<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/NCT03299530</url>
  </required_header>
  <id_info>
    <org_study_id>2017ASTIGMATISM REGIONS</org_study_id>
    <nct_id>NCT03299530</nct_id>
  </id_info>
  <brief_title>Accuracy of Corneal Astigmatism in Different Region Modes</brief_title>
  <official_title>Accuracy of Corneal Astigmatism in Different Region Modes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</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>
      To analyze the difference between measured total corneal astigmatism and actual corneal&#xD;
      astigmatism under different region modes and optimize the region setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Anticipated">October 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2024</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Vectorial difference</measure>
    <time_frame>≥1 month after surgery</time_frame>
    <description>The vectorial difference between measured corneal astigmatism (under multiple different region mode settings) and actual corneal astigmatism.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pupil size</measure>
    <time_frame>≥1 month after surgery</time_frame>
    <description>pupil size of patients in a bright environment measured by itrace device and MONCV3 device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pupil size 2</measure>
    <time_frame>≥1 month after surgery</time_frame>
    <description>pupil size of patients measured by Pentacam HR device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>residual astigmatism</measure>
    <time_frame>≥1 month after surgery</time_frame>
    <description>residual astigmatism tested by subjective refraction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total corneal astigmatism</measure>
    <time_frame>≥1 month after surgery</time_frame>
    <description>Total corneal astigmatism measured by a scheimpflug tomographer under different region mode settings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior chamber depth</measure>
    <time_frame>≥1 month after surgery</time_frame>
    <description>The distance between corneal apex and anterior surface of IOL measured by a scheimpflug tomographer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>actual corneal astigmatism</measure>
    <time_frame>≥1 month after surgery</time_frame>
    <description>actual corneal astigmatism is derived from residual astigmatism at corneal plane and cylindrical power of IOL at corneal plane through Holladay 2 formula.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Astigmatism</condition>
  <condition>Cornea</condition>
  <arm_group>
    <arm_group_label>patients with corneal astigmatism</arm_group_label>
    <description>Patients who had received phacoemulsification surgery with or without implantation of toric IOL are with a certain amount of corneal astigmatism.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patients with corneal astigmatism</intervention_name>
    <description>The total corneal astigmatism, anterior chamber depth, will be measured by a Scheimpflug tomographer. Pupil size will be measured by itrace device and MONCV3 device. Residual astigmatism will be tested by subjective refraction.</description>
    <arm_group_label>patients with corneal astigmatism</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who received cataract surgery in The Eye Hospital of Wenzhou Medical University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patients who had received phacoemulsification surgery with or without implantation of&#xD;
             toric IOL are with a certain amount of corneal astigmatism.&#xD;
&#xD;
          -  Best corrected visual acuity ≥ 0.66 (20/30 Snellen)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corneal diseases or severe irregular astigmatism (e.g., pterygium, keratoconus),&#xD;
             existence of corneal opacification;&#xD;
&#xD;
          -  Ocular disease which may affect visual acuity (e.g., glaucoma, uveitis, retinal&#xD;
             disease, pathologic myopia);&#xD;
&#xD;
          -  History of ocular surgery or ocular trauma before this cataract surgery;&#xD;
&#xD;
          -  Decentration of IOL &gt; 0.3mm or tilt &gt; 5°&#xD;
&#xD;
          -  Implantation of multifocal IOL&#xD;
&#xD;
          -  history of wearing of rigid contact lens within the past 4 weeks or soft contact lens&#xD;
             within 1 week;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AYong Yu, MD.PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>AYong Yu, MD.PhD.</last_name>
    <phone>+86-0577-88068880</phone>
    <email>yaybetter@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xu Shao, MD</last_name>
    <email>564056712@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Eye Hispital of Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>A-Yong Yu</investigator_full_name>
    <investigator_title>Director of the Cataract Clinical Center</investigator_title>
  </responsible_party>
  <keyword>Corneal Astigmatism</keyword>
  <keyword>Scheimpflug</keyword>
  <keyword>pupil size</keyword>
  <keyword>Toric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Astigmatism</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/NCT03299530
org study id: 2017ASTIGMATISM REGIONS
nct id: NCT03299530
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To analyze the difference between measured total corneal astigmatism and actual corneal
      astigmatism under different region modes and optimize the region setting.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Vectorial difference
time frame: ≥1 month after surgery
description: The vectorial difference between measured corneal astigmatism (under multiple different region mode settings) and actual corneal astigmatism.
measure: pupil size
time frame: ≥1 month after surgery
description: pupil size of patients in a bright environment measured by itrace device and MONCV3 device
measure: pupil size 2
time frame: ≥1 month after surgery
description: pupil size of patients measured by Pentacam HR device
measure: residual astigmatism
time frame: ≥1 month after surgery
description: residual astigmatism tested by subjective refraction
measure: total corneal astigmatism
time frame: ≥1 month after surgery
description: Total corneal astigmatism measured by a scheimpflug tomographer under different region mode settings.
measure: Anterior chamber depth
time frame: ≥1 month after surgery
description: The distance between corneal apex and anterior surface of IOL measured by a scheimpflug tomographer
measure: actual corneal astigmatism
time frame: ≥1 month after surgery
description: actual corneal astigmatism is derived from residual astigmatism at corneal plane and cylindrical power of IOL at corneal plane through Holladay 2 formula.
arm group label: patients with corneal astigmatism
description: Patients who had received phacoemulsification surgery with or without implantation of toric IOL are with a certain amount of corneal astigmatism.
intervention type: Other
intervention name: patients with corneal astigmatism
description: The total corneal astigmatism, anterior chamber depth, will be measured by a Scheimpflug tomographer. Pupil size will be measured by itrace device and MONCV3 device. Residual astigmatism will be tested by subjective refraction.
arm group label: patients with corneal astigmatism
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AYong Yu, MD.PhD.
role: Principal Investigator
affiliation: Wenzhou Medical University
last name: AYong Yu, MD.PhD.
phone: +86-0577-88068880
email: yaybetter@hotmail.com
last name: Xu Shao, MD
email: 564056712@qq.com
facility: 
status: Recruiting
country: China
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: A-Yong Yu
investigator title: Director of the Cataract Clinical Center
mesh term: Astigmatism
sharing ipd: No