<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/NCT04448080</url>
  </required_header>
  <id_info>
    <org_study_id>TAP MP3</org_study_id>
    <nct_id>NCT04448080</nct_id>
  </id_info>
  <brief_title>Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment</brief_title>
  <acronym>TAPMP3</acronym>
  <official_title>Topical Anesthesia vs. Analgosedation and Pain in Micropulse Transscleral Glaucoma Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Topical Anesthesia will be compared to Analgosedation for pain control in Micropulse&#xD;
      Transscleral Laser Treatment for Glaucoma (MP-TLT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For a patient, the perspective of a surgical treatment can mean both, hope, and anxiety. In&#xD;
      particular the fear of pain during and after surgery can cause tremendous anxiety. In&#xD;
      addition, possible side effects of general anesthesia and sedation should be considered, in&#xD;
      particular, in patients with multiple comorbidities. The investigators want to help patients&#xD;
      to cope with their anxiety and, in addition, minimize risks of surgical procedures including&#xD;
      side effects of anesthesia. With this project, the investigators aim to investigate whether&#xD;
      topical anesthesia - often used in ophthalmologic surgical procedures - can sufficiently&#xD;
      control pain during and after a glaucoma laser procedure compared to intravenous&#xD;
      analgosedation. As primary objective, the effectiveness in pain control of analgosedation and&#xD;
      topical anesthesia in MP-TLT will be compared. As secondary objective, the effect of the&#xD;
      anesthetic protocol used on postoperative visual related quality of life will be&#xD;
      investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>
    <intervention_model_description>This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>non</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain at 1 hour postop</measure>
    <time_frame>1 hour postop</time_frame>
    <description>Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain at 6 hours postop</measure>
    <time_frame>6 hours postop</time_frame>
    <description>Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain at 1 day postop</measure>
    <time_frame>1 day postop</time_frame>
    <description>Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain at 1 week postop</measure>
    <time_frame>1 week postop</time_frame>
    <description>Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain at 1 month postop</measure>
    <time_frame>1 month postop</time_frame>
    <description>Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Goldman-applanation intraocular pressure</measure>
    <time_frame>at 1 month</time_frame>
    <description>The change in intraocular pressure (IOP, [mmHg]) at one month compared to baseline will be computed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of hypotensive medication</measure>
    <time_frame>at 1 month</time_frame>
    <description>The change in the number of hypotensive medication(i.e. medication which lower the intraocular pressure) at one month compared to baseline will be computed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in best corrected decimal Snellen visual acuity</measure>
    <time_frame>at 1 month</time_frame>
    <description>The change in best corrected decimal Snellen visual acuity at one month compared to baseline will be computed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual related quality of life</measure>
    <time_frame>at 1 month</time_frame>
    <description>change in visual related quality of life at 1 month compared to baseline will be assessed by means of National Eye Institute Visual Function Questionnaire. The National Eye Institute Visual Function Questionnaire nas a minimum value of 0 and a maximum value of 100, wheras 100 means no limitions to a normal visual related quality of life (i.e. higher values represent a better outcome).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>pupil diameter</measure>
    <time_frame>at 1 month</time_frame>
    <description>change in pupil diameter at 1 month compared to baseline will be assessed</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Topical Anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>topical tetracaine eye drops (3 times, given in 1 minute intervals) followed by topical Xylocaine 2% Gel (alcohol-free formulation), given in 1 minute intervals for a total of 5 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Analgosedation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Remifentanil 1mg i.v., and, Thiopental i.v., adapted to patients' weight, age, and hepatic and renal function; usually, a bolus of 150-250mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)</intervention_name>
    <description>Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma</description>
    <arm_group_label>Analgosedation</arm_group_label>
    <arm_group_label>Topical Anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of primary open angle glaucoma (POAG)&#xD;
&#xD;
          -  age ≥18 years of age&#xD;
&#xD;
          -  Visual acuity ≥0.6 Decimal-Snellen&#xD;
&#xD;
          -  IOP ≥21 mmHg&#xD;
&#xD;
          -  &lt;/=3 anti-glaucoma drug (AGD) classes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cystoid macula edema (CME) observed by optical coherence tomography (OCT)&#xD;
&#xD;
          -  Status post CME&#xD;
&#xD;
          -  Diagnosis of epiretinal fibroplasia&#xD;
&#xD;
          -  Status post other operations than uncomplicated cataract interventions&#xD;
&#xD;
          -  Status post cataract operation less than 3 months ago&#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>Marc Töteberg-Harms, MD, FEBO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Dpt. of Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>Micropulse Transscleral Treatment for Glaucoma</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT04448080
org study id: TAP MP3
nct id: NCT04448080
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Topical Anesthesia will be compared to Analgosedation for pain control in Micropulse
      Transscleral Laser Treatment for Glaucoma (MP-TLT).
