<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/NCT01732484</url>
  </required_header>
  <id_info>
    <org_study_id>EK1444/2012</org_study_id>
    <nct_id>NCT01732484</nct_id>
  </id_info>
  <brief_title>Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two Microincision IOLs: Hoya iMics NY-60 vs Acrysof SN60WF</brief_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. In the UK, more than half of people who are over 65 have some cataract development&#xD;
      in one or both eyes. The only treatment that can restore functional visual ability is&#xD;
      cataract surgery where the opacified crystalline lens is removed by phacoemulsification and&#xD;
      an artificial intraocular lens is implanted. It is estimated that around 10 million cataract&#xD;
      operations are performed around the world each year. Cataract operations are generally very&#xD;
      successful, with a low risk of serious complications. The most common risk is developing a&#xD;
      condition called posterior capsule opacification (PCO), which causes impaired vision to&#xD;
      return.&#xD;
&#xD;
      During the past two decades, cataract surgery underwent tremendous change and modernisation&#xD;
      resulting in today's small incision phacoemulsification surgery and a safe technique with a&#xD;
      short rehabilitation time for the patient. The most frequent long-term complication of&#xD;
      cataract surgery remains to be posterior capsule opacification (PCO). In the past few years,&#xD;
      refinements in surgical technique and modifications in IOL design and material have led to a&#xD;
      decrease in the incidence of PCO.&#xD;
&#xD;
      It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial&#xD;
      cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule&#xD;
      opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic&#xD;
      towards the end of the production process, also called multipiece designs.&#xD;
&#xD;
      For several reasons such as better ease of use with injector systems and higher efficiency in&#xD;
      the production process, companies have developed IOLs with open-loop haptics out of one block&#xD;
      of material, also called single-piece designs. In the case of such single-piece IOLs, the&#xD;
      haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the thick&#xD;
      haptics maybe an incomplete closure of the capsule at the optic rim with a reduced bending&#xD;
      effect of the posterior capsule around the posterior optic edge. Additionally, the posterior&#xD;
      sharp edge is often discontinuous in the region of the haptic-optic junctions. These&#xD;
      locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting in PCO.&#xD;
      Nowadays a multitude of different single piece IOLS are available, many of them similar but&#xD;
      of course with some differences in regard to the chemical composition of the acrylic material&#xD;
      and the IOL design.&#xD;
&#xD;
      The purpose of this study is to compare the intensity of posterior capsule opacification&#xD;
      (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs)&#xD;
      over a period of 3 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">May 2010</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Posterior Capsule Opacification (PCO)</measure>
    <time_frame>3 years</time_frame>
    <description>PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy</measure>
    <time_frame>3 years</time_frame>
    <description>Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Capsule Opacification</condition>
  <condition>Pseudophakia</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>iMics1 NY-60</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>eyes with implantation of iMics1 NY-60 IOL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AcrySof SN60WF</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>eyes with implantation of AcrySof SN60WF IOL</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intraocular lens implantation</intervention_name>
    <arm_group_label>AcrySof SN60WF</arm_group_label>
    <arm_group_label>iMics1 NY-60</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;
          -  history of ocular disease or intraocular surgery&#xD;
&#xD;
          -  laser treatment&#xD;
&#xD;
          -  diabetes requiring medical control&#xD;
&#xD;
          -  glaucoma&#xD;
&#xD;
          -  severe retinal pathology that would make a postoperative visual acuity of 20/40&#xD;
             (decimal equivalent = 0.5) or better unlikely&#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>Rupert Menapace, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>February 4, 2013</results_first_submitted>
  <results_first_submitted_qc>April 30, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 5, 2013</results_first_posted>
  <last_update_submitted>April 30, 2013</last_update_submitted>
  <last_update_submitted_qc>April 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 5, 2013</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>Prof. Dr. Rupert Menapace</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Capsule Opacification</mesh_term>
    <mesh_term>Pseudophakia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patients Included</title>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized</title>
              <participants_list>
                <participants group_id="P1" count="100">Randomized implantation SN60WF IOL in on eye and iMics NY-60 in the other eye.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Allocation</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>chronical illness</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cataract Surgery</title>
          <description>eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Posterior Capsule Opacification (PCO)</title>
        <description>PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>iMics1 NY-60</title>
            <description>eyes with implantation of iMics1 NY-60 IOL</description>
          </group>
          <group group_id="O2">
            <title>AcrySof SN60WF</title>
            <description>eyes with implantation of AcrySof SN60WF IOL</description>
          </group>
        </group_list>
        <measure>
          <title>Posterior Capsule Opacification (PCO)</title>
          <description>PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)</description>
          <units>units on a scale (0-10)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="2.0"/>
                    <measurement group_id="O2" value="1.9" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy</title>
        <description>Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>iMics1 NY-60</title>
            <description>eyes with implantation of iMics1 NY-60 IOL</description>
          </group>
          <group group_id="O2">
            <title>AcrySof SN60WF</title>
            <description>eyes with implantation of AcrySof SN60WF IOL</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy</title>
          <description>Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values</description>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="0"/>
                    <measurement group_id="O2" value="10" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>iMics1 NY-60</title>
          <description>eyes with implantation of iMics1 NY-60 IOL</description>
        </group>
        <group group_id="E2">
          <title>AcrySof SN60WF</title>
          <description>eyes with implantation of AcrySof SN60WF IOL</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Dr. R. Menapace</name_or_title>
      <organization>Medical University of Vienna</organization>
      <phone>+43 699 19660272</phone>
      <email>rupert.menapace@meduniwien.ac.at</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01732484
org study id: EK1444/2012
nct id: NCT01732484
lead sponsor: 
Age-related cataract is the main cause of impaired vision in the elderly population
      worldwide. In the UK, more than half of people who are over 65 have some cataract development
      in one or both eyes. 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. It is estimated that around 10 million cataract
      operations are performed around the world each year. Cataract operations are generally very
      successful, with a low risk of serious complications. The most common risk is developing a
      condition called posterior capsule opacification (PCO), which causes impaired vision to
      return.

