<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/NCT03287102</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A02061-52</org_study_id>
    <nct_id>NCT03287102</nct_id>
  </id_info>
  <brief_title>Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)</brief_title>
  <acronym>MARTIAL</acronym>
  <official_title>Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially&#xD;
      involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas&#xD;
      tamponade followed by facedown positioning. The initial 58% success rate has further&#xD;
      increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM&#xD;
      removal has been shown to lead to anatomic changes causing the retina to have the appearance&#xD;
      of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with&#xD;
      decreased retinal sensitivity that may cause visual discomfort despite good visual acuity.&#xD;
      Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM&#xD;
      flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory&#xD;
      surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and&#xD;
      retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM&#xD;
      flap technique and eyes that had complete 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">February 1, 2018</start_date>
  <completion_date type="Anticipated">February 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of dimples on optical coherence tomography</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Incidence of DONFL appearance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retinal sensitivity on microperimetry testing (decibel)</measure>
    <time_frame>3 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macular hole closure rate on optical coherence tomography</measure>
    <time_frame>3 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual acuity (Logarithm of the Minimum Angle of Resolution)</measure>
    <time_frame>3 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ellipsoide zone defect on optical coherence tomography</measure>
    <time_frame>3 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>External limiting membrane defect on optical coherence tomography</measure>
    <time_frame>3 months after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Macula Hole</condition>
  <arm_group>
    <arm_group_label>Temporal inverted ILM peeling group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The internal limiting membrane is peeled from the temporal side of the fovea only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Complete ILM peeling group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The internal limiting membrane is completely removed around the fovea</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Macular hole surgery</intervention_name>
    <description>Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade</description>
    <arm_group_label>Complete ILM peeling group</arm_group_label>
    <arm_group_label>Temporal inverted ILM peeling group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underage patients&#xD;
&#xD;
          -  History of intraocular surgery (except for cataract surgery)&#xD;
&#xD;
          -  Macular hole secondary to trauma, diabetic retinopathy, uveitis or associated with&#xD;
             retinal detachment&#xD;
&#xD;
          -  Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)&#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>
  <overall_official>
    <last_name>Jean-Baptiste CONART</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brabois Hospital, Nancy, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Baptiste CONART</last_name>
    <phone>+33383155203</phone>
    <email>jbconart@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brabois Hospital</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Jean-Baptiste CONART</last_name>
      <phone>+33383155203</phone>
      <email>jbconart@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Adelman RA, Nawrocki J. TEMPORAL INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE VERSUS CLASSIC INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE: A Comparative Study. Retina. 2015 Sep;35(9):1844-50. doi: 10.1097/IAE.0000000000000555.</citation>
    <PMID>25946691</PMID>
  </reference>
  <reference>
    <citation>Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Nawrocki J. Inverted internal limiting membrane flap technique for surgical repair of myopic macular holes. Retina. 2014 Apr;34(4):664-9. doi: 10.1097/IAE.0000000000000042.</citation>
    <PMID>24263468</PMID>
  </reference>
  <reference>
    <citation>Tadayoni R, Svorenova I, Erginay A, Gaudric A, Massin P. Decreased retinal sensitivity after internal limiting membrane peeling for macular hole surgery. Br J Ophthalmol. 2012 Dec;96(12):1513-6. doi: 10.1136/bjophthalmol-2012-302035. Epub 2012 Oct 17.</citation>
    <PMID>23077227</PMID>
  </reference>
  <reference>
    <citation>Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.</citation>
    <PMID>20541263</PMID>
  </reference>
  <reference>
    <citation>Tadayoni R, Paques M, Massin P, Mouki-Benani S, Mikol J, Gaudric A. Dissociated optic nerve fiber layer appearance of the fundus after idiopathic epiretinal membrane removal. Ophthalmology. 2001 Dec;108(12):2279-83. doi: 10.1016/s0161-6420(01)00856-9.</citation>
    <PMID>11733271</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Perforations</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/NCT03287102
org study id: 2017-A02061-52
nct id: NCT03287102
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially
      involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas
      tamponade followed by facedown positioning. The initial 58% success rate has further
      increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM
      removal has been shown to lead to anatomic changes causing the retina to have the appearance
      of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with
      decreased retinal sensitivity that may cause visual discomfort despite good visual acuity.
      Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM
      flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory
      surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and
      retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM
      flap technique and eyes that had complete ILM peeling
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of dimples on optical coherence tomography
time frame: 3 months after surgery
description: Incidence of DONFL appearance
measure: Retinal sensitivity on microperimetry testing (decibel)
time frame: 3 months after surgery
measure: Macular hole closure rate on optical coherence tomography
time frame: 3 months after surgery
measure: Visual acuity (Logarithm of the Minimum Angle of Resolution)
time frame: 3 months after surgery
measure: Ellipsoide zone defect on optical coherence tomography
time frame: 3 months after surgery
measure: External limiting membrane defect on optical coherence tomography
time frame: 3 months after surgery
arm group label: Temporal inverted ILM peeling group
arm group type: Other
description: The internal limiting membrane is peeled from the temporal side of the fovea only
arm group label: Complete ILM peeling group
arm group type: Other
description: The internal limiting membrane is completely removed around the fovea
intervention type: Procedure
intervention name: Macular hole surgery
description: Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade
arm group label: Complete ILM peeling group
arm group label: Temporal inverted ILM peeling group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Baptiste CONART
role: Principal Investigator
affiliation: Brabois Hospital, Nancy, France
last name: Jean-Baptiste CONART
phone: +33383155203
email: jbconart@hotmail.com
facility: 
contact: 
country: France
citation: Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Adelman RA, Nawrocki J. TEMPORAL INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE VERSUS CLASSIC INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE: A Comparative Study. Retina. 2015 Sep;35(9):1844-50. doi: 10.1097/IAE.0000000000000555.
PMID: 25946691
citation: Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Nawrocki J. Inverted internal limiting membrane flap technique for surgical repair of myopic macular holes. Retina. 2014 Apr;34(4):664-9. doi: 10.1097/IAE.0000000000000042.
PMID: 24263468
citation: Tadayoni R, Svorenova I, Erginay A, Gaudric A, Massin P. Decreased retinal sensitivity after internal limiting membrane peeling for macular hole surgery. Br J Ophthalmol. 2012 Dec;96(12):1513-6. doi: 10.1136/bjophthalmol-2012-302035. Epub 2012 Oct 17.
PMID: 23077227
citation: Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.
PMID: 20541263
citation: Tadayoni R, Paques M, Massin P, Mouki-Benani S, Mikol J, Gaudric A. Dissociated optic nerve fiber layer appearance of the fundus after idiopathic epiretinal membrane removal. Ophthalmology. 2001 Dec;108(12):2279-83. doi: 10.1016/s0161-6420(01)00856-9.
PMID: 11733271
responsible party type: Sponsor
mesh term: Retinal Perforations
sharing ipd: No