<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/NCT03286426</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00083580</org_study_id>
    <nct_id>NCT03286426</nct_id>
  </id_info>
  <brief_title>Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure</brief_title>
  <acronym>ICP</acronym>
  <official_title>Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the vision and posterior segment of eyes in children&#xD;
      and young adults less than 22 years of age with risk, suspicion, or past medical history&#xD;
      significant for elevated intracranial pressure (ICP). Patients will have visual acuity and&#xD;
      color vision tested. Assessment of the posterior segment will involve using a non-invasive&#xD;
      (non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital&#xD;
      settings).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The need for non-invasive evaluation of ICP is an active area of study. The current gold&#xD;
      standard is intraventricular or intraparenchymal catheters but these are invasive, expensive,&#xD;
      and require sedation; and thus the need for an effective non-invasive screening tool. The&#xD;
      utility of funduscopy in identifying processes affecting ICP has long been recognized, i.e.&#xD;
      papilledema, ocular venous engorgement, blurring of the optic disk. Studies have demonstrated&#xD;
      that funduscopy may have a role in the qualitative assessment of increased ICP as a highly&#xD;
      sensitive test. However, conventional bedside funduscopy does not allow for image capture and&#xD;
      may necessitate pupillary dilation. Portable fundus cameras address these issues, allowing&#xD;
      image capture and storage and the potential for non-mydriatic imaging, i.e. imaging without&#xD;
      dilation of eyes. And as demonstrated in a recent study, portable fundus cameras are&#xD;
      efficient (median exam time was 3 minutes and 24 seconds in a pediatric Emergency&#xD;
      Department).&#xD;
&#xD;
      Additionally, ICP screening in asymptomatic patients remains limited. Patients being treated&#xD;
      with medications for acne, specifically tetracyclines (e.g. minocycline and doxycycline),&#xD;
      retinol, and isotretinol, are at particular risk for increased ICP but often are not&#xD;
      identified until they are symptomatic (i.e. headaches, visual loss, papilledema). Symptom&#xD;
      onset has been documented from 2 weeks up to 1 year from drug initiation. The percentage of&#xD;
      patients with subclinical asymptomatic disease is unclear. This study would allow us to&#xD;
      describe the presence of subclinical disease in our population and the role/utility of&#xD;
      routine non-invasive screening methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID&#xD;
  </why_stopped>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">December 8, 2018</completion_date>
  <primary_completion_date type="Actual">December 8, 2018</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>
    <intervention_model_description>All patients will have images taken of the back of the eye with a portable fundus camera. If able, visual acuity and color vision will be checked.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Posterior Segment as Measured by Fundus Camera</measure>
    <time_frame>Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Visual Acuity</measure>
    <time_frame>Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)</measure>
    <time_frame>Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Intracranial Pressure Increase</condition>
  <arm_group>
    <arm_group_label>Vision/Eye Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Image of back of each eye along with color vision and visual acuity assessment if able.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pictor</intervention_name>
    <description>The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.</description>
    <arm_group_label>Vision/Eye Screening</arm_group_label>
    <other_name>portable fundus camera</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable and willing to provide consent&#xD;
&#xD;
          -  Less than 22 years of age&#xD;
&#xD;
          -  History of or suspicion for elevated ICP or starting/currently taking high-risk&#xD;
             medications associated with increased risk for elevated ICP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to give consent&#xD;
&#xD;
          -  Over 21 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah K Jones</last_name>
    <role>Study Director</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke UMC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Xu W, Gerety P, Aleman T, Swanson J, Taylor J. Noninvasive methods of detecting increased intracranial pressure. Childs Nerv Syst. 2016 Aug;32(8):1371-86. doi: 10.1007/s00381-016-3143-x. Epub 2016 Jun 28.</citation>
    <PMID>27351182</PMID>
  </reference>
  <reference>
    <citation>Roberts E, Morgan R, King D, Clerkin L. Funduscopy: a forgotten art? Postgrad Med J. 1999 May;75(883):282-4. doi: 10.1136/pgmj.75.883.282.</citation>
    <PMID>10533632</PMID>
  </reference>
  <reference>
    <citation>Sit M, Levin AV. Direct ophthalmoscopy in pediatric emergency care. Pediatr Emerg Care. 2001 Jun;17(3):199-204; quiz 205-7. doi: 10.1097/00006565-200106000-00013.</citation>
    <PMID>11437148</PMID>
  </reference>
  <reference>
    <citation>Petrushkin H, Barsam A, Mavrakakis M, Parfitt A, Jaye P. Optic disc assessment in the emergency department: a comparative study between the PanOptic and direct ophthalmoscopes. Emerg Med J. 2012 Dec;29(12):1007-8. doi: 10.1136/emermed-2011-200038. Epub 2011 Oct 13.</citation>
