<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/NCT01687829</url>
  </required_header>
  <id_info>
    <org_study_id>F20120913</org_study_id>
    <nct_id>NCT01687829</nct_id>
  </id_info>
  <brief_title>Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis</brief_title>
  <official_title>Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yifan Feng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <brief_summary>
    <textblock>
      Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by&#xD;
      vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and&#xD;
      visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has&#xD;
      become used widely as an adjunctive procedure during MH surgery because the removal of ILM is&#xD;
      thought to reduce the tangential traction on the macula, a major factor in the pathogenesis&#xD;
      of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not&#xD;
      yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of&#xD;
      the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published&#xD;
      literature comparing surgical results with and without ILM peeling and and performed a&#xD;
      meta-analysis to determine whether there is any benefit or detriment anatomically and/or&#xD;
      visually.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anatomic Success rate</measure>
    <time_frame>12 months</time_frame>
    <description>Anatomic success defined as a closed hole without a visible edge or a flat hole without a rim of subretinal fluid.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Success Rate</measure>
    <time_frame>12 month</time_frame>
    <description>Functional Success defined as an improvement of 2 or more Snellen BCVA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best-corrected visual acuity</measure>
    <time_frame>12 month</time_frame>
    <description>All Snellen BCVA were converted to logarithm of the minimum angle of resolution (logMAR) BCVA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>12 months</time_frame>
    <description>Such as elevated intraocular pressure,retinal tear,rhegmatogenous retinal detachment</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Macular Holes</condition>
  <arm_group>
    <arm_group_label>ILM-on group</arm_group_label>
    <description>patients were scheduled to undergo macular hole surgery without internal limiting membrane (ILM) peeling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ILM-off group</arm_group_label>
    <description>patients were scheduled to undergo macular hole surgery with internal limiting membrane (ILM) peeling</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients were scheduled to undergo macular hole surgery and randomized to with and without&#xD;
        internal limiting membrane (ILM) peeling&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible participants are those with idiopathic FTMH in stages 2-3, of less or equal&#xD;
             than 18 months duration (based on symptoms reported by the patient) and with a visual&#xD;
             acuity equal to or worse than 20/40 in the study eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with idiopathic FTMH stages 2-3 but longer than 18 months duration or with&#xD;
             other causes of decreased vision (e.g. corneal scarring, age-related macular&#xD;
             degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute&#xD;
             visual field defects are present) and&#xD;
&#xD;
          -  Those with FTMH related to high myopia (&gt; 6 dioptres) or trauma will be excluded from&#xD;
             the study.&#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>Yifan Feng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wenzhou Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yifan Feng, MD</last_name>
      <phone>+86-577-88068880</phone>
      <email>wzafengyifan@163.com</email>
    </contact>
    <investigator>
      <last_name>Yifan Feng, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>February 12, 2014</last_update_submitted>
  <last_update_submitted_qc>February 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Yifan Feng</investigator_full_name>
    <investigator_title>Eye Hospital, Wenzhou Medical College, China</investigator_title>
  </responsible_party>
  <keyword>Macular Holes</keyword>
  <keyword>Internal limiting membrane</keyword>
  <keyword>peeling</keyword>
  <keyword>Surgery</keyword>
  <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/NCT01687829
org study id: F20120913
nct id: NCT01687829
lead sponsor: 
collaborator: 
Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by
      vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and
      visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has
      become used widely as an adjunctive procedure during MH surgery because the removal of ILM is
      thought to reduce the tangential traction on the macula, a major factor in the pathogenesis
      of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not
      yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of
      the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published
      literature comparing surgical results with and without ILM peeling and and performed a
      meta-analysis to determine whether there is any benefit or detriment anatomically and/or
      visually.
observational model: Case-Control
time perspective: Retrospective
measure: Anatomic Success rate
time frame: 12 months
description: Anatomic success defined as a closed hole without a visible edge or a flat hole without a rim of subretinal fluid.
measure: Functional Success Rate
time frame: 12 month
description: Functional Success defined as an improvement of 2 or more Snellen BCVA.
measure: Best-corrected visual acuity
time frame: 12 month
description: All Snellen BCVA were converted to logarithm of the minimum angle of resolution (logMAR) BCVA
measure: Complications
time frame: 12 months
description: Such as elevated intraocular pressure,retinal tear,rhegmatogenous retinal detachment
arm group label: ILM-on group
description: patients were scheduled to undergo macular hole surgery without internal limiting membrane (ILM) peeling
arm group label: ILM-off group
description: patients were scheduled to undergo macular hole surgery with internal limiting membrane (ILM) peeling
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yifan Feng, MD
role: Principal Investigator
affiliation: Wenzhou Medical University
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Yifan Feng
investigator title: Eye Hospital, Wenzhou Medical College, China
mesh term: Retinal Perforations