<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/NCT03751462</url>
  </required_header>
  <id_info>
    <org_study_id>Pseudophakodonesis</org_study_id>
    <nct_id>NCT03751462</nct_id>
  </id_info>
  <brief_title>Prediction of Pseudophakodonesis of Intraocular Lenses</brief_title>
  <official_title>Prediction of Pseudophakodonesis After Uneventful Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Prof. Dr. Oliver Findl, MBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vienna Institute for Research in Ocular Surgery</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>
      Compare visual acuity of patients after cataract surgery with implantation of an IOL clinical&#xD;
      outcome measure in eyes with and without pseudoexfoliation syndrome or history of ocular&#xD;
      trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cataract surgery ist the most often performed surgery worldwide and with increasing number of&#xD;
      patients undergoing surgery, patients' expectations concerning postoperative optical outcomes&#xD;
      are growing. In order to achieve an optimal outcome after cataract surgery an adequate&#xD;
      intraocular lens (IOL) centration is essential, especially when premium IOLs like aspheric,&#xD;
      toric or multifocal IOls are being implanted. This fact has to be kept in mind especially in&#xD;
      patients with pseudoexfoliation syndrome (PXF) or with history of blunt ocular trauma, where&#xD;
      decentration and subluxation of the IOL is more likely due to a higher incidence of zonular&#xD;
      weakness and zonular dialysis.&#xD;
&#xD;
      Additionally, pseudophacodonesis - dangling of the IOL with eye movement - can occur.&#xD;
      Decentration, tilt and dangling of the IOL may decrease visual acuity and contrast&#xD;
      sensitivity and induce glare and subjective perception of image flickering. Because of the&#xD;
      large amount of pseudophakic patients worldwide, decentered and dislocated IOLs may cause a&#xD;
      relatively large public health care burden.&#xD;
&#xD;
      Additionally, IOL implantation in eyes with zonular pathology may be technically challenging.&#xD;
      Several devices to improve IOL stability in demanding eyes have been developed and may be&#xD;
      used in cases lacking sufficient zonular support, such as different capsular tension rings.&#xD;
      Another option would be to use special surgical techniques like scleral fixation of the IOL.&#xD;
&#xD;
      In pseudophakic eyes, IOL tilt and decentration may be measured as an indicator for zonular&#xD;
      stability. Several techniques have been used to measure IOL decentration and tilt, such as&#xD;
      slitlamp examination, retroillumination photography, Scheimpflug imaging and the analysis of&#xD;
      purkinje reflexes. Slitlamp examination is a subjective method that allows approximate&#xD;
      decentration measurements, but no quantitative tilt measurements. For this measurement the&#xD;
      pupil has to be dilated. Scheimpflug imaging also needs a sufficiently dilated pupil to make&#xD;
      the optic edge and the posterior surface of the IOL visible. A recently developed purkinje&#xD;
      meter was shown to be highly reproducible to assess IOL tilt and decentration. A new version&#xD;
      of this purkinje meter can additionally acquire videos of eye movements. Analysis of these&#xD;
      dynamic images can detect dangling or &quot;wobbling&quot; of the lens capsule and the IOL.&#xD;
&#xD;
      Patients within this study will be examined on two occasions. Only one additional visit will&#xD;
      be necessary as the first examination will take place on the day of the routine pre-operative&#xD;
      visit and all measurements will be non invasive. The results will lead to a better&#xD;
      understanding of the long-term outcome after implanting IOLs in eyes with pseudoexfoliation&#xD;
      syndrome or a ocular trauma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>IOL wobble</measure>
    <time_frame>12 months</time_frame>
    <description>IOL wobble, tilt and decentration will be assessed in patients with PEX or traumatic cataract using the Purkinjemeter device. The smaller the amount of IOL wobble, tilt and decentration, the better the results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected distance visual acuity (BCDVA)</measure>
    <time_frame>12 months</time_frame>
    <description>BCDVA will be assessed using a ETDRS chart in 4 meters distance. The more words the patient can read, the better the outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Pseudoexfoliation syndrome</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with pseudoexfoliation syndrome or traumatic cataract will be examined using the Purkinjemeter device concerning IOL wobble, tilt and decentration</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Purkinjemeter</intervention_name>
    <description>The Purkinjemeter will be used for assessment of IOL wobbling, tilt and decentration in patients with pseudoexfoliation syndrome or traumatic cataract</description>
    <arm_group_label>Pseudoexfoliation syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cataract with the indication for surgery (decrease in visual acuity, blurred vision or&#xD;
             glare ) for both groups (study and control group)&#xD;
&#xD;
          -  Age 18 and older&#xD;
&#xD;
          -  Normal findings in the medical history and physical examination unless the&#xD;
             investigator considers an abnormality to be clinically irrelevant&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Pseudoexfoliation syndrome or history of blunt ocular trauma - for the study group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pseudoexfoliation syndrome or history of blunt ocular trauma - for the control group&#xD;
&#xD;
          -  History of penetrating ocular trauma&#xD;
&#xD;
          -  Relevant other ophthalmic diseases that could affect corneal transparency or the&#xD;
             ability for fixation&#xD;
&#xD;
          -  Any relevant ophthalmic disease leading to limited visual acuity prognosis after&#xD;
             cataract surgery&#xD;
&#xD;
          -  In case of pregnancy (pregnancy test will be taken preoperatively in women of&#xD;
             reproductive age)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sophie Mädel, MD</last_name>
    <phone>01 91021-57564</phone>
    <email>office@viros.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nino Hirnschall, MD</last_name>
    <phone>01 91021-57564</phone>
    <email>office@viros.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vienna Institute for Research in Ocular Surgery (VIROS)</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie Mädel, MD</last_name>
      <phone>01 91021-57564</phone>
      <email>office@viros.at</email>
    </contact>
    <contact_backup>
      <last_name>Nino Hirnschall, MD</last_name>
      <phone>01 91021-57564</phone>
      <email>office@viros.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vienna Institute for Research in Ocular Surgery</investigator_affiliation>
    <investigator_full_name>Prim. Prof. Dr. Oliver Findl, MBA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cataract</keyword>
  <keyword>Pseudoexfoliation</keyword>
  <keyword>Traumatic cataract</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03751462
org study id: Pseudophakodonesis
nct id: NCT03751462
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Compare visual acuity of patients after cataract surgery with implantation of an IOL clinical
      outcome measure in eyes with and without pseudoexfoliation syndrome or history of ocular
      trauma.
Cataract surgery ist the most often performed surgery worldwide and with increasing number of
      patients undergoing surgery, patients' expectations concerning postoperative optical outcomes
      are growing. In order to achieve an optimal outcome after cataract surgery an adequate
      intraocular lens (IOL) centration is essential, especially when premium IOLs like aspheric,
      toric or multifocal IOls are being implanted. This fact has to be kept in mind especially in
      patients with pseudoexfoliation syndrome (PXF) or with history of blunt ocular trauma, where
      decentration and subluxation of the IOL is more likely due to a higher incidence of zonular
      weakness and zonular dialysis.

