<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/NCT04476264</url>
  </required_header>
  <id_info>
    <org_study_id>TR2019IOL</org_study_id>
    <nct_id>NCT04476264</nct_id>
  </id_info>
  <brief_title>Novel Use of an Adjustable Single 8-0 Polypropylene Suture of Scleral Fixation Without Conjunctival Dissection</brief_title>
  <official_title>Novel Use of an Adjustable Single 8-0 Polypropylene Suture of Scleral Fixation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tongren Hospital</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>
      1. observe the effectivity of an adjustable single 8-0 polypropylene suture to scleral fix&#xD;
           without conjunctival dissection for the treatment with aphakia or inadequate posterior&#xD;
           capsule support.&#xD;
&#xD;
        2. observe the complication of this surgery method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 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>uncorrected VA</measure>
    <time_frame>at 3 months postoperatively</time_frame>
    <description>preoperative and postoperative uncorrected VA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>follow up time is larger 6 month</time_frame>
    <description>Postoperative complications during the follow-up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>IOL and tunnel location</measure>
    <time_frame>at 2 months postoperatively</time_frame>
    <description>IOL tunnels containing sutures were clearly visible by UBM</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Suture, Complication</condition>
  <arm_group>
    <arm_group_label>transscleral IOL fixation</arm_group_label>
    <description>the use of a novel adjustable single 8-0 polypropylene suture for scleral fixation without conjunctival dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection</intervention_name>
    <description>The present study serves to describe a novel approach to utilizing a single adjustable 8-0 polypropylene suture for scleral fixation without conjunctival dissection and to evaluate safety and efficacy outcomes associated with this technique.</description>
    <arm_group_label>transscleral IOL fixation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any participants who used an adjustable single 8-0 polypropylene suture of scleral fixation&#xD;
        without conjunctival dissection could be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patients who used an adjustable single 8-0 polypropylene suture of scleral&#xD;
             fixation without conjunctival dissection could be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Data from patients with a &lt; 6-month postoperative follow-up or with incomplete&#xD;
             operative or postoperative medical records were excluded from this study. Enrolled&#xD;
             patients had complete records pertaining to their visual acuity (VA), slit-lamp&#xD;
             photographs, and ultrasound biomicroscope (UBM) findings.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04476264
org study id: TR2019IOL
nct id: NCT04476264
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. observe the effectivity of an adjustable single 8-0 polypropylene suture to scleral fix
           without conjunctival dissection for the treatment with aphakia or inadequate posterior
           capsule support.

        2. observe the complication of this surgery method.
observational model: Case-Only
time perspective: Retrospective
measure: uncorrected VA
time frame: at 3 months postoperatively
description: preoperative and postoperative uncorrected VA
measure: Postoperative complications
time frame: follow up time is larger 6 month
description: Postoperative complications during the follow-up
measure: IOL and tunnel location
time frame: at 2 months postoperatively
description: IOL tunnels containing sutures were clearly visible by UBM
arm group label: transscleral IOL fixation
description: the use of a novel adjustable single 8-0 polypropylene suture for scleral fixation without conjunctival dissection
intervention type: Procedure
intervention name: Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection
description: The present study serves to describe a novel approach to utilizing a single adjustable 8-0 polypropylene suture for scleral fixation without conjunctival dissection and to evaluate safety and efficacy outcomes associated with this technique.
arm group label: transscleral IOL fixation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor