<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/NCT02228109</url>
  </required_header>
  <id_info>
    <org_study_id>20067</org_study_id>
    <nct_id>NCT02228109</nct_id>
  </id_info>
  <brief_title>Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population</brief_title>
  <acronym>BUICK</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johnson &amp; Johnson Vision Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Waterloo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to use a corneal topographer, a device that is readily available&#xD;
      in most optometric practices, in order to determine the position of the multifocal (MF)&#xD;
      contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this&#xD;
      study is to evaluate if there is a relationship between the positioning of the optics of the&#xD;
      study lenses and the objective and subjective visual performance as well as participant&#xD;
      satisfaction. The MF CL lenses will be fitted to two groups of participants (previously&#xD;
      unsuccessful vs. currently successful MF CL wearers).&#xD;
&#xD;
      HYPOTHESES&#xD;
&#xD;
        -  The measurement of the power distribution acquired from the Medmont E300 corneal&#xD;
           topographer is effective in determining MF CL lens centration and is a predictor of MF&#xD;
           CL success.&#xD;
&#xD;
        -  There is a difference in MF CL centration, determined by corneal topography, between&#xD;
           successful and unsuccessful MF CL wearers.&#xD;
&#xD;
        -  MF CL centration, determined by corneal topography, is correlated with visual&#xD;
           performance, determined by ocular aberrometry, measures of visual acuity and subjective&#xD;
           satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decentration</measure>
    <time_frame>Day 1</time_frame>
    <description>Decentration (in mm and axis of decentration) of the multifocal contact lens optical center relative to ocular reference points (e.g. the pupil center or the line of sight), determined using difference maps produced by the Medmont E300 corneal topographer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity (high contrast) at distance</measure>
    <time_frame>Day 1</time_frame>
    <description>Visual Acuity (high contrast) (logMAR) at distance 6m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity (high contrast) at intermediate distance</measure>
    <time_frame>Day 1</time_frame>
    <description>Visual Acuity (high contrast) (logMAR) at intermediate distance 1m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity (high contrast) at near</measure>
    <time_frame>Day 1</time_frame>
    <description>Visual Acuity (high contrast) (logMAR) at near (0.4m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity (low contrast) at distance</measure>
    <time_frame>Day 1</time_frame>
    <description>Visual Acuity (low contrast) at distance 6m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity (low contrast) at intermediate distance</measure>
    <time_frame>Day 1</time_frame>
    <description>Visual Acuity (low contrast) (logMAR) at intermediate distance 1m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity (low contrast) at near</measure>
    <time_frame>Day 1</time_frame>
    <description>Visual Acuity (low contrast) (logMAR) at near (0.4m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall subjective rating of lens performance in real world tasks</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants rate overall satisfaction with vision with the contact lenses on a scale of 0-100, where 0=completely dissatisfied and 100=completely satisfied, after completing a series of real world tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular aberrometry</measure>
    <time_frame>Day 1</time_frame>
    <description>Ocular aberrometry as measured by a LADARWave aberrometer</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Acuvue Oasys for Presbyopia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acuvue Oasys for Presbyopia contact lenses worn</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PureVision2 for Presbyopia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PureVision2 for Presbyopia contact lenses worn</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofinity Multifocal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biofinity Multifocal contact lenses worn</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acuvue Oasys for Presbyopia</intervention_name>
    <description>Acuvue Oasys for Presbyopia contact lenses worn</description>
    <arm_group_label>Acuvue Oasys for Presbyopia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PureVision2 for Presbyopia</intervention_name>
    <description>PureVision2 for Presbyopia contact lenses worn</description>
    <arm_group_label>PureVision2 for Presbyopia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofinity Multifocal</intervention_name>
    <description>Biofinity Multifocal contact lenses worn</description>
    <arm_group_label>Biofinity Multifocal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A person is eligible for inclusion in the study if he/she:&#xD;
&#xD;
          1. Is at least 42 years of age and has full legal capacity to volunteer;&#xD;
&#xD;
          2. Has read and signed an information consent letter;&#xD;
&#xD;
          3. Is willing and able to follow instructions and maintain the appointment schedule;&#xD;
&#xD;
          4. Has previous experience with wearing MF CLs;&#xD;
&#xD;
          5. Is able to be successfully fitted with all study lenses;&#xD;
&#xD;
          6. Has a vertex-corrected spherical distance prescription of +6.00 to 8.00D (inclusive)&#xD;
             in both eyes;&#xD;
&#xD;
          7. Has a spectacle cylinder ≤0.75D in both eyes;&#xD;
&#xD;
          8. Requires a reading addition of ≥+1.00D;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A person will be excluded from the study if he/she:&#xD;
&#xD;
          1. Is participating in any concurrent clinical or research study;&#xD;
&#xD;
          2. Has any known active* ocular disease and/or infection;&#xD;
&#xD;
          3. Has a systemic condition that in the opinion of the investigator may affect a study&#xD;
             outcome variable;&#xD;
&#xD;
          4. Is using any systemic or topical medications that in the opinion of the investigator&#xD;
             may affect a study outcome variable;&#xD;
&#xD;
          5. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;&#xD;
&#xD;
          6. Is pregnant, lactating or planning a pregnancy at the time of enrolment;&#xD;
&#xD;
          7. Is aphakic;&#xD;
&#xD;
          8. Has undergone refractive error surgery;&#xD;
&#xD;
          9. Has monocular best-corrected VA of worse than 20/30 in each eye;&#xD;
&#xD;
         10. Has amblyopia or strabismus;&#xD;
&#xD;
         11. Has anisometropia &gt;2D between both eyes&#xD;
&#xD;
               -  For the purposes of this study, active ocular disease is defined as infection or&#xD;
                  inflammation which requires therapeutic treatment. Mild (i.e. not considered&#xD;
                  clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction,&#xD;
                  papillae), corneal and conjunctival staining and dry eye are not considered&#xD;
                  active ocular disease. Neovascularization and corneal scars are the result of&#xD;
                  previous hypoxia, infection or inflammation and are therefore not active.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyndon Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CCLR, University of Waterloo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Contact Lens Research, University of Waterloo</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02228109
org study id: 20067
nct id: NCT02228109
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to use a corneal topographer, a device that is readily available
      in most optometric practices, in order to determine the position of the multifocal (MF)
      contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this
      study is to evaluate if there is a relationship between the positioning of the optics of the
      study lenses and the objective and subjective visual performance as well as participant
      satisfaction. The MF CL lenses will be fitted to two groups of participants (previously
      unsuccessful vs. currently successful MF CL wearers).