      Additionally, pseudophacodonesis - dangling of the IOL with eye movement - can occur.
      Decentration, tilt and dangling of the IOL may decrease visual acuity and contrast
      sensitivity and induce glare and subjective perception of image flickering. Because of the
      large amount of pseudophakic patients worldwide, decentered and dislocated IOLs may cause a
      relatively large public health care burden.

      Additionally, IOL implantation in eyes with zonular pathology may be technically challenging.
      Several devices to improve IOL stability in demanding eyes have been developed and may be
      used in cases lacking sufficient zonular support, such as different capsular tension rings.
      Another option would be to use special surgical techniques like scleral fixation of the IOL.

      In pseudophakic eyes, IOL tilt and decentration may be measured as an indicator for zonular
      stability. Several techniques have been used to measure IOL decentration and tilt, such as
      slitlamp examination, retroillumination photography, Scheimpflug imaging and the analysis of
      purkinje reflexes. Slitlamp examination is a subjective method that allows approximate
      decentration measurements, but no quantitative tilt measurements. For this measurement the
      pupil has to be dilated. Scheimpflug imaging also needs a sufficiently dilated pupil to make
      the optic edge and the posterior surface of the IOL visible. A recently developed purkinje
      meter was shown to be highly reproducible to assess IOL tilt and decentration. A new version
      of this purkinje meter can additionally acquire videos of eye movements. Analysis of these
      dynamic images can detect dangling or "wobbling" of the lens capsule and the IOL.

      Patients within this study will be examined on two occasions. Only one additional visit will
      be necessary as the first examination will take place on the day of the routine pre-operative
      visit and all measurements will be non invasive. The results will lead to a better
      understanding of the long-term outcome after implanting IOLs in eyes with pseudoexfoliation
      syndrome or a ocular trauma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: IOL wobble
time frame: 12 months
description: IOL wobble, tilt and decentration will be assessed in patients with PEX or traumatic cataract using the Purkinjemeter device. The smaller the amount of IOL wobble, tilt and decentration, the better the results.
measure: Best corrected distance visual acuity (BCDVA)
time frame: 12 months
description: BCDVA will be assessed using a ETDRS chart in 4 meters distance. The more words the patient can read, the better the outcome.
arm group label: Pseudoexfoliation syndrome
arm group type: Experimental
description: Patients with pseudoexfoliation syndrome or traumatic cataract will be examined using the Purkinjemeter device concerning IOL wobble, tilt and decentration
intervention type: Device
intervention name: Purkinjemeter
description: The Purkinjemeter will be used for assessment of IOL wobbling, tilt and decentration in patients with pseudoexfoliation syndrome or traumatic cataract
arm group label: Pseudoexfoliation syndrome
criteria: 
gender: All
minimum age: 21 Years
maximum age: 105 Years
healthy volunteers: No
last name: Sophie Mädel, MD
phone: 01 91021-57564
email: office@viros.at
last name: Nino Hirnschall, MD
phone: 01 91021-57564
email: office@viros.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Vienna Institute for Research in Ocular Surgery
investigator full name: Prim. Prof. Dr. Oliver Findl, MBA
investigator title: Principal Investigator
mesh term: Cataract
sharing ipd: Undecided