      During the past two decades, cataract surgery underwent tremendous change and modernisation
      resulting in today's small incision phacoemulsification surgery and a safe technique with a
      short rehabilitation time for the patient. The most frequent long-term complication of
      cataract surgery remains to be posterior capsule opacification (PCO). In the past few years,
      refinements in surgical technique and modifications in IOL design and material have led to a
      decrease in the incidence of PCO.

      It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial
      cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule
      opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic
      towards the end of the production process, also called multipiece designs.

      For several reasons such as better ease of use with injector systems and higher efficiency in
      the production process, companies have developed IOLs with open-loop haptics out of one block
      of material, also called single-piece designs. In the case of such single-piece IOLs, the
      haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the thick
      haptics maybe an incomplete closure of the capsule at the optic rim with a reduced bending
      effect of the posterior capsule around the posterior optic edge. Additionally, the posterior
      sharp edge is often discontinuous in the region of the haptic-optic junctions. These
      locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting in PCO.
      Nowadays a multitude of different single piece 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 intensity of posterior capsule opacification
      (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs)
      over a period of 3 years.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Posterior Capsule Opacification (PCO)
time frame: 3 years
description: PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)
measure: Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy
time frame: 3 years
description: Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values
arm group label: iMics1 NY-60
arm group type: Other
description: eyes with implantation of iMics1 NY-60 IOL
arm group label: AcrySof SN60WF
arm group type: Other
description: eyes with implantation of AcrySof SN60WF IOL
intervention type: Procedure
intervention name: intraocular lens implantation
arm group label: AcrySof SN60WF
arm group label: iMics1 NY-60
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Rupert Menapace, MD
role: Principal Investigator
affiliation: Medical University Vienna
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Rupert Menapace
investigator title: Prof. Dr. Rupert Menapace
mesh term: Cataract
mesh term: Capsule Opacification
mesh term: Pseudophakia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 