<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/NCT03749798</url>
  </required_header>
  <id_info>
    <org_study_id>HeLeNa</org_study_id>
    <nct_id>NCT03749798</nct_id>
  </id_info>
  <brief_title>Comparing an Intraoperative vs. a Standard Wavefront Device</brief_title>
  <official_title>To Collect and Compare Data With an Intraoperative Wavefront Device (HeLeNa) to a Standard Wavefront Device: an Explorative Pilot Study</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>
      Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront&#xD;
      data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Different technologies are in use for measuring wavefront aberrations, such as Hartmann-Shack&#xD;
      wavefront aberrometry, Tscherning aberrometry, Laser Raytracing and automatic retinoscopy.&#xD;
      While Hartmann-Shack wavefront aberrometry, the most widespread of these techniques, uses a&#xD;
      lenslet array to record distortions of light bundles coming from a single source form the&#xD;
      retina, Tscherning aberrometry uses a matrix of pinholes. Laser Ray Tracing in contrast&#xD;
      measures the aberration of a laser beam at different locations. All three systems compare&#xD;
      distorsions of the measured light beams with a perfect optical system to calculate the&#xD;
      wavefront errors. Repeatability of wavefront devices was studied in young healthy subjects&#xD;
      and different devices have been compared to each other. These results do not represent the&#xD;
      typical cataract patient. Several factors, such as tear film instability and pupil size, have&#xD;
      an influence on the measurements and these factors may change significantly with age.&#xD;
&#xD;
      Intraoperative measured data could help to get a better information about wavefront&#xD;
      aberrations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wavefront aberration measurements</measure>
    <time_frame>12 months</time_frame>
    <description>Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Intraoperative wavefront measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be measured with an intraoperative wavefront device during cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cataract surgery</intervention_name>
    <description>Intraoperative wavefront measurements will be carried out during cataract surgery</description>
    <arm_group_label>Intraoperative wavefront measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cataract&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  Able to understand the patient information&#xD;
&#xD;
          -  Willing to follow the instructions and attend all follow-up visits&#xD;
&#xD;
          -  Willing to sign informed consent prior to surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Relevant other ophthalmic diseases that are likely to reduce the refractive outcome,&#xD;
             such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars&#xD;
&#xD;
          -  Previous ocular surgeries on the study eye&#xD;
&#xD;
          -  Patients who are not able to cooperate, with eccentric fixation or insufficient&#xD;
             ability to fixate (tremor, nystagmus)&#xD;
&#xD;
          -  Pregnant or lactating women (pregnancy testing will be performed preoperatively on&#xD;
             women of reproductive age)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Julius Hienert, MD</last_name>
    <phone>01 910 21-57564</phone>
    <email>office@viros.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nino Hirnschall, MD</last_name>
    <phone>01 910 21-57564</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>Julius Hienert, MD</last_name>
      <phone>01 910 21-57564</phone>
      <email>office@viros.at</email>
    </contact>
    <contact_backup>
      <last_name>Nino Hirnschall, MD</last_name>
      <phone>01 910 21-57564</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 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 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>Wavefront measurement</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/NCT03749798
org study id: HeLeNa
nct id: NCT03749798
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront
      data.
Different technologies are in use for measuring wavefront aberrations, such as Hartmann-Shack
      wavefront aberrometry, Tscherning aberrometry, Laser Raytracing and automatic retinoscopy.
      While Hartmann-Shack wavefront aberrometry, the most widespread of these techniques, uses a
      lenslet array to record distortions of light bundles coming from a single source form the
      retina, Tscherning aberrometry uses a matrix of pinholes. Laser Ray Tracing in contrast
      measures the aberration of a laser beam at different locations. All three systems compare
      distorsions of the measured light beams with a perfect optical system to calculate the
      wavefront errors. Repeatability of wavefront devices was studied in young healthy subjects
      and different devices have been compared to each other. These results do not represent the
      typical cataract patient. Several factors, such as tear film instability and pupil size, have
      an influence on the measurements and these factors may change significantly with age.

      Intraoperative measured data could help to get a better information about wavefront
      aberrations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Wavefront aberration measurements
time frame: 12 months
description: Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative).
arm group label: Intraoperative wavefront measurement
arm group type: Experimental
description: Patients will be measured with an intraoperative wavefront device during cataract surgery
intervention type: Procedure
intervention name: Cataract surgery
description: Intraoperative wavefront measurements will be carried out during cataract surgery
arm group label: Intraoperative wavefront measurement
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 105 Years
healthy volunteers: No
last name: Julius Hienert, MD
phone: 01 910 21-57564
email: office@viros.at
last name: Nino Hirnschall, MD
phone: 01 910 21-57564
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