<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/NCT03831074</url>
  </required_header>
  <id_info>
    <org_study_id>933/2011</org_study_id>
    <nct_id>NCT03831074</nct_id>
  </id_info>
  <brief_title>Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses</brief_title>
  <official_title>Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <brief_summary>
    <textblock>
      The most frequent long-term complication of cataract surgery remains to be posterior capsule&#xD;
      opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized&#xD;
      lens material and design were introduced. We propose a study comparing three acrylic&#xD;
      single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA&#xD;
      Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are&#xD;
      used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a&#xD;
      comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL&#xD;
      decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively&#xD;
      scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the&#xD;
      investigated IOLs will be performed. Since PCO develops slowly within years, a long-term&#xD;
      follow-up of three years will be necessary.&#xD;
&#xD;
      As those IOLs are currently often implanted IOLs, their performance on PCO development and&#xD;
      their optical quality is of high interest for the ophthalmologic community.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2012</start_date>
  <completion_date type="Actual">July 7, 2015</completion_date>
  <primary_completion_date type="Actual">July 7, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Posterior capsule opacification</measure>
    <time_frame>3 years</time_frame>
    <description>Posterior capsule opacification in the 2 IOLs will be assessed with semi automated quantification of cataract software</description>
  </primary_outcome>
  <condition>Posterior Capsule Opacification</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of an intraocular lenses: iMics 1 NY-60 &amp; NY-60G</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bilateral age-related cataract for which phacoemulsification extraction and posterior&#xD;
             IOL implantation has planned&#xD;
&#xD;
          -  Age 40 and older&#xD;
&#xD;
          -  Visual potential in both eyes of 20/30 or better as determined by investigators&#xD;
             estimation&#xD;
&#xD;
          -  Normal findings in the medical history and physical examination unless the&#xD;
             investigator considers an abnormality to be clinically irrelevant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preceding ocular surgery or trauma&#xD;
&#xD;
          -  Relevant other ophthalmic diseases (such as pseudoexfoliation, retinal degenerations,&#xD;
             etc.)&#xD;
&#xD;
          -  Uncontrolled systemic or ocular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katharina Kriechbaum</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Katharina Kriechbaum</investigator_full_name>
    <investigator_title>Assoc. Prof. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capsule Opacification</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/NCT03831074
org study id: 933/2011
nct id: NCT03831074
lead sponsor: 
The most frequent long-term complication of cataract surgery remains to be posterior capsule
      opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized
      lens material and design were introduced. We propose a study comparing three acrylic
      single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA
      Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are
      used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a
      comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL
      decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively
      scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the
      investigated IOLs will be performed. Since PCO develops slowly within years, a long-term
      follow-up of three years will be necessary.

      As those IOLs are currently often implanted IOLs, their performance on PCO development and
      their optical quality is of high interest for the ophthalmologic community.
measure: Posterior capsule opacification
time frame: 3 years
description: Posterior capsule opacification in the 2 IOLs will be assessed with semi automated quantification of cataract software
intervention type: Device
intervention name: Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Katharina Kriechbaum
role: Principal Investigator
affiliation: Medical University of Vienna
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Katharina Kriechbaum
investigator title: Assoc. Prof. Dr.
mesh term: Capsule Opacification