<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/NCT03247751</url>
  </required_header>
  <id_info>
    <org_study_id>BPF001C</org_study_id>
    <nct_id>NCT03247751</nct_id>
  </id_info>
  <brief_title>Evaluation of the Rotational Stability</brief_title>
  <official_title>Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece 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>
      To evaluate rotational stability of the investigational device implanted after cataract&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary endpoint is angle of intraocular lens rotation between the day of surgery and&#xD;
      postoperative 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">August 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>The intraocular lens rotation</measure>
    <time_frame>postoperative 6 months</time_frame>
    <description>The angle of the intraocular rotation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual acuity</measure>
    <time_frame>postoperative 6 months</time_frame>
    <description>Distance BCVA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>postoperative 6 months</time_frame>
    <description>severity and causal relationship</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>one group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one group receiving NIDEK intraocular lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>intraocular lens</intervention_name>
    <description>Implant NIDEK intraocular lens after cataract surgery</description>
    <arm_group_label>one group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults, 18 years or older&#xD;
&#xD;
          -  Subject who diagnosed unilateral or bilateral age-related cataract.&#xD;
&#xD;
          -  Potential postoperative BCVA of 0.2 log MAR (0.63) or better.&#xD;
&#xD;
          -  Calculated IOL power in within the range of investigational IOL.&#xD;
&#xD;
          -  Subject is able to understand, agree and sign the informed consent statement.&#xD;
&#xD;
          -  Subject is able and willing to comply with the postoperative follow-up examination&#xD;
             schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled systemic or ocular disease.&#xD;
&#xD;
          -  Extremely shallow anterior chamber.&#xD;
&#xD;
          -  Previous intraocular and corneal surgery.&#xD;
&#xD;
          -  Traumatic cataract.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Concurrent participation in another drug and device clinical investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</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>
  <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/NCT03247751
org study id: BPF001C
nct id: NCT03247751
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate rotational stability of the investigational device implanted after cataract
      surgery.
The primary endpoint is angle of intraocular lens rotation between the day of surgery and
      postoperative 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The intraocular lens rotation
time frame: postoperative 6 months
description: The angle of the intraocular rotation.
measure: visual acuity
time frame: postoperative 6 months
description: Distance BCVA
measure: Adverse event
time frame: postoperative 6 months
description: severity and causal relationship
arm group label: one group
arm group type: Experimental
description: one group receiving NIDEK intraocular lens
intervention type: Device
intervention name: intraocular lens
description: Implant NIDEK intraocular lens after cataract surgery
arm group label: one group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No