these eye&#xD;
      drops and there are reports of non-compliance due to difficulties in inserting these drops,&#xD;
      all of which can impact on how effective this treatment regimen is.&#xD;
&#xD;
      The purpose of this study is to assess how well the new automated DSLT device for laser&#xD;
      treatment of glaucoma or ocular hypertension works in comparison with the standard SLT and&#xD;
      determine that it is as effective in reducing intraocular pressure.&#xD;
&#xD;
      DSLT or SLT will be performed in the study eye according to the randomization assignment.&#xD;
      Eligible patients who sign the informed consent will be enrolled at each of the study sites,&#xD;
      and undergo a washout (in the case of being medicated). After washout there will be a&#xD;
      baseline visit, where continued eligibility is confirmed. Following confirmation of continued&#xD;
      eligibility, 50% of patients being randomized to each treatment group. Randomization will be&#xD;
      to a pre-determined randomization list.&#xD;
&#xD;
      The un-masked investigator(s) will open the envelope corresponding to the subject ID and&#xD;
      administer the treatment as indicated by the randomization envelope. The masked&#xD;
      ophthalmologist(s), who will perform the follow up, will be masked as to the nature of the&#xD;
      treatment the patient underwent.&#xD;
&#xD;
      Only one eye per participant will be included in the study and they will be treated using&#xD;
      either DSLT or SLT as per the randomized treatment allocation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2018</start_date>
  <completion_date type="Actual">May 22, 2022</completion_date>
  <primary_completion_date type="Actual">April 15, 2022</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>Single (Outcomes Assessor)</masking>
    <masking_description>Intra-ocular pressure (IOP) measurements by masked investigator or masked technique (masked reading).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment</measure>
    <time_frame>6 months</time_frame>
    <description>The mean baseline IOP (washed out for medicated patients) will be compared to the mean (washed out for medicated patients) IOP after the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of medications as compare to screening visit</measure>
    <time_frame>6 months</time_frame>
    <description>Number of medications at 6 months as compared to screening/Visit 1 (before treatment) and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with at least 20% reduction in IOP from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of subjects with at least 20% reduction in IOP at 6 months compared to baseline without surgical intervention</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>12 months</time_frame>
    <description>Rates of Ocular Adverse events (AEs) in each treatment group at or prior to the 12 months visit</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Open Angle Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Direct Selective Trabeculoplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment by the investigational device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selective Trabeculoplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment by the comparator device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Direct Selective Trabeculoplasty</intervention_name>
    <description>Laser surgery by automated direct automated SLT device to lower intraocular pressure</description>
    <arm_group_label>Direct Selective Trabeculoplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Selective Trabeculoplasty</intervention_name>
    <description>Laser surgery by standard SLT device to lower intraocular pressure</description>
    <arm_group_label>Selective Trabeculoplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 40 years or older, with visual acuity &gt; 6/60 in both eyes&#xD;
&#xD;
          2. Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular&#xD;
             hypertension&#xD;
&#xD;
          3. IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications)&#xD;
&#xD;
          4. Gonioscopically visible scleral spur for 360 degrees without indentation&#xD;
&#xD;
          5. Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)&#xD;
&#xD;
          6. Willing and able to participate in the 12-month study, to comply with the study&#xD;
             procedures and to adhere to the follow-up schedule&#xD;
&#xD;
          7. Participant capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities,&#xD;
             etc.)&#xD;
&#xD;
          2. Angle Closure Glaucoma&#xD;
&#xD;
          3. Congenital or developmental glaucoma&#xD;
&#xD;
          4. Secondary glaucoma except exfoliative or pigmentary glaucoma&#xD;
&#xD;
          5. Presence of any Peripheral Anterior Synechiae (PAS) in the study eye&#xD;
&#xD;
          6. Inability to conduct a reliable visual field (defined as fixation losses, false&#xD;
             positives or false negatives greater than 33%)&#xD;
&#xD;
          7. Any of the following visual field findings using the Humphrey visual field analyzer&#xD;
             the SITA-standard 24-2 program:&#xD;
&#xD;
               1. A visual field MD of worse than -12dB&#xD;
&#xD;
               2. Greater than or equal to 75% of points depressed below the 5% level and greater&#xD;
                  than or equal to 50% of points depressed below the 1% level on the PD plot&#xD;
&#xD;
               3. At least 50% of points (i.e 2 or more) within the central 5 degrees with a&#xD;
                  sensitivity ≤0dB on the decibel plot&#xD;
&#xD;
               4. Points within the central 5 degrees of fixation with a sensitivity &lt;15 dB in both&#xD;
                  hemifields on the decibel plot&#xD;
&#xD;
          8. A visual field MD of worse than -12dB in the fellow eye&#xD;
&#xD;
          9. Cup:Disc Ratio of more than 0.8&#xD;
&#xD;
         10. More than three hypotensive mediations required&#xD;
&#xD;
         11. Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye&#xD;
&#xD;
         12. Prior corneal refractive surgery&#xD;
&#xD;
         13. Complicated cataract surgery ≤ 6 months prior to enrollment&#xD;
&#xD;
         14. Presence of visually significant cataract in the opinion of the investigator&#xD;
&#xD;
         15. Clinically significant disease in either eye as determined by the Investigator&#xD;
&#xD;
         16. Clinically significant amblyopia in either eye&#xD;
&#xD;
         17. Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera&#xD;
&#xD;
         18. Women who are pregnant or may become pregnant during the study&#xD;
&#xD;
         19. In the opinion of the investigator the participant might require other ocular surgery&#xD;
             within the 12-month follow-up period, unless for further reduction of their IOP&#xD;
&#xD;
         20. Concurrent treatment with topical, nasal, inhaled or systemic steroids&#xD;
&#xD;
         21. Uncontrolled systemic disease that could impact the ability of the participant to&#xD;
             attend follow up visits as per the discretion of the investigator&#xD;
&#xD;
         22. Participation in another clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Congdon, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queens University Belfast</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soroka Medical Center</name>
      <address>
        <city>Be'er Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah-Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi di Genova</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens University Belfast</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moorfields Eye Hospital</name>
      <address>
        <city>London</city>
        <zip>EC1V 2PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Ocular Hypertension</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/NCT03750201
org study id: GLAUrious-2017-01
nct id: NCT03750201
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Glaucoma is an eye disease that results in damage to the optic nerve that progresses over
      time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused
      by a build-up of fluid in the eye. Glaucoma can result in blindness if left untreated and as
      such it is extremely important to diagnose and treat the condition.