For a patient, the perspective of a surgical treatment can mean both, hope, and anxiety. In
      particular the fear of pain during and after surgery can cause tremendous anxiety. In
      addition, possible side effects of general anesthesia and sedation should be considered, in
      particular, in patients with multiple comorbidities. The investigators want to help patients
      to cope with their anxiety and, in addition, minimize risks of surgical procedures including
      side effects of anesthesia. With this project, the investigators aim to investigate whether
      topical anesthesia - often used in ophthalmologic surgical procedures - can sufficiently
      control pain during and after a glaucoma laser procedure compared to intravenous
      analgosedation. As primary objective, the effectiveness in pain control of analgosedation and
      topical anesthesia in MP-TLT will be compared. As secondary objective, the effect of the
      anesthetic protocol used on postoperative visual related quality of life will be
      investigated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma
primary purpose: Treatment
masking: None (Open Label)
masking description: non
measure: Pain at 1 hour postop
time frame: 1 hour postop
description: Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)
measure: Pain at 6 hours postop
time frame: 6 hours postop
description: Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)
measure: Pain at 1 day postop
time frame: 1 day postop
description: Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)
measure: Pain at 1 week postop
time frame: 1 week postop
description: Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)
measure: Pain at 1 month postop
time frame: 1 month postop
description: Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.)
measure: Change in Goldman-applanation intraocular pressure
time frame: at 1 month
description: The change in intraocular pressure (IOP, [mmHg]) at one month compared to baseline will be computed.
measure: Change in number of hypotensive medication
time frame: at 1 month
description: The change in the number of hypotensive medication(i.e. medication which lower the intraocular pressure) at one month compared to baseline will be computed.
measure: Change in best corrected decimal Snellen visual acuity
time frame: at 1 month
description: The change in best corrected decimal Snellen visual acuity at one month compared to baseline will be computed.
measure: visual related quality of life
time frame: at 1 month
description: change in visual related quality of life at 1 month compared to baseline will be assessed by means of National Eye Institute Visual Function Questionnaire. The National Eye Institute Visual Function Questionnaire nas a minimum value of 0 and a maximum value of 100, wheras 100 means no limitions to a normal visual related quality of life (i.e. higher values represent a better outcome).
measure: pupil diameter
time frame: at 1 month
description: change in pupil diameter at 1 month compared to baseline will be assessed
arm group label: Topical Anesthesia
arm group type: Experimental
description: topical tetracaine eye drops (3 times, given in 1 minute intervals) followed by topical Xylocaine 2% Gel (alcohol-free formulation), given in 1 minute intervals for a total of 5 minutes
arm group label: Analgosedation
arm group type: Active Comparator
description: Remifentanil 1mg i.v., and, Thiopental i.v., adapted to patients' weight, age, and hepatic and renal function; usually, a bolus of 150-250mg
intervention type: Device
intervention name: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)
description: Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma
arm group label: Analgosedation
arm group label: Topical Anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Töteberg-Harms, MD, FEBO
role: Principal Investigator
affiliation: University Hospital Zurich, Dpt. of Ophthalmology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Glaucoma
sharing ipd: No