<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/NCT01729962</url>
  </required_header>
  <id_info>
    <org_study_id>AL-3</org_study_id>
    <nct_id>NCT01729962</nct_id>
  </id_info>
  <brief_title>Comparative Study of the Optical Biometer for Measurements of the Eye</brief_title>
  <official_title>Comparative Study of the Optical Biometer for the Measurements of Axial Length, Anterior Chamber Depth, Keratometry, Corneal Cylinder Axis, Corneal Thickness, White-to-White Distance, and Pupil Diameter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nidek Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nidek Co. LTD.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this comparative clinical study is to collect clinical data to&#xD;
      demonstrate the equivalence of the investigational device to the predicate device for&#xD;
      measurements of the eye. The secondary purpose is to evaluate any adverse events that occur&#xD;
      during the clinical study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective clinical study to be conducted at a single clinical site located in the&#xD;
      United States. This study will assess the agreement of an investigational device to the&#xD;
      predicate device and an ultrasound reference device and the precision of the investigational&#xD;
      device with a comparison to the precision of the predicate. Any adverse events associated&#xD;
      with the investigational device can or the predicate device will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement and Precision Endpoints Analyses</measure>
    <time_frame>Subjects will be followed for the duration of the procedure, up to one day.</time_frame>
    <description>The agreement of the Nidek optical biometer with the predicate device will be assessed for the following measures:&#xD;
Axial Length;&#xD;
Keratometry;&#xD;
Corneal Cylinder Axis;&#xD;
Anterior Chamber Depth;&#xD;
Central Corneal Thickness;&#xD;
White-to-White Distance; and&#xD;
Pupil Diameter.&#xD;
In addition, the agreement of the Nidek optical biometer with the ultrasound reference device will be assessed for axial length and anterior chamber depth.&#xD;
The precision of Nidek optical biometer and the predicate device will be assessed for the following measures:&#xD;
Axial Length;&#xD;
Keratometry;&#xD;
Corneal Cylinder Axis;&#xD;
Anterior Chamber Depth;&#xD;
Central Corneal Thickness;&#xD;
White-to-White Distance; and&#xD;
Pupil Diameter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Adverse Events Found During the Study</measure>
    <time_frame>Subjects will be followed for the duration of the procedure, up to one day.</time_frame>
    <description>The safety endpoint is to evaluate any adverse events associated with the Nidek optical biometer or the predicate or reference devices.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Additional Analyses for the Agreement Portion of the Study</measure>
    <time_frame>Subjects will be followed for the duration of the procedure, up to one day.</time_frame>
    <description>Additional analyses will examine the intraocular lens (IOL) power calculation from the Nidek optical biometer only based on the subjects enrolled in the agreement portion of the study.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">125</enrollment>
  <condition>Normal Non-fluency</condition>
  <condition>Cataract</condition>
  <condition>Aphakic Eye</condition>
  <condition>Eyes With Corneal Abnormality</condition>
  <arm_group>
    <arm_group_label>Agreement Cohort</arm_group_label>
    <description>All subjects in the agreement portion of the study will have a single measurement performed with each device, the Nidek optical biometer, predicate device and ultrasound reference device. Each device will be operated by a different operator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Precision Cohort</arm_group_label>
    <description>All subjects in the precision portion of the study will each be paired with one Nidek optical biometer and with one predicate device for a total of three Nidek optical biometer/predicate device pairs. Each of the three device pairs will be designated one and only one operator. All subjects in the precision portion of the study will have their measurements repeated three times on each of three Nidek optical biometer and predicate device pairs.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Normal eyes(phakic eyes without cataracts or corneal disease), eyes with cataracts, eyes&#xD;
        without a natural lens (including aphakic and pseudophakic eyes), eyes with corneal disease&#xD;
        (including eyes post keratorefractive surgery).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who can follow the instructions by the Principal/Clinical Investigator or&#xD;
             clinical staff at the clinical site, and can visit on scheduled examination dates.&#xD;
&#xD;
          2. Subjects who sign an informed consent form to participate in the clinical trial.&#xD;
&#xD;
          3. Subjects who agree to take the qualifying eye examination and a series of devices&#xD;
             measurements.&#xD;
&#xD;
          4. Subjects able to fixate on a target.&#xD;
&#xD;
          5. Subjects must meet at lease one of the following criteria:&#xD;
&#xD;
