<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/NCT02225119</url>
  </required_header>
  <id_info>
    <org_study_id>140171</org_study_id>
    <secondary_id>14-EI-0171</secondary_id>
    <nct_id>NCT02225119</nct_id>
  </id_info>
  <brief_title>The Focal Electro-Oculogram in Macular Disease</brief_title>
  <official_title>The Focal Electro-Oculogram in Macular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Maculopathies are eye conditions that affect the center of the retina. Retina health&#xD;
      depends on the RPE, a layer behind the retina. A new test may measure the health of the&#xD;
      central retina and RPE.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To use the focal electro-oculogram test to understand how the central retina and RPE are&#xD;
      affected in maculopathies.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  People at least 10 years old with a maculopathy.&#xD;
&#xD;
        -  Healthy volunteers.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with medical and eye history and an eye exam. Pictures&#xD;
           will be taken of the eyes.&#xD;
&#xD;
        -  Their eyes may be dilated.&#xD;
&#xD;
        -  They may have a field test. They will look into a lens and press a button when they see&#xD;
           a light. First, they may sit in the dark for 40 minutes.&#xD;
&#xD;
        -  Participants will have 1-7 visits over 18 months.&#xD;
&#xD;
        -  Their vision will be tested and eye pressure measured.&#xD;
&#xD;
        -  Their pupils will be dilated with eye drops and researchers may take pictures of the&#xD;
           retina and the inside of the eye, and measure the thickness of the retina.&#xD;
&#xD;
        -  Participants will have an electro-oculogram. They will look at a 2 LED lights and follow&#xD;
           them back and forth for 10 seconds once per minute. Participants will be in darkness for&#xD;
           15 minutes and in light for 20 minutes. One skin electrode will be placed on the nose&#xD;
           and one next to the eye.&#xD;
&#xD;
        -  Participants with maculopathy will also have:&#xD;
&#xD;
        -  Field test.&#xD;
&#xD;
        -  Electroretinogram. Participants will get numbing eye drops and special contact lenses. A&#xD;
           small metal electrode will be taped to the forehead. Participants will watch flashing&#xD;
           lights and try not to blink. First, they may sit in the dark for 40 minutes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVE:&#xD;
&#xD;
      The objective of this protocol is to investigate the local response of the retinal pigment&#xD;
      epithelium (RPE) across the posterior pole of the eye by recording the focal electrooculogram&#xD;
      (EOG) in participants with macular disease.&#xD;
&#xD;
      STUDY POPULATION:&#xD;
&#xD;
      Up to 50 healthy volunteers and 80 participants, age 10 or older, with macular disorders&#xD;
      affecting the retina/retinal pigment epithelium complex. Examples of such macular disorders&#xD;
      include Stargardt s disease and age-related macular degeneration (AMD).&#xD;
&#xD;
      DESIGN:&#xD;
&#xD;
      This single-center, observational, case-control study will be comprised of three related&#xD;
      aims. The first aim is focused on developing the focal EOG method which will require&#xD;
      parameter optimization. The second aim is focused on establishing the normal range and&#xD;
      variability of the focal EOG in normal volunteers. The third aim is to examine the focal EOG&#xD;
      in participants with macular disease.&#xD;
&#xD;
      OUTCOME MEASURES:&#xD;
&#xD;
      The primary outcome for this study is to develop a method for recording the focal EOG. The&#xD;
      secondary outcome will be to establish the normal range for the focal EOG and determine the&#xD;
      inter-session and intra-session variabilities of this test. Exploratory outcomes include: 1)&#xD;
      to examine the focal EOG in participants with macular diseases and 2) determine the&#xD;
      inter-session and intra-session variabilities of this test in participants with macular&#xD;
      diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2015</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 7, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>develop method for recording focal EOG</measure>
    <time_frame>up to 6 months</time_frame>
    <description>to develop a method for recording the focal EOG in response to a central light stimulus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test</measure>
    <time_frame>up to 18 months</time_frame>
    <description>establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Macular Degeneration</condition>
  <condition>Age-Related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Affected</arm_group_label>
    <description>Participants with macular disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unaffected</arm_group_label>
    <description>Healthy volunteers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 50 healthy volunteers and 80 participants, age 10 or older, with macular disease;&#xD;
        examples of such disorders include Stargardt s disease and age-related macular degeneration&#xD;
        (AMD). NIH employees meeting the eligibility criteria may participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. Participant must be 10 years of age or older.&#xD;
&#xD;
               2. Participant (or legal guardian) must understand and sign the protocol s informed&#xD;
                  consent document.&#xD;
&#xD;
               3. Participant must be able to cooperate with the testing required for this study.&#xD;
&#xD;
               4. For Participants with macular disease only:&#xD;
&#xD;
                    1. Participant must have macular disease, defined as evidence of loss of&#xD;
                       centrally mediated retinal dysfunction and/or degeneration as established by&#xD;
                       standard clinical methods including perimetry, ERG and imaging.&#xD;
&#xD;
                    2. Participant must have a measurable visual acuity.&#xD;
&#xD;
               5. For Healthy Volunteers only:&#xD;
&#xD;
                    1. Participant must have visual acuity of 20/20 or better in at least one eye.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        1) Participant with pre-retinal media opacities that would prevent focal light&#xD;
        presentation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brett G Jeffrey, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Eye Institute (NEI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2014-EI-0171.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>May 26, 2023</verification_date>
  <study_first_submitted>August 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Retinal Images</keyword>
  <keyword>Retinal Pigment Epithelium</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02225119
org study id: 140171
secondary id: 14-EI-0171
nct id: NCT02225119
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      - Maculopathies are eye conditions that affect the center of the retina. Retina health
      depends on the RPE, a layer behind the retina. A new test may measure the health of the
      central retina and RPE.

