<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/NCT03804216</url>
  </required_header>
  <id_info>
    <org_study_id>OCTADIAL</org_study_id>
    <nct_id>NCT03804216</nct_id>
  </id_info>
  <brief_title>Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients</brief_title>
  <acronym>OCTADIAL</acronym>
  <official_title>Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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>
      Little knowledge exist on the short and long-term ophthalmological effect of the dialysis.&#xD;
      Some studies stated a variation of the thickness subfoveal choroidal before and after a&#xD;
      session of dialyse as well as variations of the coat of optical fibers measured in OCT.&#xD;
&#xD;
      The Optical Coherence Tomography angiography OCT is a not invasive imaging technique which is&#xD;
      now a part of examinations of investigation in imaging of retina. This technique allows to&#xD;
      study the retinal macula vascularization without injection of contrast agent and thus allows&#xD;
      to deepen the knowledge in medical domains where the exploration was to limited because of&#xD;
      the invasive character of the examinations.&#xD;
&#xD;
      The hypothesis of this project is that hemodynamic change during the hemodialysis may lead&#xD;
      fine variations of the retinal vascularization in the short-term (the day of the dialysis)&#xD;
      but also in the longer term (over 1 year).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 26, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>vascular density before hemodialysis</measure>
    <time_frame>before hemodialysis</time_frame>
    <description>Analysis of the variation of the vascular densities in retinal macula in the central 6 mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>vascular density 1 hour after hemodialysis</measure>
    <time_frame>1 hour after hemodialysis</time_frame>
    <description>Analysis of the variation of the vascular densities in retinal macula in the central 6 mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>vascular density 1 month after dialysis</measure>
    <time_frame>1 month after dialysis</time_frame>
    <description>Analysis of the variation of the vascular densities in retinal macula in the central 6 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density 3 month after dialysis</measure>
    <time_frame>3 month after dialysis</time_frame>
    <description>Analysis of the variation of the vascular densities in retinal macula in the central 6 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density 6 month after dialysis</measure>
    <time_frame>6 month after dialysis</time_frame>
    <description>Analysis of the variation of the vascular densities in retinal macula in the central 6 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density 12 month after dialysis</measure>
    <time_frame>12 month after dialysis</time_frame>
    <description>Analysis of the variation of the vascular densities in retinal macula in the central 6 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density before dialysis</measure>
    <time_frame>before dialysis</time_frame>
    <description>mesure by OCTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density 1 hour after dialysis</measure>
    <time_frame>1 hour after dialysis</time_frame>
    <description>mesure by OCTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density 1 month after dialysis</measure>
    <time_frame>1 month after dialysis</time_frame>
    <description>mesure by OCTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density 3 month after dialysis</measure>
    <time_frame>3 month after dialysis</time_frame>
    <description>mesure by OCTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density 6 month after dialysis</measure>
    <time_frame>6 month after dialysis</time_frame>
    <description>mesure by OCTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular density 12 month after dialysis</measure>
    <time_frame>12 month after dialysis</time_frame>
    <description>mesure by OCTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>size of coat retinal optical fibers before dialysis</measure>
    <time_frame>before dialysis</time_frame>
    <description>variation of the coat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>size of coat retinal optical fibers 1 hour after dialysis</measure>
    <time_frame>1 hour after dialysis</time_frame>
    <description>variation of the coat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>size of coat retinal optical fibers 1 month after dialysis</measure>
    <time_frame>1 month after dialysis</time_frame>
    <description>variation of the coat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>size of coat retinal optical fibers 3 month after dialysis</measure>
    <time_frame>3 month after dialysis</time_frame>
    <description>variation of the coat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>size of coat retinal optical fibers 6 month after dialysis</measure>
    <time_frame>6 month after dialysis</time_frame>
    <description>variation of the coat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>size of coat retinal optical fibers 12 month after dialysis</measure>
    <time_frame>12 month after dialysis</time_frame>
    <description>variation of the coat</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Renal Failure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multimodal Imaging Analysis</intervention_name>
    <description>The patients are seen in consultation ophthalmological before and the 1 hour after their session of dialysis. THE OCT angiography and other not invasive ophthalmological examinations will be realized during the follow-up</description>
    <other_name>SD-OCT and OCT Angiography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients in hemodialysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication of treatment by hemodialysis&#xD;
&#xD;
          -  First session of dialysis&#xD;
&#xD;
          -  Hemodialysis planned for 1 minimum year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  particular ophthalmological Histories: vitreo-retinal surgery, strong nearsightedness,&#xD;
             chronic glaucoma&#xD;
&#xD;
          -  Unaffiliated in a national insurance scheme&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ophtalmology department</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</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>Renal Insufficiency</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/NCT03804216
org study id: OCTADIAL
nct id: NCT03804216
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Little knowledge exist on the short and long-term ophthalmological effect of the dialysis.
