<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/NCT03799575</url>
  </required_header>
  <id_info>
    <org_study_id>MD26339</org_study_id>
    <nct_id>NCT03799575</nct_id>
  </id_info>
  <brief_title>Internal Limiting Membrane and Macular Hole</brief_title>
  <official_title>Morphology of Internal Limiting Membrane Peeled on Macular Hole Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Santa Maria, Portugal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Santa Maria, Portugal</source>
  <oversight_info>
    <has_dmc>No</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>
      Observational study of Internal Limiting Membrane peeled in macular Hole surgery and studied&#xD;
      by Transmission electronic Microscopy (TEM) and Optical Coherence Tomography (OCT) findings&#xD;
      in closed holes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A non-randomized prospective study of eyes with MH willing to have surgery at the Department&#xD;
      of Ophthalmology of Santa Maria Hospital, Lisbon.&#xD;
&#xD;
      Surgeries are performed under local or general anesthesia, pars plana vitrectomy with&#xD;
      internal limiting membrane peeling, fluid gas exchange and face down position.&#xD;
&#xD;
      Two samples of discarded ILM peeled in Macular hole surgery is studied in Laboratory.&#xD;
&#xD;
      Laboratory Analysis Two samples of ILM per patient are harvested, one will be immediately&#xD;
      fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM)&#xD;
      analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes&#xD;
      at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.&#xD;
      Both samples from same patient will follow the protocol available at&#xD;
      dx.doi.org/10.17504/protocols.io.qjiduke.&#xD;
&#xD;
      Image acquisition Six electron-micrographs will be acquired for each fragment, using a&#xD;
      Hitachi H-7000 electron microscope equipped with a megaview III digital camera. Fields of&#xD;
      interest will be randomly selected, and acquisition of 15,000x magnification images.&#xD;
&#xD;
      Histology and immunohistochemistry ILM samples will be stained with anti-GFAP antibody&#xD;
      (anti-glial fibrillary acidic protein), to detect this protein in glial cells.&#xD;
&#xD;
      Results:&#xD;
&#xD;
      Only successful macular hole closure will be considered, BCVA will be compared before and&#xD;
      after surgery and related to OCT findings. ILM findings in TEM analysis will be compared with&#xD;
      and without enriched medium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">July 2, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fibrosis in vitreal sides of Internal Limiting Membranes</measure>
    <time_frame>12 months</time_frame>
    <description>Fibrilliary process between two vitreal sides of Internal Limiting Membranes in contact, after incubation in enriched medium</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>C11.768.740</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <description>Two samples of ILM per patient are harvested, group A will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <description>Group B sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Transmission Electron Microscopy analysis</intervention_name>
    <description>Morphology of two vitreal side of Internal Limiting Membrane in contact</description>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Internal Limiting membrane&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A non-randomized prospective study of eyes with MH willing to have surgery at the&#xD;
        Department of Ophthalmology of Santa Maria Hospital, Lisbon.&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          1. Full Thickness Macular Hole&#xD;
&#xD;
          2. Male or female aged 18 years or older&#xD;
&#xD;
          3. Visual symptoms due to IMH&#xD;
&#xD;
          4. Intraocular pressure inferior to 21 mmHG&#xD;
&#xD;
          5. Signed informed consent form&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All macular holes were staged based on recent OCT based classification and only full&#xD;
             thickness macular hole, grade 2 to 4 IMH are considered for study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excluding criteria are maculopathy other than IMH, surgeries of recurrence of IMH,&#xD;
             other retinal diseases, or an axial length greater than 26.0 mm. Mean follow-up will&#xD;
             be at least 12 months after surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mun Y Faria, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nuno P Ferreira, MD</last_name>
    <phone>+351918503467</phone>
    <email>ngcpferreira@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andreia L Pinto, MSC</last_name>
    <phone>+351969721099</phone>
    <email>andreia.lucia.pinto@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Santa Maria</name>
      <address>
        <city>Lisbon</city>
        <state>Lisboa</state>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mun Y Faria, MD</last_name>
      <phone>+351966026791</phone>
      <email>munfaria1@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Santa Maria, Portugal</investigator_affiliation>
    <investigator_full_name>Mun Yueh de Faria</investigator_full_name>
    <investigator_title>MD</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>
  <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/NCT03799575
org study id: MD26339
nct id: NCT03799575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study of Internal Limiting Membrane peeled in macular Hole surgery and studied
      by Transmission electronic Microscopy (TEM) and Optical Coherence Tomography (OCT) findings
      in closed holes.
A non-randomized prospective study of eyes with MH willing to have surgery at the Department
      of Ophthalmology of Santa Maria Hospital, Lisbon.

      Surgeries are performed under local or general anesthesia, pars plana vitrectomy with
      internal limiting membrane peeling, fluid gas exchange and face down position.

      Two samples of discarded ILM peeled in Macular hole surgery is studied in Laboratory.

      Laboratory Analysis Two samples of ILM per patient are harvested, one will be immediately
      fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM)
      analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes
      at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.
      Both samples from same patient will follow the protocol available at
      dx.doi.org/10.17504/protocols.io.qjiduke.

      Image acquisition Six electron-micrographs will be acquired for each fragment, using a
      Hitachi H-7000 electron microscope equipped with a megaview III digital camera. Fields of
      interest will be randomly selected, and acquisition of 15,000x magnification images.

      Histology and immunohistochemistry ILM samples will be stained with anti-GFAP antibody
      (anti-glial fibrillary acidic protein), to detect this protein in glial cells.

      Results:

      Only successful macular hole closure will be considered, BCVA will be compared before and
      after surgery and related to OCT findings. ILM findings in TEM analysis will be compared with
      and without enriched medium.
observational model: Cohort
time perspective: Prospective
measure: Fibrosis in vitreal sides of Internal Limiting Membranes
time frame: 12 months
description: Fibrilliary process between two vitreal sides of Internal Limiting Membranes in contact, after incubation in enriched medium
arm group label: A
description: Two samples of ILM per patient are harvested, group A will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.
arm group label: B
description: Group B sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.
intervention type: Behavioral
intervention name: Transmission Electron Microscopy analysis
description: Morphology of two vitreal side of Internal Limiting Membrane in contact
arm group label: A
arm group label: B
Internal Limiting membrane
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mun Y Faria, MD
role: Principal Investigator
affiliation: Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT
last name: Nuno P Ferreira, MD
phone: +351918503467
email: ngcpferreira@gmail.com
last name: Andreia L Pinto, MSC
phone: +351969721099
email: andreia.lucia.pinto@gmail.com
facility: 
status: Recruiting
contact: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Hospital de Santa Maria, Portugal
investigator full name: Mun Yueh de Faria
investigator title: MD
mesh term: Retinal Perforations
sharing ipd: No