<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/NCT01726842</url>
  </required_header>
  <id_info>
    <org_study_id>rebiscan-001</org_study_id>
    <nct_id>NCT01726842</nct_id>
  </id_info>
  <brief_title>Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner</brief_title>
  <official_title>Pediatric Vision Scanner for the Eradication of Amblyopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rebiscan, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Retina Foundation of the Southwest</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.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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">300</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</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:&#xD;
&#xD;
          -  2-6 years old&#xD;
&#xD;
          -  complete ophthalmic examination including cycloplegic refraction conducted on the same&#xD;
             day or within 3 months&#xD;
&#xD;
          -  strabismic, anisometropic, or normal (normal eye examination and refractive error&#xD;
             according to AAPOS guidelines)&#xD;
&#xD;
          -  parent provides informed consent&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  other ocular disease (includes media opacities, anomalous optic nerve, ptosis, lid&#xD;
             hemangioma, conjunctivitis, blepharitis, symptomatic NLD) or systemic disease (JIA,&#xD;
             JRA, neurofibromatosis)&#xD;
&#xD;
          -  developmental delay&#xD;
&#xD;
          -  strabismus surgery in the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eileen Birch, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Retina Foundation of the Southwest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retina Foundation of the Southwest</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</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 2015</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>October 27, 2015</last_update_submitted>
  <last_update_submitted_qc>October 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 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>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/NCT01726842
org study id: rebiscan-001
nct id: NCT01726842
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.
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
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: 2 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eileen Birch, PhD
role: Principal Investigator
affiliation: Retina Foundation of the Southwest
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