<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/NCT03766230</url>
  </required_header>
  <id_info>
    <org_study_id>YFZX2018006</org_study_id>
    <nct_id>NCT03766230</nct_id>
  </id_info>
  <brief_title>Clinical Study on Second-eye Pain in Cataract Surgery</brief_title>
  <official_title>Subclinical Sympathetic Response Related to Second-eye Pain in Cataract Surgery and Its Noninvasive Detection Index</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Eye Disease Prevention and Treatment Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Eye Disease Prevention and Treatment Center</source>
  <brief_summary>
    <textblock>
      The degree of perceived pain in the second-eye surgery of cataract patients is significantly&#xD;
      higher than that in the first-eye surgery, which can lead to nervous tension during surgery&#xD;
      and affect the surgical outcome and satisfaction. Study suggested that in addition to&#xD;
      psychological factors, there might be subclinical sympathetic reactions leading to increased&#xD;
      pain in the second-eyes, but the objective indicators and clinical relevance are not clear.&#xD;
      Therefore, it is necessary to study the mechanism of second-eye pain in cataract surgery, and&#xD;
      to provide a test index that can effectively predict the degree of intraoperative pain in&#xD;
      patients, as an important reference for the development of a suitable time for second eye&#xD;
      surgery.&#xD;
&#xD;
      This study is based on clinical case studies, recruiting patients with clinically diagnosed&#xD;
      binocular age-related cataract and require binocular surgery, to compare the correlation of&#xD;
      intraocular inflammatory factors in the second eye and patients' self-pain scores while both&#xD;
      eyes' surgery are completed by the same doctor in the same operating room, and the&#xD;
      correlation of the change of inflammatory factors and the time interval between the two eyes&#xD;
      surgery, to analyze the second-eye subclinical sympathetic reaction changing with the time&#xD;
      interval after the first cataract surgery from the molecular biological results. Using the&#xD;
      latest international anterior segment vascularization optical coherence tomography(OCT) scan&#xD;
      and optical microvascular imaging(OMAG) analysis technology to quantify iris blood flow, this&#xD;
      study analyzes the iris blood flow density, vascular density and other indicators before and&#xD;
      after cataract surgery, and carry out its correlation with the degree of intraocular&#xD;
      subclinical sympathetic reaction, providing a rapid, non-invasive objective examination index&#xD;
      of the second-eye subclinical sympathetic response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Coordination and Quality Control Team: The inspection and audit of this research project&#xD;
           will be established mainly by hospital clinical research center staff and assisted by&#xD;
           the Ophthalmology Reading Center team;&#xD;
&#xD;
        2. The project team member will accept training before the study begins while unified&#xD;
           inspection methods and requirements is established in standard operating procedures.&#xD;
&#xD;
        3. The project team double enter the test data independently and establishes an electronic&#xD;
           database.&#xD;
&#xD;
        4. The project team randomly selects the data and repeats the measurements to ensure the&#xD;
           accuracy as internal audit regularly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 30, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2021</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>Change in Surgery Pain Severity Score</measure>
    <time_frame>Within one hour after first eye surgery; within one hour after second eye surgery (performed up to 90 days after first eye surgery)</time_frame>
    <description>visual analogue scale is used to assess the surgery pain. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients. A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling, the position of the respondent's cross is generally assigned a score between 0 and 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Concentration of inflammatory factors in aqueous humor</measure>
    <time_frame>aqueous humor is acquired at the beginning of the first eye surgery and the second eye surgery (performed up to 90 days after first eye surgery)</time_frame>
    <description>the Concentrations of tumor necrosis factor-α,interleukin-1,interleukin-6,interleukin-8,monocyte chemotactic protein-1,interleukin2,macrophage inflammatory protein-1α,macrophage inflammatory protein-1,carbon tetrachloride ,chemokine ligand 9,Tissue inhibitor of matrix metalloproteinase 01,C-C motif chemokine 11 are measured using Luminex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood flow density of iris vascular</measure>
    <time_frame>Within 24 hours before first eye surgery and Day 1, Week 1, Week 3, Month 1, Month 3 after first eye surgery, or within 24 hours before second-eye surgery (performed up to 90 days after first eye surgery)</time_frame>
    <description>CIRRUS High Definition-OCT 5000(Carl Zeiss Meditec, Dublin, CA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in vascular density of iris vascular</measure>
