<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/NCT01691183</url>
  </required_header>
  <id_info>
    <org_study_id>12-0705</org_study_id>
    <nct_id>NCT01691183</nct_id>
  </id_info>
  <brief_title>Reliability of Hertel Exophthalmometer Measurements</brief_title>
  <official_title>Reliability of Hertel Exophthalmometer Measurements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to learn about the variability in proptosis&#xD;
      measurements. Measurements will be recorded using the Hertel exophthalmometer. This&#xD;
      noninvasive tool is an instrument designed to measure the forward protrusion of the eye and&#xD;
      may be used normally during a general eye exam. This instrument provides a method of&#xD;
      evaluating and recording the progression and regression of the prominence of an eye caused by&#xD;
      disorders such as thyroid disease and tumors of the orbit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1. In order to determine intrauser reliability of the Hertel exophthalmometer, patients&#xD;
      will have 2 independent exams using the Hertel exophthalmometer on the same day performed by&#xD;
      each of the same researcher (either DAC or HLP) in a blinded fashion. For each patient, we&#xD;
      will independently measure the base value and the values for the right and left eye&#xD;
      proptosis, respectively, using the same Hertel exophthalmometer. A randomization process will&#xD;
      be employed to determine which researcher (either DAC or HLP) will take the first set of&#xD;
      measurements. The distance of the observer from the patient will be standardized for all&#xD;
      measurements. Patient research data will be de-identified and recorded for each patient and&#xD;
      subsequently analyzed for interobserver reliability.&#xD;
&#xD;
      Aim 2. In order to determine interuser reliability of the Hertel exophthalmometer, patients&#xD;
      will have a second independent exam on the same day by the second observer as determined for&#xD;
      Aim 1 above. For each patient, we will independently measure the base value and the values&#xD;
      for the right and left eye proptosis, respectively, using the same Hertel exophthalmometer.&#xD;
      The distance of the observer from the patient will be standardized for all measurements.&#xD;
&#xD;
      Patient research data will be de-identified and recorded for each patient and subsequently&#xD;
      analyzed for interobserver reliability.&#xD;
&#xD;
      Aim 3. Variability in Hertel measurements may be related in large part to differences in the&#xD;
      base measurement. The base measurement is determined by the bony orbital structures and&#xD;
      should not be significantly affected over time by the soft tissue remodeling commonly seen in&#xD;
      TED and most other orbital disease processes. We will have the second observer re-measure the&#xD;
      same patient using the same Hertel exophthalmometer by beginning with the same base&#xD;
      measurement determined by the first observer. Again, all measurement distances will be&#xD;
      standardized. No other information will be provided to the second observer other than the&#xD;
      beginning base measurement. Patient research data will again be de-identified prior to&#xD;
      recording the information and subsequently analyzed to determine if beginning with the same&#xD;
      base improves interobserver reliability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proptosis</measure>
    <time_frame>approximately 5 minutes</time_frame>
    <description>Amount of protrusion of eye from orbital rim measured in millimeters. Two people will be taking both a baseline and a secondary measurement to assess standardization of the &quot;base measurement&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>&quot;Base Measurement&quot;</measure>
    <time_frame>approximately 5 minutes</time_frame>
    <description>User #1 will take a baseline measurement and then a second measurement to help evaluate intrauser variability. User #2 will then independently take a baseline measurement (to help evaluate interuser variability) and then a second measurement after being provided only the base measurement of user #1's first measurement, in order to help determine if standardizing the base measurement will improve interuser variability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Orbital Disease status</measure>
    <time_frame>baseline</time_frame>
    <description>Record presence or absence of orbital disease at time of measurement</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">85</enrollment>
  <condition>Standardization of Hertel Measurements</condition>
  <arm_group>
    <arm_group_label>Study Subjects</arm_group_label>
    <description>Subjects with or without orbital disease that present to clinic for scheduled appointments.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        150 consecutive adult patients of both sexes and all ages will be recruited by David&#xD;
        Chesnutt MD from the UNC Eye Clinic. Patients taken from a pool of patients already&#xD;
        scheduled for appointments.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be at least 18 years old and will be able to converse in written and&#xD;
             spoken English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Chesnutt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Kittner Eye Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>June 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 21, 2012</last_update_submitted>
  <last_update_submitted_qc>September 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>David Chesnutt, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Hertel</keyword>
  <keyword>exophthalmometer</keyword>
  <keyword>proptosis</keyword>
  <keyword>eye disease</keyword>
  <!-- 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/NCT01691183
org study id: 12-0705
nct id: NCT01691183
lead sponsor: 
has dmc: No
The purpose of this research study is to learn about the variability in proptosis
      measurements. Measurements will be recorded using the Hertel exophthalmometer. This
      noninvasive tool is an instrument designed to measure the forward protrusion of the eye and
      may be used normally during a general eye exam. This instrument provides a method of
      evaluating and recording the progression and regression of the prominence of an eye caused by
      disorders such as thyroid disease and tumors of the orbit.
Aim 1. In order to determine intrauser reliability of the Hertel exophthalmometer, patients
      will have 2 independent exams using the Hertel exophthalmometer on the same day performed by
      each of the same researcher (either DAC or HLP) in a blinded fashion. For each patient, we
      will independently measure the base value and the values for the right and left eye
      proptosis, respectively, using the same Hertel exophthalmometer. A randomization process will
      be employed to determine which researcher (either DAC or HLP) will take the first set of
      measurements. The distance of the observer from the patient will be standardized for all
      measurements. Patient research data will be de-identified and recorded for each patient and
      subsequently analyzed for interobserver reliability.

      Aim 2. In order to determine interuser reliability of the Hertel exophthalmometer, patients
      will have a second independent exam on the same day by the second observer as determined for
      Aim 1 above. For each patient, we will independently measure the base value and the values
      for the right and left eye proptosis, respectively, using the same Hertel exophthalmometer.
      The distance of the observer from the patient will be standardized for all measurements.

      Patient research data will be de-identified and recorded for each patient and subsequently
      analyzed for interobserver reliability.

      Aim 3. Variability in Hertel measurements may be related in large part to differences in the
      base measurement. The base measurement is determined by the bony orbital structures and
      should not be significantly affected over time by the soft tissue remodeling commonly seen in
      TED and most other orbital disease processes. We will have the second observer re-measure the
      same patient using the same Hertel exophthalmometer by beginning with the same base
      measurement determined by the first observer. Again, all measurement distances will be
      standardized. No other information will be provided to the second observer other than the
      beginning base measurement. Patient research data will again be de-identified prior to
      recording the information and subsequently analyzed to determine if beginning with the same
      base improves interobserver reliability.
observational model: Cohort
time perspective: Prospective
measure: Proptosis
time frame: approximately 5 minutes
description: Amount of protrusion of eye from orbital rim measured in millimeters. Two people will be taking both a baseline and a secondary measurement to assess standardization of the "base measurement".
measure: "Base Measurement"
time frame: approximately 5 minutes
description: User #1 will take a baseline measurement and then a second measurement to help evaluate intrauser variability. User #2 will then independently take a baseline measurement (to help evaluate interuser variability) and then a second measurement after being provided only the base measurement of user #1's first measurement, in order to help determine if standardizing the base measurement will improve interuser variability.
measure: Orbital Disease status
time frame: baseline
description: Record presence or absence of orbital disease at time of measurement
arm group label: Study Subjects
description: Subjects with or without orbital disease that present to clinic for scheduled appointments.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Chesnutt, MD
role: Principal Investigator
affiliation: UNC Chapel Hill
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: David Chesnutt, MD
investigator title: Assistant Professor