<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/NCT04459949</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #2020-91</org_study_id>
    <nct_id>NCT04459949</nct_id>
  </id_info>
  <brief_title>Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling</brief_title>
  <official_title>Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wills Eye</source>
  <oversight_info>
    <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>
      The purpose of this study is to compare the performance and anatomic outcomes of the&#xD;
      Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular&#xD;
      surgery.&#xD;
&#xD;
      Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task&#xD;
      from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps&#xD;
      have a larger platform and micro-abrasions along the forcep surface to increase grasping&#xD;
      ability and potentially limit trauma to the retina surface compared to the Grieshaber&#xD;
      forceps. This project may also serve as an education tool for fellows learning the basics of&#xD;
      ILM peeling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 6, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical time</measure>
    <time_frame>During surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of peeling - surgeon</measure>
    <time_frame>During surgery</time_frame>
    <description>Use of standardized questionnaire to the surgeon.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of peeling - masked grader</measure>
    <time_frame>Through study completion, up to one year</time_frame>
    <description>Use of standardized questionnaire to the masked grader.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Epiretinal Membrane</condition>
  <condition>Macular Holes</condition>
  <arm_group>
    <arm_group_label>Sharkskin Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Grieshaber Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sharkskin</intervention_name>
    <description>Use of Sharkskin ILM forceps</description>
    <arm_group_label>Sharkskin Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Grieshaber</intervention_name>
    <description>Use of Grieshaber ILM forceps</description>
    <arm_group_label>Grieshaber Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Macular pathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior vitreoretinal surgery&#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>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wills Eye</investigator_affiliation>
    <investigator_full_name>MidAtlantic Retina</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Perforations</mesh_term>
    <mesh_term>Epiretinal Membrane</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/NCT04459949
org study id: IRB #2020-91
nct id: NCT04459949
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to compare the performance and anatomic outcomes of the
      Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular
      surgery.

      Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task
      from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps
      have a larger platform and micro-abrasions along the forcep surface to increase grasping
      ability and potentially limit trauma to the retina surface compared to the Grieshaber
      forceps. This project may also serve as an education tool for fellows learning the basics of
      ILM peeling.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Surgical time
time frame: During surgery
measure: Ease of peeling - surgeon
time frame: During surgery
description: Use of standardized questionnaire to the surgeon.
measure: Ease of peeling - masked grader
time frame: Through study completion, up to one year
description: Use of standardized questionnaire to the masked grader.
arm group label: Sharkskin Arm
arm group type: Active Comparator
arm group label: Grieshaber Arm
arm group type: Placebo Comparator
intervention type: Device
intervention name: Sharkskin
description: Use of Sharkskin ILM forceps
arm group label: Sharkskin Arm
intervention type: Device
intervention name: Grieshaber
description: Use of Grieshaber ILM forceps
arm group label: Grieshaber Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Wills Eye
investigator full name: MidAtlantic Retina
investigator title: Principal Investigator
mesh term: Retinal Perforations
mesh term: Epiretinal Membrane
sharing ipd: No