    <time_frame>Within 24 hours before first eye surgery and Day 1, Week 1, Week 3, Month 1, Month 3 after first eye surgery, or within 24 hours before second-eye surgery (performed up to 90 days after first eye surgery)</time_frame>
    <description>CIRRUS High Definition-OCT 5000(Carl Zeiss Meditec, Dublin, CA)</description>
  </secondary_outcome>
  <number_of_groups>10</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Senile Cataract</condition>
  <arm_group>
    <arm_group_label>peribulbar anesthesia1</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is or less than 14 days and using peribulbar anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical anesthesia1</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is or less than 14 days and using topical anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>peribulbar anesthesia2</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is from 15 to 21 days and using peribulbar anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical anesthesia2</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is from 15 to 21 days and using topical anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>peribulbar anesthesia3</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is from 22 to 28 days and using peribulbar anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical anesthesia3</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is from 22 to 28 days and using topical anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>peribulbar anesthesia4</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is from 29 to 60 days and using peribulbar anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical anesthesia4</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is from 29 to 60 days and using topical anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>peribulbar anesthesia5</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is from 61 to 90 days and using peribulbar anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical anesthesia5</arm_group_label>
    <description>Time interval between two eyes' cataract surgery is from 61 to 90 days and using topical anesthesia</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The aqueous humor will be obtained in the surgery and kept in centrifugal tube. The amount of&#xD;
      inflammatory cytokines will be measured afterwards.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Binocular senile cataract patients with binocular phacoemulsification and intraocular lens&#xD;
        implantation to be performed at the Department of Ophthalmology in Shanghai Eye Disease&#xD;
        Prevention and Treatment Center or Shanghai General Hospital from August 2018 to August&#xD;
        2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosed with binocular age-related cataract.&#xD;
&#xD;
          2. Both eyes require phacoemulsification and intraocular lens implantation.&#xD;
&#xD;
          3. binocular surgery was performed by the same physician in the same operating room, and&#xD;
             the anesthesia and surgical procedures were consistent.&#xD;
&#xD;
          4. Patients can fully understand the research purpose, research content, accidents and&#xD;
             benefits and risks of the clinical trial, and can make their own decisions on&#xD;
             participating or not.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Eye Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03766230
org study id: YFZX2018006
nct id: NCT03766230
lead sponsor: 
collaborator: 
The degree of perceived pain in the second-eye surgery of cataract patients is significantly
      higher than that in the first-eye surgery, which can lead to nervous tension during surgery
      and affect the surgical outcome and satisfaction. Study suggested that in addition to
      psychological factors, there might be subclinical sympathetic reactions leading to increased
      pain in the second-eyes, but the objective indicators and clinical relevance are not clear.
      Therefore, it is necessary to study the mechanism of second-eye pain in cataract surgery, and
      to provide a test index that can effectively predict the degree of intraoperative pain in
      patients, as an important reference for the development of a suitable time for second eye
      surgery.

      This study is based on clinical case studies, recruiting patients with clinically diagnosed
      binocular age-related cataract and require binocular surgery, to compare the correlation of
      intraocular inflammatory factors in the second eye and patients' self-pain scores while both
      eyes' surgery are completed by the same doctor in the same operating room, and the
      correlation of the change of inflammatory factors and the time interval between the two eyes
      surgery, to analyze the second-eye subclinical sympathetic reaction changing with the time
      interval after the first cataract surgery from the molecular biological results. Using the
      latest international anterior segment vascularization optical coherence tomography(OCT) scan
      and optical microvascular imaging(OMAG) analysis technology to quantify iris blood flow, this
      study analyzes the iris blood flow density, vascular density and other indicators before and
      after cataract surgery, and carry out its correlation with the degree of intraocular
      subclinical sympathetic reaction, providing a rapid, non-invasive objective examination index
      of the second-eye subclinical sympathetic response.
