<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/NCT02183831</url>
  </required_header>
  <id_info>
    <org_study_id>1-2014-0010</org_study_id>
    <nct_id>NCT02183831</nct_id>
  </id_info>
  <brief_title>Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension Ring</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was set up to identify clinical outcomes including a refractive shift or change in&#xD;
      IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes&#xD;
      without zonular instability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>Visual acuity measurement using refractive error correction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>refractive error</measure>
    <time_frame>1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior chamber depth</measure>
    <time_frame>3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>obtained with a Scheimpflug imaging system (Pentacam; OCULUS Optikgeräte GmbH, Wetzlar, Germany)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular aberrations</measure>
    <time_frame>1month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>constrast sensitivity</measure>
    <time_frame>3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>measured at five spatial frequencies (1.5, 3, 6, 12, and 18 Hz) using the Optec 6500 vision testing system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>posterior capsular opacity grades</measure>
    <time_frame>3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>graded after dilation of pupil over 6 mm, based on slit lamp examination findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>Visual acuity measurement using refractive error correction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>refractive error</measure>
    <time_frame>3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular aberrations</measure>
    <time_frame>3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring</time_frame>
    <description>measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Capsular tension ring non insertion group</arm_group_label>
    <description>The patients who had same cataract surgery procedure without CTR insertion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capsular tension ring insertion group</arm_group_label>
    <description>The patients who underwent capsular tension ring insertion just before IOL implantation during cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of the capsular tension ring</intervention_name>
    <arm_group_label>Capsular tension ring insertion group</arm_group_label>
    <other_name>a pre-loaded CTR in single use injector was inserted just before IOL implantation during cataract surgery</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who were planned to undergo the cataract surgery in Department of&#xD;
        Ophthalmology, Yonsei University College of Medicine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 40 and 79 years&#xD;
&#xD;
          2. no history of eye surgery or glaucoma&#xD;
&#xD;
          3. a transparent central cornea&#xD;
&#xD;
          4. pupil dilation at the preoperative examination of at least 6.0 mm&#xD;
&#xD;
          5. absence of biomicroscopic signs of pseudoexfoliation&#xD;
&#xD;
          6. normal fundus examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. presence of ocular disease that might affect the visual outcome (e.g., color vision&#xD;
             disturbance, chronic uveitis)&#xD;
&#xD;
          2. presence of ocular disease that might affect contrast sensitivity function (e.g.,&#xD;
             glaucoma, maculopathy, high myopia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 2, 2014</last_update_submitted>
  <last_update_submitted_qc>July 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</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>Cataract</mesh_term>
  </condition_browse>
  <!-- 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/NCT02183831
org study id: 1-2014-0010
nct id: NCT02183831
lead sponsor: 
has dmc: No
This study was set up to identify clinical outcomes including a refractive shift or change in
      IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes
      without zonular instability.
observational model: Case-Control
time perspective: Retrospective
measure: Best corrected visual acuity
time frame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: Visual acuity measurement using refractive error correction
measure: refractive error
time frame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors
measure: Anterior chamber depth
time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: obtained with a Scheimpflug imaging system (Pentacam; OCULUS Optikgeräte GmbH, Wetzlar, Germany)
measure: Ocular aberrations
time frame: 1month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation
measure: constrast sensitivity
time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: measured at five spatial frequencies (1.5, 3, 6, 12, and 18 Hz) using the Optec 6500 vision testing system
measure: posterior capsular opacity grades
time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: graded after dilation of pupil over 6 mm, based on slit lamp examination findings
measure: Best corrected visual acuity
time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: Visual acuity measurement using refractive error correction
measure: refractive error
time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors
measure: Ocular aberrations
time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
description: measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation
arm group label: Capsular tension ring non insertion group
description: The patients who had same cataract surgery procedure without CTR insertion
arm group label: Capsular tension ring insertion group
description: The patients who underwent capsular tension ring insertion just before IOL implantation during cataract surgery
intervention type: Device
intervention name: Insertion of the capsular tension ring
arm group label: Capsular tension ring insertion group
other name: a pre-loaded CTR in single use injector was inserted just before IOL implantation during cataract surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 79 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cataract