    <PMID>21998469</PMID>
  </reference>
  <reference>
    <citation>Golshani K, Ebrahim Zadeh M, Farajzadegan Z, Khorvash F. Diagnostic Accuracy of Optic Nerve Ultrasonography and Ophthalmoscopy in Prediction of Elevated Intracranial Pressure. Emerg (Tehran). 2015 Spring;3(2):54-8.</citation>
    <PMID>26495382</PMID>
  </reference>
  <reference>
    <citation>Day LM, Wang SX, Huang CJ. Nonmydriatic Fundoscopic Imaging Using the Pan Optic iExaminer System in the Pediatric Emergency Department. Acad Emerg Med. 2017 May;24(5):587-594. doi: 10.1111/acem.13128. Epub 2017 Mar 24.</citation>
    <PMID>27801997</PMID>
  </reference>
  <reference>
    <citation>Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. doi: 10.2165/00128071-200506010-00004.</citation>
    <PMID>15675888</PMID>
  </reference>
  <reference>
    <citation>Chiu AM, Chuenkongkaew WL, Cornblath WT, Trobe JD, Digre KB, Dotan SA, Musson KH, Eggenberger ER. Minocycline treatment and pseudotumor cerebri syndrome. Am J Ophthalmol. 1998 Jul;126(1):116-21. doi: 10.1016/s0002-9394(98)00063-4.</citation>
    <PMID>9683157</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>December 7, 2021</results_first_submitted>
  <results_first_submitted_qc>January 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2022</results_first_posted>
  <disposition_first_submitted>November 2, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>January 25, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 15, 2022</disposition_first_posted>
  <last_update_submitted>January 25, 2022</last_update_submitted>
  <last_update_submitted_qc>January 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vision screening</keyword>
  <keyword>portable fundus camera</keyword>
  <keyword>acne medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03286426/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vision/Eye Screening</title>
          <description>Image of back of each eye along with color vision and visual acuity assessment if able.&#xD;
Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Vision/Eye Screening</title>
          <description>Image of back of each eye along with color vision and visual acuity assessment if able.&#xD;
Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59" spread="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Posterior Segment as Measured by Fundus Camera</title>
        <time_frame>Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent</time_frame>
        <population>Data not collected as only one visit occurred and a change could not be measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Vision/Eye Screening</title>
            <description>Image of back of each eye along with color vision and visual acuity assessment if able.&#xD;
Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Posterior Segment as Measured by Fundus Camera</title>
          <population>Data not collected as only one visit occurred and a change could not be measured.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Visual Acuity</title>
        <time_frame>Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent</time_frame>
        <population>Data not collected as only one visit occurred and a change could not be measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Vision/Eye Screening</title>
            <description>Image of back of each eye along with color vision and visual acuity assessment if able.&#xD;
Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Visual Acuity</title>
          <population>Data not collected as only one visit occurred and a change could not be measured.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)</title>
        <time_frame>Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent</time_frame>
        <population>Data not collected as only one visit occurred and a change could not be measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Vision/Eye Screening</title>
            <description>Image of back of each eye along with color vision and visual acuity assessment if able.&#xD;
Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)</title>
          <population>Data not collected as only one visit occurred and a change could not be measured.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>At baseline visit as only one visit occurred for each subject.</time_frame>
      <desc>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed as there was only one visit per subject for this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Vision/Eye Screening</title>
          <description>Image of back of each eye along with color vision and visual acuity assessment if able.&#xD;
Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Grace Prakalapakorn</name_or_title>
      <organization>Duke Eye Center</organization>
      <phone>+1 919 684 7679</phone>
      <email>grace.prakalapakorn@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03286426
org study id: Pro00083580
nct id: NCT03286426
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to evaluate the vision and posterior segment of eyes in children
      and young adults less than 22 years of age with risk, suspicion, or past medical history
      significant for elevated intracranial pressure (ICP). Patients will have visual acuity and
      color vision tested. Assessment of the posterior segment will involve using a non-invasive
      (non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital
      settings).