      HYPOTHESES

        -  The measurement of the power distribution acquired from the Medmont E300 corneal
           topographer is effective in determining MF CL lens centration and is a predictor of MF
           CL success.

        -  There is a difference in MF CL centration, determined by corneal topography, between
           successful and unsuccessful MF CL wearers.

        -  MF CL centration, determined by corneal topography, is correlated with visual
           performance, determined by ocular aberrometry, measures of visual acuity and subjective
           satisfaction.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Decentration
time frame: Day 1
description: Decentration (in mm and axis of decentration) of the multifocal contact lens optical center relative to ocular reference points (e.g. the pupil center or the line of sight), determined using difference maps produced by the Medmont E300 corneal topographer.
measure: Visual Acuity (high contrast) at distance
time frame: Day 1
description: Visual Acuity (high contrast) (logMAR) at distance 6m
measure: Visual Acuity (high contrast) at intermediate distance
time frame: Day 1
description: Visual Acuity (high contrast) (logMAR) at intermediate distance 1m
measure: Visual Acuity (high contrast) at near
time frame: Day 1
description: Visual Acuity (high contrast) (logMAR) at near (0.4m)
measure: Visual Acuity (low contrast) at distance
time frame: Day 1
description: Visual Acuity (low contrast) at distance 6m
measure: Visual Acuity (low contrast) at intermediate distance
time frame: Day 1
description: Visual Acuity (low contrast) (logMAR) at intermediate distance 1m
measure: Visual Acuity (low contrast) at near
time frame: Day 1
description: Visual Acuity (low contrast) (logMAR) at near (0.4m)
measure: Overall subjective rating of lens performance in real world tasks
time frame: Day 1
description: Participants rate overall satisfaction with vision with the contact lenses on a scale of 0-100, where 0=completely dissatisfied and 100=completely satisfied, after completing a series of real world tasks.
measure: Ocular aberrometry
time frame: Day 1
description: Ocular aberrometry as measured by a LADARWave aberrometer
arm group label: Acuvue Oasys for Presbyopia
arm group type: Experimental
description: Acuvue Oasys for Presbyopia contact lenses worn
arm group label: PureVision2 for Presbyopia
arm group type: Experimental
description: PureVision2 for Presbyopia contact lenses worn
arm group label: Biofinity Multifocal
arm group type: Experimental
description: Biofinity Multifocal contact lenses worn
intervention type: Device
intervention name: Acuvue Oasys for Presbyopia
description: Acuvue Oasys for Presbyopia contact lenses worn
arm group label: Acuvue Oasys for Presbyopia
intervention type: Device
intervention name: PureVision2 for Presbyopia
description: PureVision2 for Presbyopia contact lenses worn
arm group label: PureVision2 for Presbyopia
intervention type: Device
intervention name: Biofinity Multifocal
description: Biofinity Multifocal contact lenses worn
arm group label: Biofinity Multifocal
criteria: 
gender: All
minimum age: 42 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lyndon Jones, PhD
role: Principal Investigator
affiliation: CCLR, University of Waterloo
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Presbyopia