<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/NCT01709916</url>
  </required_header>
  <id_info>
    <org_study_id>CMC-11-0037-CTIL</org_study_id>
    <nct_id>NCT01709916</nct_id>
  </id_info>
  <brief_title>Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients</brief_title>
  <acronym>IOP</acronym>
  <official_title>Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carmel Medical Center</source>
  <brief_summary>
    <textblock>
      Glaucoma is one of the leading causes of blindness in the west. The disease caused by high&#xD;
      intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss&#xD;
      of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of&#xD;
      the therapy it is common to measure the intra ocular pressure at different times of the day.&#xD;
      Most ophthalmologists admit the patient for one day at which intra ocular pressure is&#xD;
      measured at different times. This method does not mimic the patient daily routine and may not&#xD;
      reflect the true diurnal fluctuations.&#xD;
&#xD;
      For this reason some ophthalmologists measure the intra ocular pressure at different times&#xD;
      and at different days. It is not known if both methods give similar diurnal curves.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A study physician will install anesthetic eye drops and will color the eye drops film with&#xD;
      fluorescein. Study physician will use tonometer to measure the intra ocular pressure in each&#xD;
      eye. This is a standard procedure done in any ophthalmological examination. Each patient will&#xD;
      undergo intraocular pressure examination at 8:00, 12:00 and 16:00.&#xD;
&#xD;
      In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day&#xD;
      measurements. The day after intra ocular pressure will be measured at 8:00, two days after at&#xD;
      12:00 and three days after at 16:00. One month later the patient will undergo another serious&#xD;
      of intra ocular pressure measurements.&#xD;
&#xD;
      In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day&#xD;
      measurements. The day after intra ocular pressure will be measured at 8:00, two days after at&#xD;
      12:00 and three days after at 16:00.&#xD;
&#xD;
      The relationship between the two diurnal curves will be analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>IOP at different times of the day at same day versus different times and different days</measure>
    <time_frame>5 weeks</time_frame>
    <description>measurements of intra ocular pressure at different times of the day at same day versus different times and different days.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Glaucoma patients</arm_group_label>
    <description>Glaucoma patients treated with eye drops to lower the IOP.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Glaucoma patients using eye drops to lower intra ocular pressure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Glaucoma patient.&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
          -  Able to read and understand Hebrew, able to sign informed consent in Hebrew.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ophthalmic laser treatment or surgery 3 months prior to enrollment.&#xD;
&#xD;
          -  Eye infection or inflammation.&#xD;
&#xD;
          -  Corneal pathology altering IOP measurement.&#xD;
&#xD;
          -  Patients not cooperating during IOP measurement.&#xD;
&#xD;
          -  non compliant patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Orna Geyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carmel Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>February 23, 2015</last_update_submitted>
  <last_update_submitted_qc>February 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carmel Medical Center</investigator_affiliation>
    <investigator_full_name>Orna Geyer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>intra ocular pressure</keyword>
  <keyword>diurnal fluctuations</keyword>
  <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/NCT01709916
org study id: CMC-11-0037-CTIL
nct id: NCT01709916
lead sponsor: 
Glaucoma is one of the leading causes of blindness in the west. The disease caused by high
      intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss
      of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of
      the therapy it is common to measure the intra ocular pressure at different times of the day.
      Most ophthalmologists admit the patient for one day at which intra ocular pressure is
      measured at different times. This method does not mimic the patient daily routine and may not
      reflect the true diurnal fluctuations.

      For this reason some ophthalmologists measure the intra ocular pressure at different times
      and at different days. It is not known if both methods give similar diurnal curves.
A study physician will install anesthetic eye drops and will color the eye drops film with
      fluorescein. Study physician will use tonometer to measure the intra ocular pressure in each
      eye. This is a standard procedure done in any ophthalmological examination. Each patient will
      undergo intraocular pressure examination at 8:00, 12:00 and 16:00.

      In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day
      measurements. The day after intra ocular pressure will be measured at 8:00, two days after at
      12:00 and three days after at 16:00. One month later the patient will undergo another serious
      of intra ocular pressure measurements.

      In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day
      measurements. The day after intra ocular pressure will be measured at 8:00, two days after at
      12:00 and three days after at 16:00.

      The relationship between the two diurnal curves will be analyzed.
observational model: Case-Only
time perspective: Prospective
measure: IOP at different times of the day at same day versus different times and different days
time frame: 5 weeks
description: measurements of intra ocular pressure at different times of the day at same day versus different times and different days.
arm group label: Glaucoma patients
description: Glaucoma patients treated with eye drops to lower the IOP.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Orna Geyer, MD
role: Principal Investigator
affiliation: Carmel Medical Center
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Carmel Medical Center
investigator full name: Orna Geyer
investigator title: Professor
mesh term: Glaucoma