<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/NCT03023800</url>
  </required_header>
  <id_info>
    <org_study_id>2013meky013(2)</org_study_id>
    <nct_id>NCT03023800</nct_id>
  </id_info>
  <brief_title>Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes</brief_title>
  <official_title>A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Macular schisis associated with macular detachment is a one of the complications of high&#xD;
      myopia. There is controversy in the primary treatment for this situation. This study will&#xD;
      compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting&#xD;
      membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal&#xD;
      detachment associated with macular schisis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, open label, single center study comparing the efficacy of macular muckle + gas&#xD;
      injection versus internal limiting membrane peeling + gas tamponade on macular schisis&#xD;
      associated with macular detachment in eyes with high myopia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">October 12, 2017</completion_date>
  <primary_completion_date type="Actual">January 30, 2017</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>Retinal re-attachment rate</measure>
    <time_frame>3 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative best corrected visual acuity</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative macular structure on optical coherance tomography</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Retinoschisis</condition>
  <condition>Macular Detachment</condition>
  <condition>High Myopia</condition>
  <arm_group>
    <arm_group_label>Buckle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Macular buckling and intraocular gas (C3F8) injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Macular buckling</intervention_name>
    <description>Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.</description>
    <arm_group_label>Buckle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vitrectomy</intervention_name>
    <description>Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia</description>
    <arm_group_label>Vitrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter&#xD;
&#xD;
          -  macular schisis&#xD;
&#xD;
          -  macular retinal detachment&#xD;
&#xD;
          -  evidence of posterior staphyloma on clinical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe macular scar&#xD;
&#xD;
          -  macular detachment which extended to the peripheral retina (i.e., extension beyond the&#xD;
             major vascular arcades in more than one quadrant)&#xD;
&#xD;
          -  prominent vitreomacular traction&#xD;
&#xD;
          -  a history of vitrectomy or macular buckle&#xD;
&#xD;
          -  intraocular active hemorrhage or inflammation&#xD;
&#xD;
          -  any media opacity which precluded imaging or clinical evaluation of the macula&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin Lu, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>October 12, 2017</last_update_submitted>
  <last_update_submitted_qc>October 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Lin Lu</investigator_full_name>
    <investigator_title>Director of Fundus Disease Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Retinoschisis</mesh_term>
    <mesh_term>Dissociative Disorders</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/NCT03023800
org study id: 2013meky013(2)
nct id: NCT03023800
lead sponsor: 
has dmc: No
Macular schisis associated with macular detachment is a one of the complications of high
      myopia. There is controversy in the primary treatment for this situation. This study will
      compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting
      membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal
      detachment associated with macular schisis.
A randomized, open label, single center study comparing the efficacy of macular muckle + gas
      injection versus internal limiting membrane peeling + gas tamponade on macular schisis
      associated with macular detachment in eyes with high myopia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Retinal re-attachment rate
time frame: 3 month
measure: Post-operative best corrected visual acuity
time frame: 12 month
measure: Post-operative macular structure on optical coherance tomography
time frame: 12 month
arm group label: Buckle
arm group type: Experimental
description: Macular buckling and intraocular gas (C3F8) injection.
arm group label: Vitrectomy
arm group type: Active Comparator
description: Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).
intervention type: Procedure
intervention name: Macular buckling
description: Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.
arm group label: Buckle
intervention type: Procedure
intervention name: Vitrectomy
description: Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia
arm group label: Vitrectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Lin Lu, MD，PhD
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Lin Lu
investigator title: Director of Fundus Disease Center
mesh term: Myopia
mesh term: Retinoschisis
mesh term: Dissociative Disorders
sharing ipd: No