               -  Normal eyes: Subjects with a natural lens without a cataract, corneal&#xD;
                  abnormalities or prior keratorefractive surgery.&#xD;
&#xD;
               -  Eyes with Cataracts: Subjects with a pre-existing cataract without corneal&#xD;
                  abnormalities or prior keratorefractive surgery.&#xD;
&#xD;
               -  Eyes without a Natural Lens: Subjects that are pseudophakic or aphakic without&#xD;
                  corneal abnormalities or prior keratorefractive surgery.&#xD;
&#xD;
               -  Eyes with Corneal Abnormality: Subjects with a corneal abnormality and a natural&#xD;
                  lens without a cataract, or Subjects post keratorefractive surgery and a natural&#xD;
                  lens without a cataract.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Any eye condition preventing use of any of the instruments used in the study.&#xD;
&#xD;
          3. Any eye condition which might impair the validity of results from any of the&#xD;
             instruments used in the study.&#xD;
&#xD;
          4. Any medical condition, which, in the Investigator's judgment, interferes with the&#xD;
             subject's ability to comply with the protocol, compromises subject safety, or&#xD;
             interferes with the interpretation of the study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karl G Stonecipher, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physicians Protocol</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physicians Protocol</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27410-2548</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>June 26, 2013</last_update_submitted>
  <last_update_submitted_qc>June 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 28, 2013</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>Cataract</mesh_term>
    <mesh_term>Aphakia</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/NCT01729962
org study id: AL-3
nct id: NCT01729962
lead sponsor: 
has dmc: No
The primary purpose of this comparative clinical study is to collect clinical data to
      demonstrate the equivalence of the investigational device to the predicate device for
      measurements of the eye. The secondary purpose is to evaluate any adverse events that occur
      during the clinical study.
This is a prospective clinical study to be conducted at a single clinical site located in the
      United States. This study will assess the agreement of an investigational device to the
      predicate device and an ultrasound reference device and the precision of the investigational
      device with a comparison to the precision of the predicate. Any adverse events associated
      with the investigational device can or the predicate device will be assessed.
observational model: Case-Only
time perspective: Prospective
measure: Agreement and Precision Endpoints Analyses
time frame: Subjects will be followed for the duration of the procedure, up to one day.
description: The agreement of the Nidek optical biometer with the predicate device will be assessed for the following measures:
Axial Length;
Keratometry;
Corneal Cylinder Axis;
Anterior Chamber Depth;
Central Corneal Thickness;
White-to-White Distance; and
Pupil Diameter.
In addition, the agreement of the Nidek optical biometer with the ultrasound reference device will be assessed for axial length and anterior chamber depth.
The precision of Nidek optical biometer and the predicate device will be assessed for the following measures:
Axial Length;
Keratometry;
Corneal Cylinder Axis;
Anterior Chamber Depth;
Central Corneal Thickness;
White-to-White Distance; and
Pupil Diameter.
measure: Evaluation of Adverse Events Found During the Study
time frame: Subjects will be followed for the duration of the procedure, up to one day.
description: The safety endpoint is to evaluate any adverse events associated with the Nidek optical biometer or the predicate or reference devices.
measure: Additional Analyses for the Agreement Portion of the Study
time frame: Subjects will be followed for the duration of the procedure, up to one day.
description: Additional analyses will examine the intraocular lens (IOL) power calculation from the Nidek optical biometer only based on the subjects enrolled in the agreement portion of the study.
arm group label: Agreement Cohort
description: All subjects in the agreement portion of the study will have a single measurement performed with each device, the Nidek optical biometer, predicate device and ultrasound reference device. Each device will be operated by a different operator.
arm group label: Precision Cohort
description: All subjects in the precision portion of the study will each be paired with one Nidek optical biometer and with one predicate device for a total of three Nidek optical biometer/predicate device pairs. Each of the three device pairs will be designated one and only one operator. All subjects in the precision portion of the study will have their measurements repeated three times on each of three Nidek optical biometer and predicate device pairs.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karl G Stonecipher, M.D.
role: Principal Investigator
affiliation: Physicians Protocol
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Aphakia