<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/NCT03780205</url>
  </required_header>
  <id_info>
    <org_study_id>HJWSH1810</org_study_id>
    <nct_id>NCT03780205</nct_id>
  </id_info>
  <brief_title>Bilateral and Unilateral Amblyopia Treatment Study</brief_title>
  <official_title>Objective Adherence With Optical Correction in Children With Bilateral and Unilateral Refractive Amblyopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Salus University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose for this study is to investigate spectacle compliance and treatment outcome in&#xD;
      bilateral and unilateral refractive amblyopia in children age 3 to &lt;10 years old.&#xD;
      Specifically, how frequently and for what duration is spectacle wear necessary to maximize&#xD;
      best-corrected visual acuity by spectacle correction alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose for this study is to investigate spectacle compliance and treatment outcome in&#xD;
      bilateral and unilateral refractive amblyopia in children age 3 to &lt;10 years old.&#xD;
      Specifically, how frequently and for what duration is spectacle wear necessary to maximize&#xD;
      best-corrected visual acuity by spectacle correction alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to recruit sufficient number of subjects&#xD;
  </why_stopped>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">July 7, 2020</completion_date>
  <primary_completion_date type="Actual">July 7, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>visual acuity change from the baseline</measure>
    <time_frame>8 weeks</time_frame>
    <description>visual acuity change from the baseline in logMAR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adherence with optical treatment</measure>
    <time_frame>8 weeks</time_frame>
    <description>The adherence recorded with the microsensor will be calculated as a percentage.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Bilateral Group</arm_group_label>
    <description>Patients have bilateral amblyopia, which is defined that best-corrected visual acuity of &lt;20/30 each eye.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unilateral Group</arm_group_label>
    <description>Patients have unilateral amblyopia, which is defined that best-corrected visual acuity of &lt;20/30 in the amblyopic eye; and interocular difference of best-corrected visual acuity at least two logMAR lines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prescription glasses for bilateral amblyopia</intervention_name>
    <description>Correction of refractive error with prescription glasses both eyes</description>
    <arm_group_label>Bilateral Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prescription glasses for unilateral amblyopia</intervention_name>
    <description>Correction of asymmetric refractive errors with lenses</description>
    <arm_group_label>Unilateral Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children age at 3 to &lt; 10 years, who is newly diagnosed as amblyopia and prescribed with&#xD;
        glasses.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 3 to &lt; 10 years&#xD;
&#xD;
          -  Subjects and their parent/guardian speak and understand English adequately to complete&#xD;
             the study protocol and give informed consent. Subjects have the ability to adhere to&#xD;
             the study visit schedule.&#xD;
&#xD;
          -  All refractive error measures below will be determined by cycloplegic retinoscopy by&#xD;
             one of the study investigators during the comprehensive eye exam. Measures are in&#xD;
             minus cylinder spectacle prescription format.&#xD;
&#xD;
        Inclusion criteria for bilateral amblyopia:&#xD;
&#xD;
        The major eligibility criteria include:&#xD;
&#xD;
          -  Best-corrected visual acuity of &lt;20/30 each eye.&#xD;
&#xD;
          -  For hypermetropia:&#xD;
&#xD;
               -  Spherical equivalent &gt;+2.00 D each eye.&#xD;
&#xD;
               -  Spherical equivalent difference between eyes &lt;1.25 D.&#xD;
&#xD;
          -  For astigmatism without hypermetropia criteria above or myopia criteria below:&#xD;
&#xD;
               -  &gt;1.75 D each eye&#xD;
&#xD;
               -  Difference between eyes &lt;1.25 D&#xD;
&#xD;
          -  For myopia:&#xD;
&#xD;
               -  Spherical equivalent &lt;-5.00.&#xD;
&#xD;
               -  Spherical equivalent difference between eyes &lt;1.25 D.&#xD;
&#xD;
        Inclusion criteria for unilateral amblyopia:&#xD;
&#xD;
        The major eligibility criteria include:&#xD;
&#xD;
          -  Presence of anisometropia or constant unilateral strabismus.&#xD;
