<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/NCT02972749</url>
  </required_header>
  <id_info>
    <org_study_id>0127-16-WOMC</org_study_id>
    <nct_id>NCT02972749</nct_id>
  </id_info>
  <brief_title>Modifiable Factors and Glaucoma - RCT</brief_title>
  <official_title>Modifiable Factors in the Management of Glaucoma - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</source>
  <brief_summary>
    <textblock>
      There is growing awareness that environmental factors, behaviors and diet are intimately&#xD;
      related to patient health and may play a role in the pathogenesis and progression of&#xD;
      glaucoma. Evidence from recent years has shown that some behaviors and environmental factors&#xD;
      can affect the intraocular pressure, the primary risk factor for glaucoma. This study aims to&#xD;
      investigate whether simple and common lifestyle inteventions such as sleeping with a head&#xD;
      elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake&#xD;
      could affect intraocular pressure and other outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>Following 1 month of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Illness perception questionnaire results</measure>
    <time_frame>Following 1 month of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Intraocular Pressure</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recommendations for lifestyle changes which have shown to reduce IOP. recommendations include: Moderate aerobic exercise, High fiber diet, sleeping with a head elevation and moderating caffeine intake. while continuing prescribed medical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention. patients are instructed to continue prescribed medical therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Recommendations for lifestyle changes which have shown to reduce IOP. recommendations include: Moderate aerobic exercise, High fiber diet, sleeping with a head elevation and moderating caffeine intake. while continuing prescribed medical therapy.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with glaucoma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to attend follow-up&#xD;
&#xD;
          -  Contraindication for treatment or follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asaf Achiron, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolfson Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The E.Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>December 31, 2017</last_update_submitted>
  <last_update_submitted_qc>December 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2018</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>Glaucoma</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/NCT02972749
org study id: 0127-16-WOMC
nct id: NCT02972749
lead sponsor: 
There is growing awareness that environmental factors, behaviors and diet are intimately
      related to patient health and may play a role in the pathogenesis and progression of
      glaucoma. Evidence from recent years has shown that some behaviors and environmental factors
      can affect the intraocular pressure, the primary risk factor for glaucoma. This study aims to
      investigate whether simple and common lifestyle inteventions such as sleeping with a head
      elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake
      could affect intraocular pressure and other outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: Intraocular pressure
time frame: Following 1 month of treatment
measure: Illness perception questionnaire results
time frame: Following 1 month of treatment
arm group label: Intervention
arm group type: Experimental
description: Recommendations for lifestyle changes which have shown to reduce IOP. recommendations include: Moderate aerobic exercise, High fiber diet, sleeping with a head elevation and moderating caffeine intake. while continuing prescribed medical therapy.
arm group label: Control
arm group type: No Intervention
description: No intervention. patients are instructed to continue prescribed medical therapy.
intervention type: Behavioral
intervention name: Intervention
description: Recommendations for lifestyle changes which have shown to reduce IOP. recommendations include: Moderate aerobic exercise, High fiber diet, sleeping with a head elevation and moderating caffeine intake. while continuing prescribed medical therapy.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Asaf Achiron, MD
role: Principal Investigator
affiliation: Wolfson Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Glaucoma