<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/NCT03002688</url>
  </required_header>
  <id_info>
    <org_study_id>2016H0032</org_study_id>
    <nct_id>NCT03002688</nct_id>
  </id_info>
  <brief_title>OSUWMC EEI Sequential Cataract Patient Experience Project</brief_title>
  <official_title>OSUWMC EEI Sequential Cataract Patient Experience Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to gauge the patients' level of comfort and anxiety for sequential cataract&#xD;
      surgeries to assess if the second experience of cataract surgery differs from the initial&#xD;
      experience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each patient is scheduled to undergo two sequential cataract extractions under topical&#xD;
      anesthesia with local anesthetic eye drops and minimal sedation- one on each eye. The&#xD;
      surgeon, basic surgical procedure, anesthetic technique, and approximate length of procedure&#xD;
      are reasonably similar and the patients act as their own control. Subjects in the study will&#xD;
      answer very brief questions regarding anxiety and comfort about their surgery before and&#xD;
      after each procedure, and on the day after their second surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>First and second cataract extraction surgery occuring within 6 weeks</time_frame>
    <description>Pain will be evaluated using verbal survey after each cataract surgery, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in pain between surgeries on the day after the second cataract surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>First and second cataract extraction surgery occuring within 6 weeks</time_frame>
    <description>Anxiety will be evaluated using verbal survey before each cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in anxiety between surgeries on the day after the second cataract surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Awareness</measure>
    <time_frame>First and second cataract extraction surgery occuring within 6 weeks</time_frame>
    <description>Awareness will be evaluated using verbal survey after each cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in awareness between surgeries on the day after the second cataract surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comfort Level</measure>
    <time_frame>First and second cataract extraction surgery occuring within 6 weeks</time_frame>
    <description>Comfort level will be evaluated using verbal survey after cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in comfort level between surgeries on the day after the second cataract surgery.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">286</enrollment>
  <condition>Cataract Surgery Experience</condition>
  <arm_group>
    <arm_group_label>Sequential Cataract Surgery with Survey</arm_group_label>
    <description>Subjects eligible for the study will fall into the sequential cataract surgery group and be administered brief surveys.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>Verbal survey will be given before and after the cataract surgery, and on the day following the second cataract surgery.</description>
    <arm_group_label>Sequential Cataract Surgery with Survey</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be identified by their status presenting for surgery with one specific&#xD;
        surgeon (A.T.) at the Eye and Ear Center at Gowdy Fields. Access will be through the&#xD;
        preoperative anesthesia assessment performed by the attending anesthesiologist.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing sequential cataract surgeries within a 6 week time period&#xD;
             performed by the ophthalmologist, Amit Tandon, MD.&#xD;
&#xD;
          2. Aged 18 years and older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cognitive impairment causing inability to participate in survey&#xD;
&#xD;
          2. Language barrier causing an inability to participate in survey&#xD;
&#xD;
          3. Healthcare POA or guardian leading to an inability to consent to survey&#xD;
&#xD;
          4. Physician autonomy; patients that are inappropriate for the study as deemed by&#xD;
             investigator&#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>Deborah Lowery, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Deborah Lowery</investigator_full_name>
    <investigator_title>Assistant Professor Clinical Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT03002688
org study id: 2016H0032
nct id: NCT03002688
lead sponsor: 
has dmc: No
The purpose is to gauge the patients' level of comfort and anxiety for sequential cataract
      surgeries to assess if the second experience of cataract surgery differs from the initial
      experience.
Each patient is scheduled to undergo two sequential cataract extractions under topical
      anesthesia with local anesthetic eye drops and minimal sedation- one on each eye. The
      surgeon, basic surgical procedure, anesthetic technique, and approximate length of procedure
      are reasonably similar and the patients act as their own control. Subjects in the study will
      answer very brief questions regarding anxiety and comfort about their surgery before and
      after each procedure, and on the day after their second surgery.
observational model: Other
time perspective: Prospective
measure: Pain
time frame: First and second cataract extraction surgery occuring within 6 weeks
description: Pain will be evaluated using verbal survey after each cataract surgery, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in pain between surgeries on the day after the second cataract surgery.
measure: Anxiety
time frame: First and second cataract extraction surgery occuring within 6 weeks
description: Anxiety will be evaluated using verbal survey before each cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in anxiety between surgeries on the day after the second cataract surgery.
measure: Awareness
time frame: First and second cataract extraction surgery occuring within 6 weeks
description: Awareness will be evaluated using verbal survey after each cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in awareness between surgeries on the day after the second cataract surgery.
measure: Comfort Level
time frame: First and second cataract extraction surgery occuring within 6 weeks
description: Comfort level will be evaluated using verbal survey after cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in comfort level between surgeries on the day after the second cataract surgery.
arm group label: Sequential Cataract Surgery with Survey
description: Subjects eligible for the study will fall into the sequential cataract surgery group and be administered brief surveys.
intervention type: Other
intervention name: Survey
description: Verbal survey will be given before and after the cataract surgery, and on the day following the second cataract surgery.
arm group label: Sequential Cataract Surgery with Survey
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: Deborah Lowery, MD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Deborah Lowery
investigator title: Assistant Professor Clinical Anesthesiology
mesh term: Cataract
sharing ipd: No