      Some studies stated a variation of the thickness subfoveal choroidal before and after a
      session of dialyse as well as variations of the coat of optical fibers measured in OCT.

      The Optical Coherence Tomography angiography OCT is a not invasive imaging technique which is
      now a part of examinations of investigation in imaging of retina. This technique allows to
      study the retinal macula vascularization without injection of contrast agent and thus allows
      to deepen the knowledge in medical domains where the exploration was to limited because of
      the invasive character of the examinations.

      The hypothesis of this project is that hemodynamic change during the hemodialysis may lead
      fine variations of the retinal vascularization in the short-term (the day of the dialysis)
      but also in the longer term (over 1 year).
observational model: Case-Only
time perspective: Prospective
measure: vascular density before hemodialysis
time frame: before hemodialysis
description: Analysis of the variation of the vascular densities in retinal macula in the central 6 mm
measure: vascular density 1 hour after hemodialysis
time frame: 1 hour after hemodialysis
description: Analysis of the variation of the vascular densities in retinal macula in the central 6 mm
measure: vascular density 1 month after dialysis
time frame: 1 month after dialysis
description: Analysis of the variation of the vascular densities in retinal macula in the central 6 mm
measure: vascular density 3 month after dialysis
time frame: 3 month after dialysis
description: Analysis of the variation of the vascular densities in retinal macula in the central 6 mm
measure: vascular density 6 month after dialysis
time frame: 6 month after dialysis
description: Analysis of the variation of the vascular densities in retinal macula in the central 6 mm
measure: vascular density 12 month after dialysis
time frame: 12 month after dialysis
description: Analysis of the variation of the vascular densities in retinal macula in the central 6 mm
measure: vascular density before dialysis
time frame: before dialysis
description: mesure by OCTA
measure: vascular density 1 hour after dialysis
time frame: 1 hour after dialysis
description: mesure by OCTA
measure: vascular density 1 month after dialysis
time frame: 1 month after dialysis
description: mesure by OCTA
measure: vascular density 3 month after dialysis
time frame: 3 month after dialysis
description: mesure by OCTA
measure: vascular density 6 month after dialysis
time frame: 6 month after dialysis
description: mesure by OCTA
measure: vascular density 12 month after dialysis
time frame: 12 month after dialysis
description: mesure by OCTA
measure: size of coat retinal optical fibers before dialysis
time frame: before dialysis
description: variation of the coat
measure: size of coat retinal optical fibers 1 hour after dialysis
time frame: 1 hour after dialysis
description: variation of the coat
measure: size of coat retinal optical fibers 1 month after dialysis
time frame: 1 month after dialysis
description: variation of the coat
measure: size of coat retinal optical fibers 3 month after dialysis
time frame: 3 month after dialysis
description: variation of the coat
measure: size of coat retinal optical fibers 6 month after dialysis
time frame: 6 month after dialysis
description: variation of the coat
measure: size of coat retinal optical fibers 12 month after dialysis
time frame: 12 month after dialysis
description: variation of the coat
intervention type: Other
intervention name: Multimodal Imaging Analysis
description: The patients are seen in consultation ophthalmological before and the 1 hour after their session of dialysis. THE OCT angiography and other not invasive ophthalmological examinations will be realized during the follow-up
other name: SD-OCT and OCT Angiography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Renal Insufficiency