<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/NCT03242486</url>
  </required_header>
  <id_info>
    <org_study_id>TIOL-YST</org_study_id>
    <nct_id>NCT03242486</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Toric Intraocular Lens</brief_title>
  <official_title>Safety and Effectiveness Evaluation of Toric Intraocular Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nidek Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nidek Co. LTD.</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>
      Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal&#xD;
      astigmatism after cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effectiveness&#xD;
&#xD;
        -  primary endpoint is visual acuity with pre-determined spherical correction.&#xD;
&#xD;
        -  secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder&#xD;
           Correction, Spherical Equivalent, IOL rotation&#xD;
&#xD;
      Safety&#xD;
&#xD;
        -  number and percentage of adverse event&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>postoperative 6 months</time_frame>
    <description>Visual acuity with pre-determined spherical correction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>postoperative 6 months</time_frame>
    <description>UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOL rotation</measure>
    <time_frame>postoperative 6 months</time_frame>
    <description>angle of rotation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>one year</time_frame>
    <description>Severity and causal relationship</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Cataract</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>toric intraocular lens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>toric intraocular lens is implanted to all subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>toric intraocular lens</intervention_name>
    <arm_group_label>toric intraocular lens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with age of 40 years or older&#xD;
&#xD;
          -  Patients with age-related cataract in one eye or both eyes.&#xD;
&#xD;
          -  Patients willing to participate in the required postoperative study.&#xD;
&#xD;
          -  Patient who can understand and sign the consent document.&#xD;
&#xD;
          -  An eye whose pupil diameter after mydriasis is 5 mm or greater.&#xD;
&#xD;
          -  An eye whose preoperative corneal cylindrical power is 1.0D or more.&#xD;
&#xD;
          -  An eye whose postoperative astigmatism is predicted to be less than 0.5 D.&#xD;
&#xD;
          -  An eye whose postoperative visual acuity with spherical addition is 0.8 D or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disorder of corneal endothelium&#xD;
&#xD;
          -  Uncontrolled glaucoma&#xD;
&#xD;
          -  Active Uveitis&#xD;
&#xD;
          -  Diabetic retinopathy&#xD;
&#xD;
          -  Retinal detachment&#xD;
&#xD;
          -  Congenital ocular anomalies&#xD;
&#xD;
          -  Choroidal hemorrhage&#xD;
&#xD;
          -  Shallow anterior chamber&#xD;
&#xD;
          -  Microphthalmus&#xD;
&#xD;
          -  Corneal dystrophy&#xD;
&#xD;
          -  Optic atrophy&#xD;
&#xD;
          -  Ocular hypertension&#xD;
&#xD;
          -  Amblyopia&#xD;
&#xD;
          -  Previous history of corneal transplantation&#xD;
&#xD;
          -  Active Iritis&#xD;
&#xD;
          -  Corneal disorder&#xD;
&#xD;
          -  Macular degeneration&#xD;
&#xD;
          -  Retinal degeneration&#xD;
&#xD;
          -  Clinically significant change in macula and/or retinal pigment epithelium&#xD;
&#xD;
          -  Corneal irregular astigmatism&#xD;
&#xD;
          -  Atopic disease&#xD;
&#xD;
          -  Brittleness of Zinn's zonule, fractured zonule and lens luxation (including&#xD;
             subluxation)&#xD;
&#xD;
          -  Pseudo-exfoliation syndrome&#xD;
&#xD;
          -  Iris neovascularization&#xD;
&#xD;
          -  Long axis length eye (axis length : 28mm or more)&#xD;
&#xD;
          -  Severe dry eye, abnormality of the lens surface&#xD;
&#xD;
          -  Concurrent participation in another drug and device clinical investigation&#xD;
&#xD;
          -  Patient with mental deficiency or psychiatric disorder and/or who is not capable of&#xD;
             expressing the consent of participating in the trial&#xD;
&#xD;
          -  Patient who is judged inappropriate by investigators or sub-investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>June 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>February 18, 2018</last_update_submitted>
  <last_update_submitted_qc>February 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</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>
    <mesh_term>Astigmatism</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/NCT03242486
org study id: TIOL-YST
nct id: NCT03242486
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal
      astigmatism after cataract surgery.
Effectiveness

        -  primary endpoint is visual acuity with pre-determined spherical correction.

        -  secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder
           Correction, Spherical Equivalent, IOL rotation

      Safety

        -  number and percentage of adverse event
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual acuity
time frame: postoperative 6 months
description: Visual acuity with pre-determined spherical correction
measure: Visual acuity
time frame: postoperative 6 months
description: UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent
measure: IOL rotation
time frame: postoperative 6 months
description: angle of rotation
measure: Adverse events
time frame: one year
description: Severity and causal relationship
arm group label: toric intraocular lens
arm group type: Experimental
description: toric intraocular lens is implanted to all subjects
intervention type: Device
intervention name: toric intraocular lens
arm group label: toric intraocular lens
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cataract
mesh term: Astigmatism
sharing ipd: No