<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/NCT04429659</url>
  </required_header>
  <id_info>
    <org_study_id>Sakarya strabismus</org_study_id>
    <nct_id>NCT04429659</nct_id>
  </id_info>
  <brief_title>Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia</brief_title>
  <official_title>Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakarya 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>
      To investigate changes in refractive errors and evaluate clinical outcomes of strabismus&#xD;
      surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic&#xD;
      patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative&#xD;
      esotropia (RAET) were included in the study as a control group. Preoperative and&#xD;
      postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism,&#xD;
      stereoacuity and deviations at near and distance were evaluated and statistically compared in&#xD;
      the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the&#xD;
      control groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of&#xD;
      strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).&#xD;
&#xD;
      Material-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full&#xD;
      refractive accommodative esotropia (RAET) were included in the study as a control group.&#xD;
      Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent&#xD;
      (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and&#xD;
      statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared&#xD;
      between the patient and the control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">September 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>spherical equivalent</measure>
    <time_frame>36 months</time_frame>
    <description>spherical error plus half of the cylindirical error measured by retinoscopy, diopter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cylindirical error</measure>
    <time_frame>36 months</time_frame>
    <description>cylindirical error measured by retinoscopy, diopter</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">58</enrollment>
  <condition>Refractive Errors</condition>
  <condition>Esotropia</condition>
  <condition>Amblyopia Strabismic</condition>
  <arm_group>
    <arm_group_label>Group 1, patients with amblyopia and partially refractive ET</arm_group_label>
    <description>children with both amblyopia and partially refractive accommodative esotropia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2, patients with refractive ET</arm_group_label>
    <description>children with refractive esotropia</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        study population was composed of amblyopic children with partially refractive ET.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        amblyopic children with partially refractive accommodative esotropia as study group non-&#xD;
        amblyopic children with fully refractive accommodative esotropia as control group&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Systemic diseases Neurological disorders and diseases Additional ocular diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Burcin Cakir, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sakarya University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sakarya University Ophthalmology Department</name>
      <address>
        <city>Sakarya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</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>Esotropia</mesh_term>
    <mesh_term>Refractive Errors</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/NCT04429659
org study id: Sakarya strabismus
nct id: NCT04429659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate changes in refractive errors and evaluate clinical outcomes of strabismus
      surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic
      patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative
      esotropia (RAET) were included in the study as a control group. Preoperative and
      postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism,
      stereoacuity and deviations at near and distance were evaluated and statistically compared in
      the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the
      control groups.
Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of
      strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).

      Material-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full
      refractive accommodative esotropia (RAET) were included in the study as a control group.
      Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent
      (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and
      statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared
      between the patient and the control groups.
observational model: Case-Control
time perspective: Retrospective
measure: spherical equivalent
time frame: 36 months
description: spherical error plus half of the cylindirical error measured by retinoscopy, diopter
measure: cylindirical error
time frame: 36 months
description: cylindirical error measured by retinoscopy, diopter
arm group label: Group 1, patients with amblyopia and partially refractive ET
description: children with both amblyopia and partially refractive accommodative esotropia
arm group label: Group 2, patients with refractive ET
description: children with refractive esotropia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 15 Years
healthy volunteers: No
last name: Burcin Cakir, MD
role: Study Chair
affiliation: Sakarya University
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Amblyopia
mesh term: Esotropia
mesh term: Refractive Errors