<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/NCT01663688</url>
  </required_header>
  <id_info>
    <org_study_id>OCT RS-3000</org_study_id>
    <nct_id>NCT01663688</nct_id>
  </id_info>
  <brief_title>Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye</brief_title>
  <official_title>Normative Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for the Measurements of Retinal and RNFL Thickness and Optic Disc Analysis</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 purpose of this clinical study is to collect and evaluate the data from eye scans using&#xD;
      an investigational three-dimensional eye imaging photography device called the Nidek Optical&#xD;
      Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique&#xD;
      that uses invisible wavelengths of light to make detailed images of the tissues at the back&#xD;
      of the eye. These images provide information that physicians may use to help diagnose eye&#xD;
      conditions and/or to monitor changes in the eye during treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, open-labeled, multi-center clinical study. After qualifying&#xD;
      examination of a subject, 3D retinal measurement in the proximity of the optic disc and the&#xD;
      macula are carried out for eligible subjects with normal eyes using an investigational&#xD;
      three-dimensional eye imaging photography device called the Nidek Optical Coherence&#xD;
      Tomography (OCT) RS-3000. The primary objective of this clinical study is to develop&#xD;
      age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer&#xD;
      (RNFL) etc. using the Nidek Optical Coherence Tomography (OCT) RS-3000 with normative&#xD;
      database. The secondary objective is to evaluate any adverse events found during the clinical&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">June 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>Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis</measure>
    <time_frame>Subjects will be followed for the duration of the procedure, up to one day.</time_frame>
    <description>The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL)and Optic Disc Analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of adverse events found during the clinical study</measure>
    <time_frame>Subjects will be followed for the duration of the procedure, up to one day.</time_frame>
    <description>The secondary objective is to evaluate any adverse events found during the clinical study.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">279</enrollment>
  <condition>Ocular Physiology</condition>
  <arm_group>
    <arm_group_label>Normative Data Collection</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Normal subject eyes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal and healthy male and female subjects at least 20 years of age.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subjects who have extensive or debilitating systemic diseases.&#xD;
&#xD;
          -  Subjects who have significant ocular disease.&#xD;
&#xD;
          -  Subjects who are extremely far sighted or extremely near sighted.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert N Weinreb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamilton Glaucoma Center, UC San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Eye Institute, Keck Medical Center of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis, Medical Center, Department of Ophthalmology &amp; Vision Science</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>July 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>January 16, 2014</last_update_submitted>
  <last_update_submitted_qc>January 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01663688
org study id: OCT RS-3000
nct id: NCT01663688
lead sponsor: 
has dmc: No
The purpose of this clinical study is to collect and evaluate the data from eye scans using
      an investigational three-dimensional eye imaging photography device called the Nidek Optical
      Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique
      that uses invisible wavelengths of light to make detailed images of the tissues at the back
      of the eye. These images provide information that physicians may use to help diagnose eye
      conditions and/or to monitor changes in the eye during treatment.
This is a prospective, open-labeled, multi-center clinical study. After qualifying
      examination of a subject, 3D retinal measurement in the proximity of the optic disc and the
      macula are carried out for eligible subjects with normal eyes using an investigational
      three-dimensional eye imaging photography device called the Nidek Optical Coherence
      Tomography (OCT) RS-3000. The primary objective of this clinical study is to develop
      age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer
      (RNFL) etc. using the Nidek Optical Coherence Tomography (OCT) RS-3000 with normative
      database. The secondary objective is to evaluate any adverse events found during the clinical
      study.
observational model: Case-Only
time perspective: Prospective
measure: Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis
time frame: Subjects will be followed for the duration of the procedure, up to one day.
description: The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL)and Optic Disc Analysis.
measure: Evaluation of adverse events found during the clinical study
time frame: Subjects will be followed for the duration of the procedure, up to one day.
description: The secondary objective is to evaluate any adverse events found during the clinical study.
arm group label: Normative Data Collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert N Weinreb, MD
role: Principal Investigator
affiliation: Hamilton Glaucoma Center, UC San Diego
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor