<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/NCT03267849</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00133667</org_study_id>
    <nct_id>NCT03267849</nct_id>
  </id_info>
  <brief_title>Lamina Cribrosa Depth Change With Change in Eye Pressure</brief_title>
  <official_title>Lamina Cribrosa Depth Change With Change in Eye Pressure</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>
      This is a study of the compliance of the lamina cribrosa with change in eye pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glaucoma patients and control subjects will have their internal eye structure (lamina&#xD;
      cribrosa) imaged by optical coherence tomography (OCT) standard images at two different eye&#xD;
      pressures. In some participants, the eye pressure will be changed by one of two&#xD;
      interventions, wearing goggles or having laser suturelysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in anterior lamina cribrosa depth</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>OCT position of lamina measured at 2 eye pressures. Data will be calculated as change in parameters of interest per mm Hg change in eye pressure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>persons drinking water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>all persons in the study will have images of the eye at baseline eye pressure, then the intervention will be to drink 2 bottles of water to increase eye pressure or decrease eye pressure, then will have images taken a second time</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>wearing swimming goggles or having laser suturelysis</intervention_name>
    <description>Two images will be compared in each subject at two different eye pressures with the higher pressure having been produced by the interventions</description>
    <arm_group_label>persons drinking water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  persons who consent to drink water and be imaged&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-consenting persons&#xD;
&#xD;
          -  those who cannot be imaged&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harry A Quigley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Harry A Quigley, MD</last_name>
    <phone>4109552777</phone>
    <email>hquigley@jhmi.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harry A Quigley, MD</last_name>
      <phone>410-955-2777</phone>
      <email>hquigley@jhmi.edu</email>
    </contact>
    <contact_backup>
      <last_name>Pat Tracey, AB</last_name>
      <phone>4109552769</phone>
      <email>ptracey@jhmi.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</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>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</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>Yes</sharing_ipd>
    <ipd_description>deidentified information (imaging data) will be shared after initial publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>after initial publication, indefinitely</ipd_time_frame>
    <ipd_access_criteria>no restrictions</ipd_access_criteria>
  </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/NCT03267849
org study id: IRB00133667
nct id: NCT03267849
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study of the compliance of the lamina cribrosa with change in eye pressure.
Glaucoma patients and control subjects will have their internal eye structure (lamina
      cribrosa) imaged by optical coherence tomography (OCT) standard images at two different eye
      pressures. In some participants, the eye pressure will be changed by one of two
      interventions, wearing goggles or having laser suturelysis
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in anterior lamina cribrosa depth
time frame: Up to 2 months
description: OCT position of lamina measured at 2 eye pressures. Data will be calculated as change in parameters of interest per mm Hg change in eye pressure
arm group label: persons drinking water
arm group type: Experimental
description: all persons in the study will have images of the eye at baseline eye pressure, then the intervention will be to drink 2 bottles of water to increase eye pressure or decrease eye pressure, then will have images taken a second time
intervention type: Other
intervention name: wearing swimming goggles or having laser suturelysis
description: Two images will be compared in each subject at two different eye pressures with the higher pressure having been produced by the interventions
arm group label: persons drinking water
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harry A Quigley, MD
role: Principal Investigator
affiliation: Professor
last name: Harry A Quigley, MD
phone: 4109552777
email: hquigley@jhmi.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma, Open-Angle
sharing ipd: Yes
ipd description: deidentified information (imaging data) will be shared after initial publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: after initial publication, indefinitely
ipd access criteria: no restrictions