<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/NCT04443101</url>
  </required_header>
  <id_info>
    <org_study_id>SSOCT-ELP</org_study_id>
    <nct_id>NCT04443101</nct_id>
  </id_info>
  <brief_title>Effective Lens Position After Cataract Surgery</brief_title>
  <official_title>Comparison of Changes in Effective Lens Position of Different Types of Intraocular Lens</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cataract patients were implanted with different types of intraocular lenses for grouping.&#xD;
      SSOCT scanning was used to measure ELP and optometry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cataract patients were implanted with different types of intraocular lenses for grouping.&#xD;
      Perform SSOCT scan that was used to measure effective lens position and optometry at&#xD;
      different postoperative follow-up time .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">March 30, 2023</completion_date>
  <primary_completion_date type="Actual">May 30, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>effective lens position</measure>
    <time_frame>up to 3 months after cataract surgery</time_frame>
    <description>Changes of effective lens position at different time points after cataract surgery</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Age-related Cataract</condition>
  <arm_group>
    <arm_group_label>Group（SN6CWS）</arm_group_label>
    <description>Group（SN6CWS）：Implant SN6CWS intraocular lens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group（MI60）</arm_group_label>
    <description>Group（MI60）：Implant MI60 intraocular lens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group（Aspira-aA）</arm_group_label>
    <description>Group（Aspira-aA）：Implant Aspira-aA intraocular lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>different types of intracular lens</intervention_name>
    <description>different types of intracular lens</description>
    <arm_group_label>Group（Aspira-aA）</arm_group_label>
    <arm_group_label>Group（MI60）</arm_group_label>
    <arm_group_label>Group（SN6CWS）</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Diagnosed as cataract in our hospital;&#xD;
&#xD;
          -  Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;&#xD;
&#xD;
          -  Cataract phacoemulsification and intraocular lens implantation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a.Diagnosed as cataract;&#xD;
&#xD;
          -  b.Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;&#xD;
&#xD;
          -  c.Cataract phacoemulsification and intraocular lens implantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a.Combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye&#xD;
             diseases;&#xD;
&#xD;
          -  b.A history of intraocular surgery or trauma other than cataract surgery;&#xD;
&#xD;
          -  c.Intraoperative complications such as tearing of the capsule and IOL failure to&#xD;
             implant;&#xD;
&#xD;
          -  d.Endophthalmitis, corneal endothelial decompensation and other postoperative&#xD;
             complications;&#xD;
&#xD;
          -  e.Those with incomplete data collected during the follow-up period of postoperative&#xD;
             patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>xixia ding, Phd</last_name>
    <phone>+8613780148109</phone>
    <email>dingxixiaxc@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ophthalmology and Optometry Hospital</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yun-e zhao</last_name>
      <phone>+86 13819707056</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>XIXIA DING, PHD</last_name>
      <phone>86-057788068859</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>March 5, 2023</last_update_submitted>
  <last_update_submitted_qc>March 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>yin ying zhao</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT04443101
org study id: SSOCT-ELP
nct id: NCT04443101
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cataract patients were implanted with different types of intraocular lenses for grouping.
      SSOCT scanning was used to measure ELP and optometry.
Cataract patients were implanted with different types of intraocular lenses for grouping.
      Perform SSOCT scan that was used to measure effective lens position and optometry at
      different postoperative follow-up time .
observational model: Case-Only
time perspective: Prospective
measure: effective lens position
time frame: up to 3 months after cataract surgery
description: Changes of effective lens position at different time points after cataract surgery
arm group label: Group（SN6CWS）
description: Group（SN6CWS）：Implant SN6CWS intraocular lens
arm group label: Group（MI60）
description: Group（MI60）：Implant MI60 intraocular lens
arm group label: Group（Aspira-aA）
description: Group（Aspira-aA）：Implant Aspira-aA intraocular lens
intervention type: Other
intervention name: different types of intracular lens
description: different types of intracular lens
arm group label: Group（Aspira-aA）
arm group label: Group（MI60）
arm group label: Group（SN6CWS）
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: xixia ding, Phd
phone: +8613780148109
email: dingxixiaxc@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: yin ying zhao
investigator title: Principal Investigator
mesh term: Cataract
sharing ipd: No