<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/NCT03805763</url>
  </required_header>
  <id_info>
    <org_study_id>ZZD-Macular Hole</org_study_id>
    <nct_id>NCT03805763</nct_id>
  </id_info>
  <brief_title>Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity</brief_title>
  <official_title>Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observing and describing the surgical effects of different extents of internal limiting&#xD;
      membrane peeling combined with internal limiting membrane insertion for macular hole&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Condition of postoperative healing of macular holes</measure>
    <time_frame>1 year</time_frame>
    <description>postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline in best-corrected visual acuity (BCVA)</measure>
    <time_frame>1 year</time_frame>
    <description>Assessed using the ETDRS protocol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change from baseline in foveal avascular zone (FAZ) areas and diameter</measure>
    <time_frame>1 year</time_frame>
    <description>Assessed on AngioOCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels</measure>
    <time_frame>1 year</time_frame>
    <description>Assessed on AngioOCT</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Macular Holes</condition>
  <arm_group>
    <arm_group_label>Large extent of ILM Peeling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extent of ILM peeling is 4DD and the ILM flap is inserted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Small extent of ILM Peeling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extent of ILM peeling is 2DD and the ILM flap is inserted</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Large extent of ILM Peeling</intervention_name>
    <description>The extent of ILM peeling is 4DD</description>
    <arm_group_label>Large extent of ILM Peeling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Small extent of ILM Peeling</intervention_name>
    <description>The extent of ILM peeling is 2DD</description>
    <arm_group_label>Small extent of ILM Peeling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clear diagnosis of macular hole;&#xD;
&#xD;
          -  The minimum diameter of the macular hole is &gt;400 μm;&#xD;
&#xD;
          -  Without serious systemic disease that make patients can not be operated;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suffering from severe retinal diseases such as: diabetic retinopathy, age-related&#xD;
             macular degeneration, peripheral retinal detachment, PVR, etc.;&#xD;
&#xD;
          -  opacitas in the refractive medium can not perform Angio-OCT and visual acuity&#xD;
             examination;&#xD;
&#xD;
          -  eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and&#xD;
             chronic keratitis, acute dacryocystitis;&#xD;
&#xD;
          -  traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;&#xD;
&#xD;
          -  having a history of vitrectomy surgery;&#xD;
&#xD;
          -  glaucoma in stage of preclinical, severe stenosis or closure;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zongduan Zhang, M.D,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Eye Hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zongduan Zhang, M.D,PhD</last_name>
    <phone>+86 13587604949</phone>
    <email>zzduan@yeah.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qintuo Pan, M.D</last_name>
    <phone>-86 13958851073</phone>
    <email>panqintuo@qq.com</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Xiangtian Zhou</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Perforations</mesh_term>
  </condition_browse>
  <!-- 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/NCT03805763
org study id: ZZD-Macular Hole
nct id: NCT03805763
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Observing and describing the surgical effects of different extents of internal limiting
      membrane peeling combined with internal limiting membrane insertion for macular hole
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Condition of postoperative healing of macular holes
time frame: 1 year
description: postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
measure: Mean change from baseline in best-corrected visual acuity (BCVA)
time frame: 1 year
description: Assessed using the ETDRS protocol
measure: change from baseline in foveal avascular zone (FAZ) areas and diameter
time frame: 1 year
description: Assessed on AngioOCT
measure: change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
time frame: 1 year
description: Assessed on AngioOCT
arm group label: Large extent of ILM Peeling
arm group type: Experimental
description: Extent of ILM peeling is 4DD and the ILM flap is inserted
arm group label: Small extent of ILM Peeling
arm group type: Experimental
description: Extent of ILM peeling is 2DD and the ILM flap is inserted
intervention type: Procedure
intervention name: Large extent of ILM Peeling
description: The extent of ILM peeling is 4DD
arm group label: Large extent of ILM Peeling
intervention type: Procedure
intervention name: Small extent of ILM Peeling
description: The extent of ILM peeling is 2DD
arm group label: Small extent of ILM Peeling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zongduan Zhang, M.D,PhD
role: Principal Investigator
affiliation: The Eye Hospital of Wenzhou Medical University
last name: Zongduan Zhang, M.D,PhD
phone: +86 13587604949
email: zzduan@yeah.net
last name: Qintuo Pan, M.D
phone: -86 13958851073
email: panqintuo@qq.com
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Xiangtian Zhou
investigator title: Professor
mesh term: Retinal Perforations