<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/NCT04450420</url>
  </required_header>
  <id_info>
    <org_study_id>TCCPASTE</org_study_id>
    <nct_id>NCT04450420</nct_id>
  </id_info>
  <brief_title>Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness</brief_title>
  <acronym>TCC-PASTE</acronym>
  <official_title>Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HelpMeSee Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HelpMeSee Inc.</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>
      TCC-PASTE is a randomised controlled trial comparing a simulation based training curriculum&#xD;
      with standard training for ophthalmology residents learning to perform tunnel construction in&#xD;
      manual small incision cataract surgery. After obtaining informed consent, participating&#xD;
      trainees will be randomly assigned to learn to perform tunnel construction either through the&#xD;
      simulation based curriculum or through the standard curriculum at their institute. Trainees&#xD;
      assigned to simulation will learn through studying an eBook, participating in training&#xD;
      sessions supported by repeated practice on a virtual reality simulator, and supervised&#xD;
      training in live surgery to facilitate transfer of skill acquired in simulation to the&#xD;
      operating room. To determine the effect of simulation based training, we will assess the&#xD;
      number of errors trainees perform in the initial part of their intraoperative learning curve.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 16, 2019</primary_completion_date>
  <phase>Phase 2</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Expert raters assessing outcomes by watching videos of surgery were masked to the identity of the participating surgeon, their institutional affiliation, and the sequence in which they performed procedures in the trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total surgical errors</measure>
    <time_frame>12 weeks</time_frame>
    <description>Incidence of pre-specified errors during tunnel construction through video-based assessment: uveal prolapse (UP), buttonhole incision (BI), premature entry (PE), Descemet's detachment (DD), laceration of upper wall (UL), laceration of lateral walls of tunnel (LL), corneal endothelial touch (ET), contact with iris, (IC) and contact with the lens (LC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major surgical errors</measure>
    <time_frame>12 weeks</time_frame>
    <description>Incidence of pre-specified errors during tunnel construction through video-based assessment: uveal prolapse (UP), buttonhole incision (BI), premature entry (PE), Descemet's detachment (DD), laceration of upper wall (UL), laceration of lateral walls of tunnel (LL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minor surgical errors</measure>
    <time_frame>12 weeks</time_frame>
    <description>Incidence of pre-specified errors during tunnel construction through video-based assessment: corneal endothelial touch (ET), contact with iris, (IC) and contact with the lens (LC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical product/outcome assessment: scleral groove</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical product/outcome assessment: tunnel dissection</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical product/outcome assessment: paracentesis</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical product/outcome assessment: viscoelastic injection/exchange</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical product/outcome assessment: keratome entry and extensions</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall technical skill for tunnel construction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical skill: scleral groove</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical skill: tunnel dissection</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical skill: paracentesis</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical skill: viscoelastic injection/exchange</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical skill: keratome entry and extensions</measure>
    <time_frame>12 weeks</time_frame>
    <description>Custom developed structured rating scale; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Task-specific technical skill: scleral tunnel</measure>
    <time_frame>12 weeks</time_frame>
    <description>ICO-OSCAR:SICS; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Task-specific technical skill: corneal entry</measure>
    <time_frame>12 weeks</time_frame>
    <description>ICO-OSCAR:SICS; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Task-specific technical skill: paracentesis &amp; viscoelastic exchange</measure>
    <time_frame>12 weeks</time_frame>
    <description>ICO-OSCAR:SICS; video-based assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global technical skill</measure>
    <time_frame>12 weeks</time_frame>
    <description>Global indices in ICO-OSCAR:SICS; video-based assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of any surgical error or self-reported intervention by supervising surgeon to prevent error</measure>
    <time_frame>12 weeks</time_frame>
    <description>Any physical intervention or assistance by supervising surgeon is counted as an additional error</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of major surgical error or self-reported intervention by supervising surgeon to prevent error</measure>
    <time_frame>12 weeks</time_frame>
    <description>Any physical intervention or assistance by supervising surgeon is counted as an additional error</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of minor surgical error or self-reported intervention by supervising surgeon to prevent error</measure>
    <time_frame>12 weeks</time_frame>
    <description>Any physical intervention or assistance by supervising surgeon is counted as an additional error</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of any physical intervention or assistance by supervising surgeon</measure>
    <time_frame>12 weeks</time_frame>
    <description>Each instance of physical intervention or assistance by supervising surgeon is counted as one event.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of complete intervention or assistance by supervising surgeon</measure>
    <time_frame>12 weeks</time_frame>
    <description>Each instance of ake-over by supervising surgeon for the specific activity or rest of task is counted as one event.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Simulation based curriculum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three phases:&#xD;
Self-study of an eBook - Participating trainees will be required to learn material pertaining to tunnel construction and general surgical principles during SICS from an eBook that has been developed by HelpMeSee.&#xD;
Instructor led teaching - didactic training, lab activities to gain familiarity with instruments, simulator based training through deliberate practice, and debriefing with instructor.&#xD;
Instructor supervised performance of surgery on patients in the operating room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Current standard curriculum for resident training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simulation based curriculum</intervention_name>
    <description>See arm/group description</description>
    <arm_group_label>Simulation based curriculum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard training</intervention_name>
    <description>See arm/group description</description>
    <arm_group_label>Standard training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in a training program at a partner institute;&#xD;