The need for non-invasive evaluation of ICP is an active area of study. The current gold
      standard is intraventricular or intraparenchymal catheters but these are invasive, expensive,
      and require sedation; and thus the need for an effective non-invasive screening tool. The
      utility of funduscopy in identifying processes affecting ICP has long been recognized, i.e.
      papilledema, ocular venous engorgement, blurring of the optic disk. Studies have demonstrated
      that funduscopy may have a role in the qualitative assessment of increased ICP as a highly
      sensitive test. However, conventional bedside funduscopy does not allow for image capture and
      may necessitate pupillary dilation. Portable fundus cameras address these issues, allowing
      image capture and storage and the potential for non-mydriatic imaging, i.e. imaging without
      dilation of eyes. And as demonstrated in a recent study, portable fundus cameras are
      efficient (median exam time was 3 minutes and 24 seconds in a pediatric Emergency
      Department).

      Additionally, ICP screening in asymptomatic patients remains limited. Patients being treated
      with medications for acne, specifically tetracyclines (e.g. minocycline and doxycycline),
      retinol, and isotretinol, are at particular risk for increased ICP but often are not
      identified until they are symptomatic (i.e. headaches, visual loss, papilledema). Symptom
      onset has been documented from 2 weeks up to 1 year from drug initiation. The percentage of
      patients with subclinical asymptomatic disease is unclear. This study would allow us to
      describe the presence of subclinical disease in our population and the role/utility of
      routine non-invasive screening methods.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All patients will have images taken of the back of the eye with a portable fundus camera. If able, visual acuity and color vision will be checked.
primary purpose: Screening
masking: None (Open Label)
measure: Changes in Posterior Segment as Measured by Fundus Camera
time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
measure: Changes in Visual Acuity
time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
measure: Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)
time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
arm group label: Vision/Eye Screening
arm group type: Experimental
description: Image of back of each eye along with color vision and visual acuity assessment if able.
intervention type: Diagnostic Test
intervention name: Pictor
description: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.
arm group label: Vision/Eye Screening
other name: portable fundus camera
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah K Jones
role: Study Director
affiliation: Duke University
facility: 
country: United States
citation: Xu W, Gerety P, Aleman T, Swanson J, Taylor J. Noninvasive methods of detecting increased intracranial pressure. Childs Nerv Syst. 2016 Aug;32(8):1371-86. doi: 10.1007/s00381-016-3143-x. Epub 2016 Jun 28.
PMID: 27351182
citation: Roberts E, Morgan R, King D, Clerkin L. Funduscopy: a forgotten art? Postgrad Med J. 1999 May;75(883):282-4. doi: 10.1136/pgmj.75.883.282.
PMID: 10533632
citation: Sit M, Levin AV. Direct ophthalmoscopy in pediatric emergency care. Pediatr Emerg Care. 2001 Jun;17(3):199-204; quiz 205-7. doi: 10.1097/00006565-200106000-00013.
PMID: 11437148
citation: Petrushkin H, Barsam A, Mavrakakis M, Parfitt A, Jaye P. Optic disc assessment in the emergency department: a comparative study between the PanOptic and direct ophthalmoscopes. Emerg Med J. 2012 Dec;29(12):1007-8. doi: 10.1136/emermed-2011-200038. Epub 2011 Oct 13.
PMID: 21998469
citation: Golshani K, Ebrahim Zadeh M, Farajzadegan Z, Khorvash F. Diagnostic Accuracy of Optic Nerve Ultrasonography and Ophthalmoscopy in Prediction of Elevated Intracranial Pressure. Emerg (Tehran). 2015 Spring;3(2):54-8.
PMID: 26495382
citation: Day LM, Wang SX, Huang CJ. Nonmydriatic Fundoscopic Imaging Using the Pan Optic iExaminer System in the Pediatric Emergency Department. Acad Emerg Med. 2017 May;24(5):587-594. doi: 10.1111/acem.13128. Epub 2017 Mar 24.
PMID: 27801997
citation: Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37. doi: 10.2165/00128071-200506010-00004.
PMID: 15675888
citation: Chiu AM, Chuenkongkaew WL, Cornblath WT, Trobe JD, Digre KB, Dotan SA, Musson KH, Eggenberger ER. Minocycline treatment and pseudotumor cerebri syndrome. Am J Ophthalmol. 1998 Jul;126(1):116-21. doi: 10.1016/s0002-9394(98)00063-4.
PMID: 9683157
responsible party type: Sponsor
mesh term: Intracranial Hypertension
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 