1. Coordination and Quality Control Team: The inspection and audit of this research project
           will be established mainly by hospital clinical research center staff and assisted by
           the Ophthalmology Reading Center team;

        2. The project team member will accept training before the study begins while unified
           inspection methods and requirements is established in standard operating procedures.

        3. The project team double enter the test data independently and establishes an electronic
           database.

        4. The project team randomly selects the data and repeats the measurements to ensure the
           accuracy as internal audit regularly.
observational model: Cohort
time perspective: Prospective
measure: Change in Surgery Pain Severity Score
time frame: Within one hour after first eye surgery; within one hour after second eye surgery (performed up to 90 days after first eye surgery)
description: visual analogue scale is used to assess the surgery pain. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients. A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling, the position of the respondent's cross is generally assigned a score between 0 and 100.
measure: Change in Concentration of inflammatory factors in aqueous humor
time frame: aqueous humor is acquired at the beginning of the first eye surgery and the second eye surgery (performed up to 90 days after first eye surgery)
description: the Concentrations of tumor necrosis factor-α,interleukin-1,interleukin-6,interleukin-8,monocyte chemotactic protein-1,interleukin2,macrophage inflammatory protein-1α,macrophage inflammatory protein-1,carbon tetrachloride ,chemokine ligand 9,Tissue inhibitor of matrix metalloproteinase 01,C-C motif chemokine 11 are measured using Luminex
measure: Change in blood flow density of iris vascular
time frame: Within 24 hours before first eye surgery and Day 1, Week 1, Week 3, Month 1, Month 3 after first eye surgery, or within 24 hours before second-eye surgery (performed up to 90 days after first eye surgery)
description: CIRRUS High Definition-OCT 5000(Carl Zeiss Meditec, Dublin, CA)
measure: Change in vascular density of iris vascular
time frame: Within 24 hours before first eye surgery and Day 1, Week 1, Week 3, Month 1, Month 3 after first eye surgery, or within 24 hours before second-eye surgery (performed up to 90 days after first eye surgery)
description: CIRRUS High Definition-OCT 5000(Carl Zeiss Meditec, Dublin, CA)
arm group label: peribulbar anesthesia1
description: Time interval between two eyes' cataract surgery is or less than 14 days and using peribulbar anesthesia
arm group label: topical anesthesia1
description: Time interval between two eyes' cataract surgery is or less than 14 days and using topical anesthesia
arm group label: peribulbar anesthesia2
description: Time interval between two eyes' cataract surgery is from 15 to 21 days and using peribulbar anesthesia
arm group label: topical anesthesia2
description: Time interval between two eyes' cataract surgery is from 15 to 21 days and using topical anesthesia
arm group label: peribulbar anesthesia3
description: Time interval between two eyes' cataract surgery is from 22 to 28 days and using peribulbar anesthesia
arm group label: topical anesthesia3
description: Time interval between two eyes' cataract surgery is from 22 to 28 days and using topical anesthesia
arm group label: peribulbar anesthesia4
description: Time interval between two eyes' cataract surgery is from 29 to 60 days and using peribulbar anesthesia
arm group label: topical anesthesia4
description: Time interval between two eyes' cataract surgery is from 29 to 60 days and using topical anesthesia
arm group label: peribulbar anesthesia5
description: Time interval between two eyes' cataract surgery is from 61 to 90 days and using peribulbar anesthesia
arm group label: topical anesthesia5
description: Time interval between two eyes' cataract surgery is from 61 to 90 days and using topical anesthesia
The aqueous humor will be obtained in the surgery and kept in centrifugal tube. The amount of
      inflammatory cytokines will be measured afterwards.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cataract
mesh term: Eye Pain
sharing ipd: Undecided