<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/NCT01734343</url>
  </required_header>
  <id_info>
    <org_study_id>EK Nr:847/2010</org_study_id>
    <nct_id>NCT01734343</nct_id>
  </id_info>
  <brief_title>Posterior Capsule Opacification Development With Two Different Intraocular Lenses</brief_title>
  <acronym>MIPHY</acronym>
  <official_title>Posterior Capsule Opacification Development and Frequency of Nd:YAG Treatment of Two Microincision IOLs: Hoya iMics Y-60H vs. PhysIOL microAY</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>
      Age-related cataract is the main cause of impaired vision in the elderly population&#xD;
      worldwide.&#xD;
&#xD;
      The only treatment that can restore functional visual ability is cataract surgery where the&#xD;
      opacified crystalline lens is removed by phacoemulsification and an artificial intraocular&#xD;
      lens is implanted into the remaining capsular bag. Cataract operations are generally very&#xD;
      successful, with a low risk of serious complications.&#xD;
&#xD;
      The most common reason for impaired vision after uneventful cataract surgery in otherwise&#xD;
      healthy eyes is the development of posterior capsule opacification (PCO). PCO is a&#xD;
      physiological change (thickening, opacification and clouding) of the capsular bag expected&#xD;
      after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and&#xD;
      cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that&#xD;
      uses a laser to open a central hole in the posterior capsular bag.&#xD;
&#xD;
      Modifications in IOL design and material lead to a decrease in the incidence of PCO.&#xD;
&#xD;
      During the past two decades, refinements in surgical technique were made resulting in today's&#xD;
      small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are&#xD;
      available, many of them similar but of course with some differences in regard to the chemical&#xD;
      composition of the acrylic material and the IOL design.&#xD;
&#xD;
      The purpose of this study is to compare the development of posterior capsule opacification&#xD;
      (PCO) and the frequency of treatment between two different microincision IOLs over a period&#xD;
      of 3 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>posterior capsular opacification (PCO)</measure>
    <time_frame>3 years</time_frame>
    <description>subjective and objective PCO scoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>best corrected visual acuity (BCVA)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nd:YAG rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Posterior Capsule Opacification</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>HOYA iMics Y-60H</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>eyes with implanted intraocular lens HOYA iMics Y-60H</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PhysIOL microAY</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>eyes with implanted intraocular lens PhysIOL microAY</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HOYA iMics Y-60H</intervention_name>
    <description>same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye</description>
    <arm_group_label>HOYA iMics Y-60H</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PhysIOL microAY</intervention_name>
    <description>same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye</description>
    <arm_group_label>PhysIOL microAY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  bilateral age-related cataract&#xD;
&#xD;
          -  good overall physical constitution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous intraocular surgery or ocular trauma&#xD;
&#xD;
          -  intraocular complication like posterior capsular tear&#xD;
&#xD;
          -  glaucoma&#xD;
&#xD;
          -  uveitis&#xD;
&#xD;
          -  corneal diseases, diabetic retinopathy and any other severe retinal pathology that&#xD;
             would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better&#xD;
             unlikely&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rupert Menapace, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology and Optometry of the Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 22, 2012</last_update_submitted>
  <last_update_submitted_qc>November 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Rupert Menapace</investigator_full_name>
    <investigator_title>Ao.Univ.-Prof. Dr.med.univ.</investigator_title>
  </responsible_party>
  <keyword>posterior capsule opacification</keyword>
  <keyword>PCO</keyword>
  <keyword>after cataract</keyword>
  <keyword>intraocular lens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <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/NCT01734343
org study id: EK Nr:847/2010
nct id: NCT01734343
lead sponsor: 
Age-related cataract is the main cause of impaired vision in the elderly population
      worldwide.

      The only treatment that can restore functional visual ability is cataract surgery where the
      opacified crystalline lens is removed by phacoemulsification and an artificial intraocular
      lens is implanted into the remaining capsular bag. Cataract operations are generally very
      successful, with a low risk of serious complications.

      The most common reason for impaired vision after uneventful cataract surgery in otherwise
      healthy eyes is the development of posterior capsule opacification (PCO). PCO is a
      physiological change (thickening, opacification and clouding) of the capsular bag expected
      after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and
      cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that
      uses a laser to open a central hole in the posterior capsular bag.

      Modifications in IOL design and material lead to a decrease in the incidence of PCO.

      During the past two decades, refinements in surgical technique were made resulting in today's
      small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are
      available, many of them similar but of course with some differences in regard to the chemical
      composition of the acrylic material and the IOL design.

      The purpose of this study is to compare the development of posterior capsule opacification
      (PCO) and the frequency of treatment between two different microincision IOLs over a period
      of 3 years.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: posterior capsular opacification (PCO)
time frame: 3 years
description: subjective and objective PCO scoring
measure: best corrected visual acuity (BCVA)
time frame: 3 years
measure: Nd:YAG rate
time frame: 3 years
arm group label: HOYA iMics Y-60H
arm group type: Other
description: eyes with implanted intraocular lens HOYA iMics Y-60H
arm group label: PhysIOL microAY
arm group type: Other
description: eyes with implanted intraocular lens PhysIOL microAY
intervention type: Device
intervention name: HOYA iMics Y-60H
description: same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
arm group label: HOYA iMics Y-60H
intervention type: Device
intervention name: PhysIOL microAY
description: same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye
arm group label: PhysIOL microAY
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Rupert Menapace, Prof. Dr.
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Rupert Menapace
investigator title: Ao.Univ.-Prof. Dr.med.univ.
mesh term: Cataract
mesh term: Capsule Opacification