<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/NCT03761745</url>
  </required_header>
  <id_info>
    <org_study_id>2018Rotation</org_study_id>
    <nct_id>NCT03761745</nct_id>
  </id_info>
  <brief_title>Rotational Stability of Different Intraocular Lenses in The Capsular Bag</brief_title>
  <official_title>Rotational Stability of Different Intraocular Lenses in The Capsular Bag</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 evaluate the rotational stability difference among different intraocular lens. The&#xD;
      rotational stability is evaluated by measurement of rotation of the IOL after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 29, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Alignment of intraocular lens</measure>
    <time_frame>1 day postoperatively</time_frame>
    <description>The alignment of intraocular lens was evaluated by anterior segment photography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alignment of intraocular lens</measure>
    <time_frame>1 week postoperatively</time_frame>
    <description>The alignment of intraocular lens was evaluated by anterior segment photography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alignment of intraocular lens</measure>
    <time_frame>1 month, postoperatively</time_frame>
    <description>The alignment of intraocular lens was evaluated by anterior segment photography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraocular Pressure</measure>
    <time_frame>1 day, 1 week, 1 month, postoperatively</time_frame>
    <description>Intraocular Pressure measured by non-contact tonometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected Visual Acuity (UCVA) at Distance</measure>
    <time_frame>1 day, 1 week, 1 month, postoperatively</time_frame>
    <description>UCVA was determined by subjective refraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Visual Acuity (UCVA) at Distance</measure>
    <time_frame>1 day, 1 week, 1 month, postoperatively</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Intraocular Lens Complication</condition>
  <condition>Phacoemulsification</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who received Femtosecond laser-assisted phacoemulsification surgery in The Eye&#xD;
        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 Femtosecond laser-assisted phacoemulsification surgery with&#xD;
             IntelliAxis-L capsular mark.&#xD;
&#xD;
          -  The operation was smooth and there were no surgical complications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma,&#xD;
             uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.);&#xD;
&#xD;
          -  History of ocular trauma or surgery before this cataract surgery;&#xD;
&#xD;
          -  intraoperative and postoperative complications, such as posterior capsule rupture,&#xD;
             corneal endothelium decompensation;&#xD;
&#xD;
          -  Patients with severe or unstable heart, liver, kidney, lung, endocrine (including&#xD;
             thyroid dysfunction), blood, mental dysfunction and other diseases affect the results&#xD;
             of this study;&#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>
    <phone>8613736995127</phone>
    <email>drxushao@126.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>
    <contact>
      <last_name>AYong Yu, MD.PhD.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</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>Rotational Stability of Different Intraocular Lenses in The Capsular Bag</investigator_title>
  </responsible_party>
  <keyword>Rotation</keyword>
  <keyword>Postoperative Care</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/NCT03761745
org study id: 2018Rotation
nct id: NCT03761745
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the rotational stability difference among different intraocular lens. The
      rotational stability is evaluated by measurement of rotation of the IOL after surgery.
observational model: Cohort
time perspective: Prospective
measure: Alignment of intraocular lens
time frame: 1 day postoperatively
description: The alignment of intraocular lens was evaluated by anterior segment photography
measure: Alignment of intraocular lens
time frame: 1 week postoperatively
description: The alignment of intraocular lens was evaluated by anterior segment photography
measure: Alignment of intraocular lens
time frame: 1 month, postoperatively
description: The alignment of intraocular lens was evaluated by anterior segment photography
measure: Intraocular Pressure
time frame: 1 day, 1 week, 1 month, postoperatively
description: Intraocular Pressure measured by non-contact tonometers
measure: Corrected Visual Acuity (UCVA) at Distance
time frame: 1 day, 1 week, 1 month, postoperatively
description: UCVA was determined by subjective refraction
measure: Uncorrected Visual Acuity (UCVA) at Distance
time frame: 1 day, 1 week, 1 month, postoperatively
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
phone: 8613736995127
email: drxushao@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: A-Yong Yu
investigator title: Rotational Stability of Different Intraocular Lenses in The Capsular Bag
sharing ipd: No