<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/NCT03839888</url>
  </required_header>
  <id_info>
    <org_study_id>BuddhistTCGHTaipei2</org_study_id>
    <nct_id>NCT03839888</nct_id>
  </id_info>
  <brief_title>Short Term Refractive and Ocular Parameter Changes After Topical Atropine</brief_title>
  <official_title>Short Term Refractive and Ocular Parameter Changes After Topical Atropine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In order we had designed a prospective clinical trial. Spherical equivalent refractive error&#xD;
      (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and&#xD;
      intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125%&#xD;
      atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated,&#xD;
      and their correlations were analyzed with multiple linear regression models.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SER</measure>
    <time_frame>change from SER at 7 days</time_frame>
    <description>Spherical equivalent refractive error</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AL</measure>
    <time_frame>change from AL at 7 days</time_frame>
    <description>Axial length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACD</measure>
    <time_frame>change from ACD at 7 days</time_frame>
    <description>anterior chamber depth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOP</measure>
    <time_frame>change from IOP at 7 days</time_frame>
    <description>intraocular pressure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Myopia, Left Eye</condition>
  <arm_group>
    <arm_group_label>0.125% atropine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients used the 0.125 % atropine eyedrop every night before sleep for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.125% Atropine</intervention_name>
    <description>patients used 0.125% atropine eyedrop per night before sleep for 7 days.</description>
    <arm_group_label>0.125% atropine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had an SER of -0.5 diopters or less in their eyes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had already been undergoing cycloplegic treatment for myopia before.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atropine</keyword>
  <keyword>cycloplegia</keyword>
  <keyword>refraction</keyword>
  <keyword>axial length</keyword>
  <keyword>anterior chamber depth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atropine</mesh_term>
  </intervention_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/NCT03839888
org study id: BuddhistTCGHTaipei2
nct id: NCT03839888
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In order we had designed a prospective clinical trial. Spherical equivalent refractive error
      (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and
      intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125%
      atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated,
      and their correlations were analyzed with multiple linear regression models.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SER
time frame: change from SER at 7 days
description: Spherical equivalent refractive error
measure: AL
time frame: change from AL at 7 days
description: Axial length
measure: ACD
time frame: change from ACD at 7 days
description: anterior chamber depth
measure: IOP
time frame: change from IOP at 7 days
description: intraocular pressure
arm group label: 0.125% atropine group
arm group type: Experimental
description: patients used the 0.125 % atropine eyedrop every night before sleep for 7 days
intervention type: Drug
intervention name: 0.125% Atropine
description: patients used 0.125% atropine eyedrop per night before sleep for 7 days.
arm group label: 0.125% atropine group
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Myopia
mesh term: Atropine