<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/NCT03817151</url>
  </required_header>
  <id_info>
    <org_study_id>xuwen2017-022</org_study_id>
    <nct_id>NCT03817151</nct_id>
  </id_info>
  <brief_title>Clinical Observation of the Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support</brief_title>
  <official_title>Clinical Observation of Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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>
      To present the follow-up outcomes of transscleral suture fixation of posterior chamber&#xD;
      intraocular lens (PCIOL) in eyes with inadequate capsule support.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>Visual function</measure>
    <time_frame>1day postoperation</time_frame>
    <description>Best corrected visual acuity (BCVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>1 week postoperation</time_frame>
    <description>Best corrected visual acuity (BCVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>1 month postoperation</time_frame>
    <description>Best corrected visual acuity (BCVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>3 month postoperation</time_frame>
    <description>Best corrected visual acuity (BCVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>1 day postoperation</time_frame>
    <description>uncorrected distance visual acuity (UDVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>1 week postoperation</time_frame>
    <description>uncorrected distance visual acuity (UDVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>1 month postoperation</time_frame>
    <description>uncorrected distance visual acuity (UDVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>3 month postoperation</time_frame>
    <description>uncorrected distance visual acuity (UDVA) measured using a decimal chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraocular pressure</measure>
    <time_frame>1 day, 1 week, 1 month, and 3 month postoperation</time_frame>
    <description>intraocular pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCIOL tilt degree</measure>
    <time_frame>3 month postoperation</time_frame>
    <description>PCIOL tilt degree measured using Ultrasound biomicroscope</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCIOL decentration degree</measure>
    <time_frame>3 month postoperation</time_frame>
    <description>PCIOL tilt degree measured using Ultrasound biomicroscope</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>endothelial cell count</measure>
    <time_frame>1 week, 1 month, and 3 month postoperation</time_frame>
    <description>endothelial cell count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anterior chamber depth</measure>
    <time_frame>3 month postoperation</time_frame>
    <description>anterior chamber depth measured using Ultrasound biomicroscope</description>
  </secondary_outcome>
  <enrollment type="Actual">21</enrollment>
  <condition>Absence of Capsule Support</condition>
  <condition>Aphakia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>posterior chamber intraocular lens implantation</intervention_name>
    <description>patients who underwent transscleral sutured posterior chamber intraocular lens implantation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent transscleral sutured PCIOL implantation between January 2017 and&#xD;
        August 2018, in Eye Center of the Second Affiliated Hospital, Zhejiang University School of&#xD;
        Medicine, Hangzhou, China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who underwent transscleral suture fixation of PCIOL&#xD;
&#xD;
          2. Time between the primary surgeries was at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active intraocular inflammation&#xD;
&#xD;
          2. The intraocular pressure (IOP) was higher than 25 mmHg&#xD;
&#xD;
          3. The endothelial cell count (ECC) was more than 1,200 cells/mm2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Second Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</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>Aphakia</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/NCT03817151
org study id: xuwen2017-022
nct id: NCT03817151
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To present the follow-up outcomes of transscleral suture fixation of posterior chamber
      intraocular lens (PCIOL) in eyes with inadequate capsule support.
observational model: Case-Only
time perspective: Retrospective
measure: Visual function
time frame: 1day postoperation
description: Best corrected visual acuity (BCVA) measured using a decimal chart
measure: Visual function
time frame: 1 week postoperation
description: Best corrected visual acuity (BCVA) measured using a decimal chart
measure: Visual function
time frame: 1 month postoperation
description: Best corrected visual acuity (BCVA) measured using a decimal chart
measure: Visual function
time frame: 3 month postoperation
description: Best corrected visual acuity (BCVA) measured using a decimal chart
measure: Visual function
time frame: 1 day postoperation
description: uncorrected distance visual acuity (UDVA) measured using a decimal chart
measure: Visual function
time frame: 1 week postoperation
description: uncorrected distance visual acuity (UDVA) measured using a decimal chart
measure: Visual function
time frame: 1 month postoperation
description: uncorrected distance visual acuity (UDVA) measured using a decimal chart
measure: Visual function
time frame: 3 month postoperation
description: uncorrected distance visual acuity (UDVA) measured using a decimal chart
measure: intraocular pressure
time frame: 1 day, 1 week, 1 month, and 3 month postoperation
description: intraocular pressure
measure: PCIOL tilt degree
time frame: 3 month postoperation
description: PCIOL tilt degree measured using Ultrasound biomicroscope
measure: PCIOL decentration degree
time frame: 3 month postoperation
description: PCIOL tilt degree measured using Ultrasound biomicroscope
measure: endothelial cell count
time frame: 1 week, 1 month, and 3 month postoperation
description: endothelial cell count
measure: anterior chamber depth
time frame: 3 month postoperation
description: anterior chamber depth measured using Ultrasound biomicroscope
intervention type: Procedure
intervention name: posterior chamber intraocular lens implantation
description: patients who underwent transscleral sutured posterior chamber intraocular lens implantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Aphakia
sharing ipd: No