<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/NCT04432181</url>
  </required_header>
  <id_info>
    <org_study_id>sakarya amblyopia</org_study_id>
    <nct_id>NCT04432181</nct_id>
  </id_info>
  <brief_title>Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia</brief_title>
  <official_title>Associated Professor, Director of Strabismus Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakarya University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the records of astigmatic children were reviewed and any deviation was investigated at near&#xD;
      and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated.&#xD;
      children were divided into two groups according to the presence of amblyopia and ocular&#xD;
      deviations and other parameters were compared between groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study was to evaluate deviations in children with ≥1,75 diopter (D)&#xD;
      astigmatism with or without amblyopia.&#xD;
&#xD;
      The records of children with ≥1,75 D astigmatism were investigated. Subjects with and without&#xD;
      amblyopia composed group 1 and 2, respectively. The mean age, gender, amount and type of&#xD;
      deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle&#xD;
      use and follow-up time, differences in best corrected visual acuity (VoD) and spherical&#xD;
      equivalent (SE) between eyes were noted and compared between the groups. Best corrected&#xD;
      visual acuity (BCVA), mean SE, astigmatism measurements were also noted and compared between&#xD;
      amblyopic, fellow and non-amblyopic eyes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2018</start_date>
  <completion_date type="Actual">February 3, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>30 Months</target_duration>
  <primary_outcome>
    <measure>ocular deviation</measure>
    <time_frame>24 month</time_frame>
    <description>ocular deviation measured by alternate prism cover test, prism diopter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>convergence</measure>
    <time_frame>24 month</time_frame>
    <description>presence of convergence insufficiency at 10 cm far from visual axe.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Astigmatism of Both Eyes</condition>
  <condition>Amblyopia</condition>
  <condition>Strabismus</condition>
  <arm_group>
    <arm_group_label>Group 1, astigmatic patients with amblyopia</arm_group_label>
    <description>astigmatic children with amblyopia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2, astigmatic patients without amblyopia</arm_group_label>
    <description>astigmatic children without amblyopia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ophthalmic examination</intervention_name>
    <description>ophthalmic examination including; best corrected visual acuity, alternating prism cover test, retinoscopy, fundus examination, ocular vergence evaluation</description>
    <arm_group_label>Group 1, astigmatic patients with amblyopia</arm_group_label>
    <arm_group_label>Group 2, astigmatic patients without amblyopia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        children age range between 7 and 13 years with ≥1,75 diopter (D) astigmatism were included.&#xD;
        Patients with additional ocular and systemic diseases were excluded in this study. Subjects&#xD;
        with and without amblyopia composed group 1 and 2, respectively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  astigmatisma ≥1,75 Diopter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases additional ocular diseases neurological diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Burcin Cakir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sakarya University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sakarya University Ophthalmology Department</name>
      <address>
        <city>Sakarya</city>
        <zip>54000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sakarya University</investigator_affiliation>
    <investigator_full_name>Burçin Çakır</investigator_full_name>
    <investigator_title>Burcin Cakir, FICO</investigator_title>
  </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>
    <mesh_term>Astigmatism</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/NCT04432181
org study id: sakarya amblyopia
nct id: NCT04432181
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
the records of astigmatic children were reviewed and any deviation was investigated at near
      and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated.
      children were divided into two groups according to the presence of amblyopia and ocular
      deviations and other parameters were compared between groups.
The aim of the study was to evaluate deviations in children with ≥1,75 diopter (D)
      astigmatism with or without amblyopia.

      The records of children with ≥1,75 D astigmatism were investigated. Subjects with and without
      amblyopia composed group 1 and 2, respectively. The mean age, gender, amount and type of
      deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle
      use and follow-up time, differences in best corrected visual acuity (VoD) and spherical
      equivalent (SE) between eyes were noted and compared between the groups. Best corrected
      visual acuity (BCVA), mean SE, astigmatism measurements were also noted and compared between
      amblyopic, fellow and non-amblyopic eyes.
observational model: Case-Control
time perspective: Prospective
measure: ocular deviation
time frame: 24 month
description: ocular deviation measured by alternate prism cover test, prism diopter
measure: convergence
time frame: 24 month
description: presence of convergence insufficiency at 10 cm far from visual axe.
arm group label: Group 1, astigmatic patients with amblyopia
description: astigmatic children with amblyopia
arm group label: Group 2, astigmatic patients without amblyopia
description: astigmatic children without amblyopia
intervention type: Other
intervention name: ophthalmic examination
description: ophthalmic examination including; best corrected visual acuity, alternating prism cover test, retinoscopy, fundus examination, ocular vergence evaluation
arm group label: Group 1, astigmatic patients with amblyopia
arm group label: Group 2, astigmatic patients without amblyopia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 13 Years
last name: Burcin Cakir, MD
role: Principal Investigator
affiliation: Sakarya University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Sakarya University
investigator full name: Burçin Çakır
investigator title: Burcin Cakir, FICO
mesh term: Amblyopia
mesh term: Strabismus
mesh term: Astigmatism