<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/NCT03297086</url>
  </required_header>
  <id_info>
    <org_study_id>Kappa1</org_study_id>
    <nct_id>NCT03297086</nct_id>
  </id_info>
  <brief_title>Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses</brief_title>
  <official_title>Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medicontur Kft</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Semmelweis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate possible changes of angle kappa after multifocal&#xD;
      intraocular lens implantation. Presumable influencing factors of postoperative visual axis&#xD;
      shift (ie. biometric parameters of the eye) are investigated to determine the degree and&#xD;
      direction of angle kappa alterations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate changes of angle kappa after multifocal intraocular&#xD;
      lens implantation.&#xD;
&#xD;
      During cataract surgery Medicontur Bi-Flex 677MY IOL and Alcon Acrysof Restor SN6AD1 IOL are&#xD;
      implanted. Optical biometry is carried out for IOL calculation and to measure axial length&#xD;
      and angle kappa. Three months after surgery biometry is repeated, IOL position and angle&#xD;
      kappa are measured using Scheimpflug-camera.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2015</start_date>
  <completion_date type="Actual">September 11, 2017</completion_date>
  <primary_completion_date type="Actual">February 25, 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of changes of angle kappa after multifocal intraocular lens implantation.</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in magnitude and orientation of angle kappa (deviation between the visual and pupillary axis) are measured before and after cataract surgery with multifoocal intraocular lens implantation. During pre-and postoperative examination optical biometry is carried out using Lenstar LS 900. Optical biometer determines deviation between the visual and pupillary axis that represents angle kappa. Deviation of these axes can be defined by its magnitude and orientation. Location of the pupil centre relative to the visual axis - the reference axis - is determined by x- and y-offsets using trigonometrical analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of influencing effect of biometrical data on postoperative visual axis shift</measure>
    <time_frame>3 months</time_frame>
    <description>Biometry data (axial length, keratometry, lens thickness, anterior chamber depth) are measured preoperatively by Lenstar LS 900 optical biometer. Their effect on changes of angle kappa is determined using statistical analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of influencing effect of intraocular lens decentration on postoperative visual axis shift</measure>
    <time_frame>3 months</time_frame>
    <description>Three months after cataract surgery postoperative intraocular lens (IOL) position is determined using a rotating Scheimpflug-camera (Galilei G4). IOL decentration is obtained from the distance between the IOL centre and visual axis. The effect of possible IOL decentration on changes of angle kappa is determined using statistical analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Cataract</condition>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Bi-Flex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medicontur Bi-Flex 677MY IOL was implanted into 24 eyes of 12 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ReStor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>and Alcon Acrysof Restor SN6AD1 IOL was implanted into 36 eyes of 18 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cataract surgery</intervention_name>
    <description>cataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens</description>
    <arm_group_label>Bi-Flex</arm_group_label>
    <arm_group_label>ReStor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with age related cataract and presbyopia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous ocular surgery, trauma, active ocular disease, poorly dilated&#xD;
             pupils, or known zonular weakness and corneal astigmatism &gt;1.5 diopters were excluded&#xD;
             from the study.&#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>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multifocal intraocular lens, angle kappa, presbyopia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Presbyopia</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/NCT03297086
org study id: Kappa1
nct id: NCT03297086
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
The purpose of this study is to evaluate possible changes of angle kappa after multifocal
      intraocular lens implantation. Presumable influencing factors of postoperative visual axis
      shift (ie. biometric parameters of the eye) are investigated to determine the degree and
      direction of angle kappa alterations.
The purpose of this study is to evaluate changes of angle kappa after multifocal intraocular
      lens implantation.

      During cataract surgery Medicontur Bi-Flex 677MY IOL and Alcon Acrysof Restor SN6AD1 IOL are
      implanted. Optical biometry is carried out for IOL calculation and to measure axial length
      and angle kappa. Three months after surgery biometry is repeated, IOL position and angle
      kappa are measured using Scheimpflug-camera.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Measurement of changes of angle kappa after multifocal intraocular lens implantation.
time frame: 3 months
description: Changes in magnitude and orientation of angle kappa (deviation between the visual and pupillary axis) are measured before and after cataract surgery with multifoocal intraocular lens implantation. During pre-and postoperative examination optical biometry is carried out using Lenstar LS 900. Optical biometer determines deviation between the visual and pupillary axis that represents angle kappa. Deviation of these axes can be defined by its magnitude and orientation. Location of the pupil centre relative to the visual axis - the reference axis - is determined by x- and y-offsets using trigonometrical analysis.
measure: Determination of influencing effect of biometrical data on postoperative visual axis shift
time frame: 3 months
description: Biometry data (axial length, keratometry, lens thickness, anterior chamber depth) are measured preoperatively by Lenstar LS 900 optical biometer. Their effect on changes of angle kappa is determined using statistical analysis.
measure: Determination of influencing effect of intraocular lens decentration on postoperative visual axis shift
time frame: 3 months
description: Three months after cataract surgery postoperative intraocular lens (IOL) position is determined using a rotating Scheimpflug-camera (Galilei G4). IOL decentration is obtained from the distance between the IOL centre and visual axis. The effect of possible IOL decentration on changes of angle kappa is determined using statistical analysis.
arm group label: Bi-Flex
arm group type: Active Comparator
description: Medicontur Bi-Flex 677MY IOL was implanted into 24 eyes of 12 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured.
arm group label: ReStor
arm group type: Active Comparator
description: and Alcon Acrysof Restor SN6AD1 IOL was implanted into 36 eyes of 18 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured.
intervention type: Procedure
intervention name: cataract surgery
description: cataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens
arm group label: Bi-Flex
arm group label: ReStor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cataract
mesh term: Presbyopia