<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/NCT03267862</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00090957</org_study_id>
    <nct_id>NCT03267862</nct_id>
  </id_info>
  <brief_title>Scleral Response to Intraocular Pressure (IOP)</brief_title>
  <official_title>Scleral Response to Intraocular Pressure (IOP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>
      The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were glaucoma patients who during routine care were observed at different eye&#xD;
      pressures. Images taken with an optical device that is routinely used in such patients were&#xD;
      analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2014</start_date>
  <completion_date type="Actual">August 29, 2017</completion_date>
  <primary_completion_date type="Actual">August 29, 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anterior lamina cribrosa depth change</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Position of anterior lamina observed by optical coherence tomography (OCT) imaging. Measured in micrometers (um).</description>
  </primary_outcome>
  <enrollment type="Actual">27</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>there was no intervention</intervention_name>
    <description>patients were observed during routine care on separate times when their eye pressure was different on one day from another.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        glaucoma patients presenting for routine care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  glaucoma patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-glaucoma patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>deidentified study data could be shared at this time</ipd_description>
  </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/NCT03267862
org study id: NA_00090957
nct id: NCT03267862
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.
Participants were glaucoma patients who during routine care were observed at different eye
      pressures. Images taken with an optical device that is routinely used in such patients were
      analysed.
observational model: Cohort
time perspective: Cross-Sectional
measure: Anterior lamina cribrosa depth change
time frame: Up to 2 months
description: Position of anterior lamina observed by optical coherence tomography (OCT) imaging. Measured in micrometers (um).
intervention type: Other
intervention name: there was no intervention
description: patients were observed during routine care on separate times when their eye pressure was different on one day from another.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Glaucoma, Open-Angle
sharing ipd: Undecided
ipd description: deidentified study data could be shared at this time