      Objective:

      - To use the focal electro-oculogram test to understand how the central retina and RPE are
      affected in maculopathies.

      Eligibility:

        -  People at least 10 years old with a maculopathy.

        -  Healthy volunteers.

      Design:

        -  Participants will be screened with medical and eye history and an eye exam. Pictures
           will be taken of the eyes.

        -  Their eyes may be dilated.

        -  They may have a field test. They will look into a lens and press a button when they see
           a light. First, they may sit in the dark for 40 minutes.

        -  Participants will have 1-7 visits over 18 months.

        -  Their vision will be tested and eye pressure measured.

        -  Their pupils will be dilated with eye drops and researchers may take pictures of the
           retina and the inside of the eye, and measure the thickness of the retina.

        -  Participants will have an electro-oculogram. They will look at a 2 LED lights and follow
           them back and forth for 10 seconds once per minute. Participants will be in darkness for
           15 minutes and in light for 20 minutes. One skin electrode will be placed on the nose
           and one next to the eye.

        -  Participants with maculopathy will also have:

        -  Field test.

        -  Electroretinogram. Participants will get numbing eye drops and special contact lenses. A
           small metal electrode will be taped to the forehead. Participants will watch flashing
           lights and try not to blink. First, they may sit in the dark for 40 minutes.
OBJECTIVE:

      The objective of this protocol is to investigate the local response of the retinal pigment
      epithelium (RPE) across the posterior pole of the eye by recording the focal electrooculogram
      (EOG) in participants with macular disease.

      STUDY POPULATION:

      Up to 50 healthy volunteers and 80 participants, age 10 or older, with macular disorders
      affecting the retina/retinal pigment epithelium complex. Examples of such macular disorders
      include Stargardt s disease and age-related macular degeneration (AMD).

      DESIGN:

      This single-center, observational, case-control study will be comprised of three related
      aims. The first aim is focused on developing the focal EOG method which will require
      parameter optimization. The second aim is focused on establishing the normal range and
      variability of the focal EOG in normal volunteers. The third aim is to examine the focal EOG
      in participants with macular disease.

      OUTCOME MEASURES:

      The primary outcome for this study is to develop a method for recording the focal EOG. The
      secondary outcome will be to establish the normal range for the focal EOG and determine the
      inter-session and intra-session variabilities of this test. Exploratory outcomes include: 1)
      to examine the focal EOG in participants with macular diseases and 2) determine the
      inter-session and intra-session variabilities of this test in participants with macular
      diseases.
observational model: Case-Control
time perspective: Prospective
measure: develop method for recording focal EOG
time frame: up to 6 months
description: to develop a method for recording the focal EOG in response to a central light stimulus
measure: establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test
time frame: up to 18 months
description: establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test
arm group label: Affected
description: Participants with macular disease
arm group label: Unaffected
description: Healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Brett G Jeffrey, Ph.D.
role: Principal Investigator
affiliation: National Eye Institute (NEI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2014-EI-0171.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Macular Degeneration
sharing ipd: No