<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/NCT02203929</url>
  </required_header>
  <id_info>
    <org_study_id>MH-Progression</org_study_id>
    <nct_id>NCT02203929</nct_id>
  </id_info>
  <brief_title>Preoperative Progression of Macular Holes</brief_title>
  <official_title>Preoperative Progression of Macular Holes Using Optical Coherence Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glostrup University Hospital, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knowledge of the natural history and progression of macular holes is mainly limited to the&#xD;
      studies from the pre-optical coherence tomography era. By observing macular holes&#xD;
      preoperatively we are able to determine the extent of the preoperative macular hole&#xD;
      progression.&#xD;
&#xD;
      At our institution macular holes are treated in an elective setting. The majority of macular&#xD;
      holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation&#xD;
      followed by vitrectomy.&#xD;
&#xD;
      We wish to observe the effect of time and cataract surgery on the progression of macular&#xD;
      holes prior to vitrectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Macular hole Progression</measure>
    <time_frame>3 months preoperative</time_frame>
    <description>Serial optical coherence tomography (OCT) measurements in the preoperative period. The size of macular hole is determined by measuring the macular hole minimal linear diameter (µm).&#xD;
Size and stage of macular hole is determined at primary evaluation at tertiary ophthalmic center. Initial scan is followed by pre-vitrectomy scan if patient is pseudophakic. Initial OCT scan is followed by pre- and postcataract as well as pre-vitrectomy OCT scan if patient is pseudophakic.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>Visual acuity in ETDRS letters measured 3 month postoperatively</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Macular Holes</condition>
  <arm_group>
    <arm_group_label>Phakic eyes</arm_group_label>
    <description>Phakic eyes will be monitored with 4 preoperative optical coherence tomography scans as these patients will undergo phacoemulsification and intraocular lens implantation prior to their macular hole surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pseudophakic eyes</arm_group_label>
    <description>Phakic eyes will be monitored with 2 preoperative optical coherence tomography scans as there is no surgical intervention prior to the macular hole treatment.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary Ophthalmic University Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic macular hole stage II-IV&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Duration of symptoms ≤ 24 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous vitreomacular surgery&#xD;
&#xD;
          -  Ocular trauma&#xD;
&#xD;
          -  Significant visual function affecting disease (proliferative diabetic retinopathy,&#xD;
             diabetic macular edema, exudative macular degeneration)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Morten la Cour, DMSc</last_name>
    <role>Study Director</role>
    <affiliation>Glostrup University Hospital, Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glostrup Hospital, University of Copenhagen</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>February 10, 2016</last_update_submitted>
  <last_update_submitted_qc>February 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Glostrup University Hospital, Copenhagen</investigator_affiliation>
    <investigator_full_name>Mark Alberti</investigator_full_name>
    <investigator_title>BSc.med.</investigator_title>
  </responsible_party>
  <keyword>Macular Holes</keyword>
  <keyword>Progression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Perforations</mesh_term>
    <mesh_term>Disease Progression</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/NCT02203929
org study id: MH-Progression
nct id: NCT02203929
lead sponsor: 
has dmc: No
Knowledge of the natural history and progression of macular holes is mainly limited to the
      studies from the pre-optical coherence tomography era. By observing macular holes
      preoperatively we are able to determine the extent of the preoperative macular hole
      progression.

      At our institution macular holes are treated in an elective setting. The majority of macular
      holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation
      followed by vitrectomy.

      We wish to observe the effect of time and cataract surgery on the progression of macular
      holes prior to vitrectomy.
observational model: Cohort
time perspective: Prospective
measure: Macular hole Progression
time frame: 3 months preoperative
description: Serial optical coherence tomography (OCT) measurements in the preoperative period. The size of macular hole is determined by measuring the macular hole minimal linear diameter (µm).
Size and stage of macular hole is determined at primary evaluation at tertiary ophthalmic center. Initial scan is followed by pre-vitrectomy scan if patient is pseudophakic. Initial OCT scan is followed by pre- and postcataract as well as pre-vitrectomy OCT scan if patient is pseudophakic.
measure: Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity
time frame: 3 months postoperative
description: Visual acuity in ETDRS letters measured 3 month postoperatively
arm group label: Phakic eyes
description: Phakic eyes will be monitored with 4 preoperative optical coherence tomography scans as these patients will undergo phacoemulsification and intraocular lens implantation prior to their macular hole surgery
arm group label: Pseudophakic eyes
description: Phakic eyes will be monitored with 2 preoperative optical coherence tomography scans as there is no surgical intervention prior to the macular hole treatment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 120 Years
healthy volunteers: No
last name: Morten la Cour, DMSc
role: Study Director
affiliation: Glostrup University Hospital, Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Glostrup University Hospital, Copenhagen
investigator full name: Mark Alberti
investigator title: BSc.med.
mesh term: Retinal Perforations
mesh term: Disease Progression