<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/NCT03031652</url>
  </required_header>
  <id_info>
    <org_study_id>KNUH</org_study_id>
    <nct_id>NCT03031652</nct_id>
  </id_info>
  <brief_title>Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification</brief_title>
  <official_title>Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Charts of 142 patients who underwent standard phacoemulsification under topical anesthesia&#xD;
      between March and August 2016 were reviewed. The pain during phacoemulsification and 1 h&#xD;
      after surgery was assessed and compared using a visual analog scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients scheduled for elective phacoemulsification and intraocular lens implantation with&#xD;
      the Infiniti Vision System (Alcon, Fort Worth, USA) were included. All operations were&#xD;
      performed in Kyungpook National University Hospital by the same surgeon between March and&#xD;
      August 2016.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">August 31, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score assessed with Visual Analogue Scale (VAS)</measure>
    <time_frame>1 hour after the end of surgery</time_frame>
    <description>Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.&#xD;
A third person assessed subjective pain using a pain visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable) after surgery.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">142</enrollment>
  <condition>Phacoemulsification</condition>
  <arm_group>
    <arm_group_label>Enrolled group</arm_group_label>
    <description>Patients who had senile cataract and underwent phacoemulsification with topical anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phacoemulsification</intervention_name>
    <description>The device device used to provide and perform small profile entry for cataract extraction with or without option of insertion of a specified intraocular lens implant</description>
    <arm_group_label>Enrolled group</arm_group_label>
    <other_name>INFINITI® Vision System</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had senile cataract and needed to receive cataract surgery&#xD;
        (phacoemulsification) under topical anesthesia were included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients underwent phacoemulsification with topical anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who needed general anesthesia or were taking medications capable of affecting&#xD;
             perceived pain&#xD;
&#xD;
          -  Patients who had traumatic cataract and/or conditions likely to require vitrectomy and&#xD;
             trans-scleral fixation of posterior chamber intraocular lens&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Kyun Kim, M.D.,Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Department of ophthalmology, Kyungpook national university hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook national university hospital</name>
      <address>
        <city>Daegu</city>
        <state>Samduk-2ga, Jung-gu</state>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg. 1996 Jun;22(5):612-4. doi: 10.1016/s0886-3350(96)80019-8.</citation>
    <PMID>8784636</PMID>
  </reference>
  <reference>
    <citation>O'Brien PD, Fulcher T, Wallace D, Power W. Patient pain during different stages of phacoemulsification using topical anesthesia. J Cataract Refract Surg. 2001 Jun;27(6):880-3. doi: 10.1016/s0886-3350(00)00757-4.</citation>
    <PMID>11408135</PMID>
  </reference>
  <reference>
    <citation>Ursea R, Feng MT, Zhou M, Lien V, Loeb R. Pain perception in sequential cataract surgery: comparison of first and second procedures. J Cataract Refract Surg. 2011 Jun;37(6):1009-14. doi: 10.1016/j.jcrs.2011.01.020.</citation>
    <PMID>21596244</PMID>
  </reference>
  <reference>
    <citation>Cho YK, Chang HS, Kim MS. Risk factors for endothelial cell loss after phacoemulsification: comparison in different anterior chamber depth groups. Korean J Ophthalmol. 2010 Feb;24(1):10-5. doi: 10.3341/kjo.2010.24.1.10. Epub 2010 Feb 5.</citation>
    <PMID>20157408</PMID>
  </reference>
  <reference>
    <citation>Zauberman H. Extreme deepening of the anterior chamber during phacoemulsification. Ophthalmic Surg. 1992 Aug;23(8):555-6.</citation>
    <PMID>1508488</PMID>
  </reference>
  <reference>
    <citation>Ezra DG, Allan BD. Topical anaesthesia alone versus topical anaesthesia with intracameral lidocaine for phacoemulsification. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005276. doi: 10.1002/14651858.CD005276.pub2.</citation>
    <PMID>17636793</PMID>
  </reference>
  <results_reference>
    <citation>Nahra Saad D, Castilla Cespedes M, Martinez Palmer A, Pazos Lopez M. Phacoemulsification and lens-iris diaphragm retropulsion syndrome. Ophthalmic Surg Lasers Imaging. 2005 Nov-Dec;36(6):512-3.</citation>
    <PMID>16355958</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Hong Kyun Kim, M.D</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>axial length</keyword>
  <keyword>anterior chamber depth</keyword>
  <keyword>intraocular pressure</keyword>
  <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/NCT03031652
org study id: KNUH
nct id: NCT03031652
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Charts of 142 patients who underwent standard phacoemulsification under topical anesthesia
      between March and August 2016 were reviewed. The pain during phacoemulsification and 1 h
      after surgery was assessed and compared using a visual analog scale.
Patients scheduled for elective phacoemulsification and intraocular lens implantation with
      the Infiniti Vision System (Alcon, Fort Worth, USA) were included. All operations were
      performed in Kyungpook National University Hospital by the same surgeon between March and
      August 2016.
observational model: Case-Only
time perspective: Retrospective
measure: Pain score assessed with Visual Analogue Scale (VAS)
time frame: 1 hour after the end of surgery
description: Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
A third person assessed subjective pain using a pain visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable) after surgery.
arm group label: Enrolled group
description: Patients who had senile cataract and underwent phacoemulsification with topical anesthesia.
intervention type: Device
intervention name: Phacoemulsification
description: The device device used to provide and perform small profile entry for cataract extraction with or without option of insertion of a specified intraocular lens implant
arm group label: Enrolled group
other name: INFINITI® Vision System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hong Kyun Kim, M.D.,Ph.D.
role: Study Director
affiliation: Department of ophthalmology, Kyungpook national university hospital
facility: 
country: Korea, Republic of
citation: Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg. 1996 Jun;22(5):612-4. doi: 10.1016/s0886-3350(96)80019-8.
PMID: 8784636
citation: O'Brien PD, Fulcher T, Wallace D, Power W. Patient pain during different stages of phacoemulsification using topical anesthesia. J Cataract Refract Surg. 2001 Jun;27(6):880-3. doi: 10.1016/s0886-3350(00)00757-4.
PMID: 11408135
citation: Ursea R, Feng MT, Zhou M, Lien V, Loeb R. Pain perception in sequential cataract surgery: comparison of first and second procedures. J Cataract Refract Surg. 2011 Jun;37(6):1009-14. doi: 10.1016/j.jcrs.2011.01.020.
PMID: 21596244
citation: Cho YK, Chang HS, Kim MS. Risk factors for endothelial cell loss after phacoemulsification: comparison in different anterior chamber depth groups. Korean J Ophthalmol. 2010 Feb;24(1):10-5. doi: 10.3341/kjo.2010.24.1.10. Epub 2010 Feb 5.
PMID: 20157408
citation: Zauberman H. Extreme deepening of the anterior chamber during phacoemulsification. Ophthalmic Surg. 1992 Aug;23(8):555-6.
PMID: 1508488
citation: Ezra DG, Allan BD. Topical anaesthesia alone versus topical anaesthesia with intracameral lidocaine for phacoemulsification. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005276. doi: 10.1002/14651858.CD005276.pub2.
PMID: 17636793
citation: Nahra Saad D, Castilla Cespedes M, Martinez Palmer A, Pazos Lopez M. Phacoemulsification and lens-iris diaphragm retropulsion syndrome. Ophthalmic Surg Lasers Imaging. 2005 Nov-Dec;36(6):512-3.
PMID: 16355958
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Hong Kyun Kim, M.D
investigator title: Professor
sharing ipd: No