<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/NCT01706991</url>
  </required_header>
  <id_info>
    <org_study_id>rebiscan-003</org_study_id>
    <nct_id>NCT01706991</nct_id>
  </id_info>
  <brief_title>Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner</brief_title>
  <official_title>MEPEDS New Device Pediatric Vision Scanner</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rebiscan, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rebiscan, Inc.</source>
  <brief_summary>
    <textblock>
      The purpose of this project is to compare the performance of the Pediatric Vision Scanner&#xD;
      (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at&#xD;
      detecting amblyopia and strabismus. All tests and observations will be done at a single visit&#xD;
      over the course of approximately 30 minutes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Binocularity score</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of amblyopia risk factors</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Amblyopia</condition>
  <condition>Strabismus</condition>
  <arm_group>
    <arm_group_label>Normal Controls</arm_group_label>
    <description>Structurally normal eye with equal visual acuity and normal stereopsis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Referral required</arm_group_label>
    <description>Diagnosed with amblyopia or constant strabismus, categorized based on the GSE.&#xD;
Amblyopia:&#xD;
VA &lt;20/40 and 2 logMAR lines difference in normal eye&#xD;
Mild amblyopia (&gt;20/40)&#xD;
Moderate amblyopia (20/40 and &lt;20/100)&#xD;
Severe amblyopia (≥20/100 or worse)&#xD;
Bilateral amblyopia: &gt;4 years age VA&lt;20/40 OU including high hyperopia or high astigmatism.&#xD;
Strabismus:&#xD;
Constant: &gt;2 PD at near and or distance.&#xD;
Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position.&#xD;
Amblyogenic factor categorization:&#xD;
'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes.&#xD;
'hypermetropia' (≥3.5 D),&#xD;
'myopia' (≥-4.0 D),&#xD;
'astigmatism' (≥1.5 D).&#xD;
'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Borderline</arm_group_label>
    <description>(no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pediatric Vision Scanner eye scan</intervention_name>
    <description>Subject is scanned with a 2.5 second pediatric vision scanner device test.</description>
    <arm_group_label>Borderline</arm_group_label>
    <arm_group_label>Normal Controls</arm_group_label>
    <arm_group_label>Referral required</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children presenting for ophthalmic exam at eye clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 6 months to 6 years&#xD;
&#xD;
          -  Signed Informed consent by parent or guardian&#xD;
&#xD;
          -  Meet all inclusion criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with a history of developmental delay or cognitive deficit&#xD;
&#xD;
          -  Children unable to complete the GSE (including visual acuity testing)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rohit Varma, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Doheny Eye Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.</citation>
    <PMID>21642624</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</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>Amblyopia</mesh_term>
    <mesh_term>Strabismus</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/NCT01706991
org study id: rebiscan-003
nct id: NCT01706991
lead sponsor: 
collaborator: 
The purpose of this project is to compare the performance of the Pediatric Vision Scanner
      (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at
      detecting amblyopia and strabismus. All tests and observations will be done at a single visit
      over the course of approximately 30 minutes.
observational model: Case-Control
time perspective: Prospective
measure: Binocularity score
time frame: Day 1
measure: Presence of amblyopia risk factors
time frame: Day 1
arm group label: Normal Controls
description: Structurally normal eye with equal visual acuity and normal stereopsis.
arm group label: Referral required
description: Diagnosed with amblyopia or constant strabismus, categorized based on the GSE.
Amblyopia:
VA <20/40 and 2 logMAR lines difference in normal eye
Mild amblyopia (>20/40)
Moderate amblyopia (20/40 and <20/100)
Severe amblyopia (≥20/100 or worse)
Bilateral amblyopia: >4 years age VA<20/40 OU including high hyperopia or high astigmatism.
Strabismus:
Constant: >2 PD at near and or distance.
Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position.
Amblyogenic factor categorization:
'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes.
'hypermetropia' (≥3.5 D),
'myopia' (≥-4.0 D),
'astigmatism' (≥1.5 D).
'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse.
arm group label: Borderline
description: (no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis.
intervention type: Device
intervention name: Pediatric Vision Scanner eye scan
description: Subject is scanned with a 2.5 second pediatric vision scanner device test.
arm group label: Borderline
arm group label: Normal Controls
arm group label: Referral required
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rohit Varma, MD, PhD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
citation: Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.
PMID: 21642624
responsible party type: Sponsor
mesh term: Amblyopia
mesh term: Strabismus