<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/NCT01663597</url>
  </required_header>
  <id_info>
    <org_study_id>OPHTH-240512</org_study_id>
    <nct_id>NCT01663597</nct_id>
  </id_info>
  <brief_title>Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes</brief_title>
  <official_title>Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes</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>
      Aberrations play a significant role in the visual process and can be divided in lower-order&#xD;
      and higher-order aberrations. The former can be measured using the commercially available IOL&#xD;
      Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity.&#xD;
      Higher-order aberrations do not significantly influence visual acuity but affect the quality&#xD;
      of vision and can cause halos, double vision, and night vision disturbances.&#xD;
&#xD;
      Background Cataract surgery has become a routine procedure in the developed countries. During&#xD;
      this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However,&#xD;
      these lenses do not account for individual optical biometry data or aberrations. Therefore,&#xD;
      it is important to provide data for ametropic and emmetropic eyes as this information might&#xD;
      improve future intraocular lens design and lead to individually adapted lenses for yielding&#xD;
      optimal visual acuity and quality results.&#xD;
&#xD;
      The aim of the present study is to clarify the correlation between refractive errors/axial&#xD;
      eye length and spherical aberrations of the cornea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Axial eye length</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Refractive error</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal radius</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pupil diameter</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior chamber depth</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior corneal topography</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal thickness map</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Refractive Errors</condition>
  <condition>Axial Length, Eye</condition>
  <condition>Corneal Wavefront Aberration</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>40 subjects with high grarde myopia ranging from -10 diopters to -4.01 diopters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>40 subjects with moderate myopia ranging from -4 diopters to -1.01 diopter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <description>40 subjects with emmetropia, -1 diopter to +1 diopter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <description>40 subjects with hyperopia, +1.01 diopter and more</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The participants will be selected by the Department of Clinical Pharmacology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women aged between 40 and 60 years&#xD;
&#xD;
          -  normal findings in the medical history unless the investigator considers an&#xD;
             abnormality to be clinically irrelevant&#xD;
&#xD;
          -  normal ophthalmic findings unless the investigator considers an abnormality to be&#xD;
             clinically irrelevant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of any corneal or retinal disease&#xD;
&#xD;
          -  Dry eye syndrome&#xD;
&#xD;
          -  high astigmatism (&gt;1 diopter)&#xD;
&#xD;
          -  history of refractive surgery&#xD;
&#xD;
          -  abuse of alcoholic beverages&#xD;
&#xD;
          -  participation in a clinical trial in the 3 weeks preceding the study&#xD;
&#xD;
          -  symptoms of a clinically relevant illness in the 3 weeks before the study day&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>August 28, 2013</last_update_submitted>
  <last_update_submitted_qc>August 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 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>Gerhard Garhofer</investigator_full_name>
    <investigator_title>Assoc. Prof. Priv. Doz. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Refractive Errors</mesh_term>
    <mesh_term>Corneal Wavefront Aberration</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/NCT01663597
org study id: OPHTH-240512
nct id: NCT01663597
lead sponsor: 
Aberrations play a significant role in the visual process and can be divided in lower-order
      and higher-order aberrations. The former can be measured using the commercially available IOL
      Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity.
      Higher-order aberrations do not significantly influence visual acuity but affect the quality
      of vision and can cause halos, double vision, and night vision disturbances.

      Background Cataract surgery has become a routine procedure in the developed countries. During
      this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However,
      these lenses do not account for individual optical biometry data or aberrations. Therefore,
      it is important to provide data for ametropic and emmetropic eyes as this information might
      improve future intraocular lens design and lead to individually adapted lenses for yielding
      optimal visual acuity and quality results.

      The aim of the present study is to clarify the correlation between refractive errors/axial
      eye length and spherical aberrations of the cornea.
observational model: Cohort
time perspective: Prospective
measure: Axial eye length
time frame: 1 day
measure: Refractive error
time frame: 1 day
measure: Corneal radius
time frame: 1 day
measure: Pupil diameter
time frame: 1 day
measure: Anterior chamber depth
time frame: 1 day
measure: Anterior corneal topography
time frame: 1 day
measure: Corneal thickness map
time frame: 1 day
arm group label: Cohort 1
description: 40 subjects with high grarde myopia ranging from -10 diopters to -4.01 diopters
arm group label: Cohort 2
description: 40 subjects with moderate myopia ranging from -4 diopters to -1.01 diopter
arm group label: Cohort 3
description: 40 subjects with emmetropia, -1 diopter to +1 diopter
arm group label: Cohort 4
description: 40 subjects with hyperopia, +1.01 diopter and more
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Gerhard Garhofer
investigator title: Assoc. Prof. Priv. Doz. Dr.
mesh term: Refractive Errors
mesh term: Corneal Wavefront Aberration