&#xD;
          -  No or minimal prior experience with MSICS (trainees within the first 2-3 months of&#xD;
             matriculation, or having performed fewer than 20 procedures as the main surgeon but no&#xD;
             more than 5 MSICS procedures within 6 months preceding participation in TCC-PASTE);&#xD;
&#xD;
          -  Provide informed consent to participate in the study;&#xD;
&#xD;
          -  Able to participate in routine patient care activities, as required by the partner&#xD;
             institute, without the need to take overnight call for the duration corresponding to&#xD;
             the simulation training phase.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Performed scleral tunnel construction as the main surgeon in 20 or more procedures;&#xD;
&#xD;
          -  Prior experience with the HelpMeSee simulator or participation in the HelpMeSee&#xD;
             simulation training curriculum.&#xD;
&#xD;
          -  Required to take overnight call for the duration corresponding to simulation training&#xD;
             phase.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HelpMeSee Inc.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cataract</keyword>
  <keyword>MSICS</keyword>
  <keyword>manual small incision cataract surgery</keyword>
  <keyword>surgical simulation</keyword>
  <keyword>simulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT04450420
org study id: TCCPASTE
nct id: NCT04450420
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
TCC-PASTE is a randomised controlled trial comparing a simulation based training curriculum
      with standard training for ophthalmology residents learning to perform tunnel construction in
      manual small incision cataract surgery. After obtaining informed consent, participating
      trainees will be randomly assigned to learn to perform tunnel construction either through the
      simulation based curriculum or through the standard curriculum at their institute. Trainees
      assigned to simulation will learn through studying an eBook, participating in training
      sessions supported by repeated practice on a virtual reality simulator, and supervised
      training in live surgery to facilitate transfer of skill acquired in simulation to the
      operating room. To determine the effect of simulation based training, we will assess the
      number of errors trainees perform in the initial part of their intraoperative learning curve.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Expert raters assessing outcomes by watching videos of surgery were masked to the identity of the participating surgeon, their institutional affiliation, and the sequence in which they performed procedures in the trial.
measure: Total surgical errors
time frame: 12 weeks
description: Incidence of pre-specified errors during tunnel construction through video-based assessment: uveal prolapse (UP), buttonhole incision (BI), premature entry (PE), Descemet's detachment (DD), laceration of upper wall (UL), laceration of lateral walls of tunnel (LL), corneal endothelial touch (ET), contact with iris, (IC) and contact with the lens (LC).
measure: Major surgical errors
time frame: 12 weeks
description: Incidence of pre-specified errors during tunnel construction through video-based assessment: uveal prolapse (UP), buttonhole incision (BI), premature entry (PE), Descemet's detachment (DD), laceration of upper wall (UL), laceration of lateral walls of tunnel (LL).
measure: Minor surgical errors
time frame: 12 weeks
description: Incidence of pre-specified errors during tunnel construction through video-based assessment: corneal endothelial touch (ET), contact with iris, (IC) and contact with the lens (LC).
measure: Surgical product/outcome assessment: scleral groove
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Surgical product/outcome assessment: tunnel dissection
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Surgical product/outcome assessment: paracentesis
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Surgical product/outcome assessment: viscoelastic injection/exchange
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Surgical product/outcome assessment: keratome entry and extensions
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Overall technical skill for tunnel construction
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Technical skill: scleral groove
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Technical skill: tunnel dissection
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Technical skill: paracentesis
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Technical skill: viscoelastic injection/exchange
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Technical skill: keratome entry and extensions
time frame: 12 weeks
description: Custom developed structured rating scale; video-based assessment
measure: Task-specific technical skill: scleral tunnel
time frame: 12 weeks
description: ICO-OSCAR:SICS; video-based assessment
measure: Task-specific technical skill: corneal entry
time frame: 12 weeks
description: ICO-OSCAR:SICS; video-based assessment
measure: Task-specific technical skill: paracentesis & viscoelastic exchange
time frame: 12 weeks
description: ICO-OSCAR:SICS; video-based assessment
measure: Global technical skill
time frame: 12 weeks
description: Global indices in ICO-OSCAR:SICS; video-based assessment
measure: Incidence of any surgical error or self-reported intervention by supervising surgeon to prevent error
time frame: 12 weeks
description: Any physical intervention or assistance by supervising surgeon is counted as an additional error
measure: Incidence of major surgical error or self-reported intervention by supervising surgeon to prevent error
time frame: 12 weeks
description: Any physical intervention or assistance by supervising surgeon is counted as an additional error
measure: Incidence of minor surgical error or self-reported intervention by supervising surgeon to prevent error
time frame: 12 weeks
description: Any physical intervention or assistance by supervising surgeon is counted as an additional error
measure: Incidence of any physical intervention or assistance by supervising surgeon
time frame: 12 weeks
description: Each instance of physical intervention or assistance by supervising surgeon is counted as one event.
measure: Incidence of complete intervention or assistance by supervising surgeon
time frame: 12 weeks
description: Each instance of ake-over by supervising surgeon for the specific activity or rest of task is counted as one event.
arm group label: Simulation based curriculum
arm group type: Experimental
description: Three phases:
Self-study of an eBook - Participating trainees will be required to learn material pertaining to tunnel construction and general surgical principles during SICS from an eBook that has been developed by HelpMeSee.
Instructor led teaching - didactic training, lab activities to gain familiarity with instruments, simulator based training through deliberate practice, and debriefing with instructor.
Instructor supervised performance of surgery on patients in the operating room.
arm group label: Standard training
arm group type: Active Comparator
description: Current standard curriculum for resident training.
intervention type: Other
intervention name: Simulation based curriculum
description: See arm/group description
arm group label: Simulation based curriculum
intervention type: Other
intervention name: Standard training
description: See arm/group description
arm group label: Standard training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No