      Selective Laser Trabeculoplasty (SLT) is a laser treatment that facilitates the outflow of
      fluid from inside the eye. This has the potential of reducing the intraocular pressure within
      the eye (the main way in which this disease is treated since there is no cure) and may assist
      in helping to control the progression of this disease.

      SLT (standard treatment) is a technique routinely carried out by glaucoma specialists. It is
      conducted using a special type of lens (goniolens) that gently sits on the front surface of
      the eye. The procedure takes approximately 5 minutes in duration.

      This new treatment, Direct Selective Laser Trabeculoplasty (DSLT) is performed directly,
      without there being any need to use a goniolens which sits on the eye, and it is a shorter
      and simpler technique to conduct when compared to the standard SLT technique.

      The purpose of this study is to assess the hypothesis that the treatment by new automated
      device for DSLT is not worse in comparison with the standard SLT and determine that it is
      effective in reducing intraocular pressure.
Glaucoma can result in blindness if left untreated and as such it is extremely important to
      diagnose and treat the condition.

      Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing
      eye drops. Unfortunately, there can be side effects associated with the use of these eye
      drops and there are reports of non-compliance due to difficulties in inserting these drops,
      all of which can impact on how effective this treatment regimen is.

      The purpose of this study is to assess how well the new automated DSLT device for laser
      treatment of glaucoma or ocular hypertension works in comparison with the standard SLT and
      determine that it is as effective in reducing intraocular pressure.

      DSLT or SLT will be performed in the study eye according to the randomization assignment.
      Eligible patients who sign the informed consent will be enrolled at each of the study sites,
      and undergo a washout (in the case of being medicated). After washout there will be a
      baseline visit, where continued eligibility is confirmed. Following confirmation of continued
      eligibility, 50% of patients being randomized to each treatment group. Randomization will be
      to a pre-determined randomization list.

      The un-masked investigator(s) will open the envelope corresponding to the subject ID and
      administer the treatment as indicated by the randomization envelope. The masked
      ophthalmologist(s), who will perform the follow up, will be masked as to the nature of the
      treatment the patient underwent.

      Only one eye per participant will be included in the study and they will be treated using
      either DSLT or SLT as per the randomized treatment allocation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Intra-ocular pressure (IOP) measurements by masked investigator or masked technique (masked reading).
measure: The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment
time frame: 6 months
description: The mean baseline IOP (washed out for medicated patients) will be compared to the mean (washed out for medicated patients) IOP after the treatment
measure: Number of medications as compare to screening visit
time frame: 6 months
description: Number of medications at 6 months as compared to screening/Visit 1 (before treatment) and compared between groups.
measure: Proportion of subjects with at least 20% reduction in IOP from baseline
time frame: 6 months
description: Proportion of subjects with at least 20% reduction in IOP at 6 months compared to baseline without surgical intervention
measure: Incidence of adverse events
time frame: 12 months
description: Rates of Ocular Adverse events (AEs) in each treatment group at or prior to the 12 months visit
arm group label: Direct Selective Trabeculoplasty
arm group type: Experimental
description: Treatment by the investigational device.
arm group label: Selective Trabeculoplasty
arm group type: Active Comparator
description: Treatment by the comparator device.
intervention type: Device
intervention name: Direct Selective Trabeculoplasty
description: Laser surgery by automated direct automated SLT device to lower intraocular pressure
arm group label: Direct Selective Trabeculoplasty
intervention type: Device
intervention name: Selective Trabeculoplasty
description: Laser surgery by standard SLT device to lower intraocular pressure
arm group label: Selective Trabeculoplasty
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan Congdon, MD, MPH
role: Principal Investigator
affiliation: Queens University Belfast
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Israel
country: Italy
country: United Kingdom
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
sharing ipd: No