&#xD;
          -  Best-corrected visual acuity in the amblyopic eye &lt;20/30; and interocular difference&#xD;
             of best-corrected visual acuity at least two logMAR lines.&#xD;
&#xD;
          -  For anisometropia:&#xD;
&#xD;
               -  Spherical equivalent ≥ 1.00 D interocular difference&#xD;
&#xD;
               -  Astigmatism &gt;1.75 D interocular difference&#xD;
&#xD;
          -  For constant unilateral strabismus where spectacle prescription is indicated. Examples&#xD;
             where spectacle prescription is indicated include esotropia caused at least in part by&#xD;
             an accommodative component or where significant refractive error in either eye&#xD;
             warrants spectacle prescription for improved vision.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of spectacle wear&#xD;
&#xD;
          -  Previous treatment for amblyopia&#xD;
&#xD;
          -  Active amblyopia treatment planned other than spectacles at enrollment&#xD;
&#xD;
          -  Prior intraocular or refractive surgery&#xD;
&#xD;
          -  Ocular or systemic abnormalities that the examining investigator deems could impact&#xD;
             prognosis for visual improvement. Examples could include birth history that may have&#xD;
             affected brain development, extremely low birth weight (&lt;1.5 lbs), seizure disorders,&#xD;
             cerebral palsy, optic nerve hypoplasia, cranial nerve palsy. Examples that would&#xD;
             usually not exclude are off axis media opacity, low birth weight (2.0-3.5 lbs) without&#xD;
             complication, mild limitation of extraocular muscle. Cognitive impairment that&#xD;
             prohibits accurate data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Stanley Hatch, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Salus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Salus University</name>
      <address>
        <city>Elkins Park</city>
        <state>Pennsylvania</state>
        <zip>19027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 27, 2020</last_update_submitted>
  <last_update_submitted_qc>August 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Salus University</investigator_affiliation>
    <investigator_full_name>Stanley Hatch, OD, MPH</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Amblyopia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amblyopia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03780205
org study id: HJWSH1810
nct id: NCT03780205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose for this study is to investigate spectacle compliance and treatment outcome in
      bilateral and unilateral refractive amblyopia in children age 3 to <10 years old.
      Specifically, how frequently and for what duration is spectacle wear necessary to maximize
      best-corrected visual acuity by spectacle correction alone.
The purpose for this study is to investigate spectacle compliance and treatment outcome in
      bilateral and unilateral refractive amblyopia in children age 3 to <10 years old.
      Specifically, how frequently and for what duration is spectacle wear necessary to maximize
      best-corrected visual acuity by spectacle correction alone.
observational model: Cohort
time perspective: Prospective
measure: visual acuity change from the baseline
time frame: 8 weeks
description: visual acuity change from the baseline in logMAR
measure: adherence with optical treatment
time frame: 8 weeks
description: The adherence recorded with the microsensor will be calculated as a percentage.
arm group label: Bilateral Group
description: Patients have bilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 each eye.
arm group label: Unilateral Group
description: Patients have unilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 in the amblyopic eye; and interocular difference of best-corrected visual acuity at least two logMAR lines.
intervention type: Other
intervention name: Prescription glasses for bilateral amblyopia
description: Correction of refractive error with prescription glasses both eyes
arm group label: Bilateral Group
intervention type: Other
intervention name: Prescription glasses for unilateral amblyopia
description: Correction of asymmetric refractive errors with lenses
arm group label: Unilateral Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
last name: Stanley Hatch, OD
role: Principal Investigator
affiliation: Salus University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Salus University
investigator full name: Stanley Hatch, OD, MPH
investigator title: Associate Professor
mesh term: Amblyopia
mesh term: Methamphetamine
sharing ipd: Undecided