<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/NCT03251456</url>
  </required_header>
  <id_info>
    <org_study_id>SYSU-OPH-002</org_study_id>
    <nct_id>NCT03251456</nct_id>
  </id_info>
  <brief_title>Tertiary Care for Visual Developmental Disorders in Pre-school Children</brief_title>
  <official_title>Tertiary Care Based Visual Developmental Diseases Management Model Among Preschool Children in China: a Cluster Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</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>
      Visual development disorders are major public health problems among children especially in&#xD;
      China. How to find an effective and economic way to manage the larger number of children in&#xD;
      China remains exploring. The national basic public health services of China offer visual&#xD;
      acuity screening for preschool children for free every year. The aim of this study is to&#xD;
      demonstrate the feasibility, cost-effective and the influence factors of compliance of&#xD;
      tertiary care for visual developmental disorders in pre-school children after screening, and&#xD;
      whether this disease management model is more effective and superior than the current medical&#xD;
      care in china.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visual development disorders including amblyopia , strabismus ,refractive error are an&#xD;
      important public health problem among children, and the visual impairment caused by visual&#xD;
      development disorders is lifelong and can be profound. Timely discovering and treatment of&#xD;
      visual development disorders are significant for the recovering of visual function in&#xD;
      children. The national basic public health services of China offer the basic visual acuity&#xD;
      screening every year for free. In this study, the investigators try to explore the&#xD;
      cost-effective and compliance of the national basic public health services based tertiary&#xD;
      care model for the management of visual development disorders among preschool children. This&#xD;
      Tertiary care based on disease management model among preschool children was conducted at&#xD;
      Yudu county, Jiangxi province, in China. Preschool vision screening relied on the national&#xD;
      basic public health services of China (refractive errors examined by the Retinomax&#xD;
      autorefractor). Children who failed the screening were randomized into two groups, the&#xD;
      intervention group: their parents will be informed and transferred to an ophthalmologist and&#xD;
      optometrist at Ophthalmic Referral Center, receiving basic eye examination and therapy&#xD;
      (visual corrected by glasses and periodic review); The control group: their parents will be&#xD;
      informed and suggest them to take their children to the hospital for further examination by&#xD;
      themselves.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The consultation rate in six month after the parents receiving the visual screening report</measure>
    <time_frame>6 months</time_frame>
    <description>The consultation rate will be determined by the number of children who had visual screening abnormal actually go to hospital for consultation by telephone follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The cost-effective of the tertiary care for visual developmental disorders</measure>
    <time_frame>6 months</time_frame>
    <description>The cost of the disease management model will be determined by the cost per child when receiving the therapy including the travelling and medical fee, and the time they spent. And the clinical efficacy of the tertiary care for visual developmental disorders will be determined by whether or not the child receiving the appropriate therapy according to the clinical guideline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1114</enrollment>
  <condition>Visual Developmental Disorders</condition>
  <arm_group>
    <arm_group_label>Tertiary care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tertiary care</intervention_name>
    <description>Inform the parents that there are abnormalities after eye disease screening of their children, and the program of tertiary care for visual developmental disorders&#xD;
The children will be receiving the appropriate therapy in tertiary care and follow-up according to the clinical guidelines&#xD;
Six months after receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.</description>
    <arm_group_label>Tertiary care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Inform the parents that there are abnormalities after eye disease screening of their children&#xD;
Inform the parents that they should take their children to the hospital for further consultation&#xD;
Six months after the receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who are aged 4-7 years and of Chinese citizen&#xD;
&#xD;
          2. Who is willing to sign the consent form&#xD;
&#xD;
          3. Children at the kindergarten will receiving the eye diseases screening of public&#xD;
             health equalization programs in China, and there are abnormal findings after screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling to sign the consent form&#xD;
&#xD;
          2. Exiting eye diseases and already receiving therapies and follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yizhi LIU, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yangfa ZENG, MD,Master</last_name>
    <role>Study Director</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yudu</name>
      <address>
        <city>Ganzhou</city>
        <state>Jiangxi</state>
        <zip>342300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Vision in Preschoolers Study Group. Preschool vision screening tests administered by nurse screeners compared with lay screeners in the vision in preschoolers study. Invest Ophthalmol Vis Sci. 2005 Aug;46(8):2639-48. doi: 10.1167/iovs.05-0141.</citation>
    <PMID>16043831</PMID>
  </reference>
  <reference>
    <citation>Hendler K, Mehravaran S, Lu X, Brown SI, Mondino BJ, Coleman AL. Refractive Errors and Amblyopia in the UCLA Preschool Vision Program; First Year Results. Am J Ophthalmol. 2016 Dec;172:80-86. doi: 10.1016/j.ajo.2016.09.010. Epub 2016 Sep 14.</citation>
    <PMID>27640004</PMID>
  </reference>
  <reference>
    <citation>US Preventive Services Task Force. Vision screening for children 1 to 5 years of age: US Preventive Services Task Force Recommendation statement. Pediatrics. 2011 Feb;127(2):340-6. doi: 10.1542/peds.2010-3177. Epub 2011 Jan 31.</citation>
    <PMID>21282267</PMID>
  </reference>
  <reference>
    <citation>Konig HH, Barry JC. Cost effectiveness of treatment for amblyopia: an analysis based on a probabilistic Markov model. Br J Ophthalmol. 2004 May;88(5):606-12. doi: 10.1136/bjo.2003.028712.</citation>
    <PMID>15090409</PMID>
  </reference>
  <reference>
    <citation>Kemper AR, Wallace DK, Patel N, Crews JE. Preschool vision testing by health providers in the United States: findings from the 2006-2007 Medical Expenditure Panel Survey. J AAPOS. 2011 Oct;15(5):480-3. doi: 10.1016/j.jaapos.2011.07.007.</citation>
    <PMID>22108361</PMID>
  </reference>
  <reference>
    <citation>Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. Epub 2013 Jan 27.</citation>
    <PMID>23360915</PMID>
  </reference>
  <reference>
    <citation>Donahue SP. Prescribing spectacles in children: a pediatric ophthalmologist's approach. Optom Vis Sci. 2007 Feb;84(2):110-4. doi: 10.1097/OPX.0b013e318031b09b.</citation>
    <PMID>17299340</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Yizhi Liu</investigator_full_name>
    <investigator_title>Clinical Professor,director of Zhongshan Ophthalmic Center</investigator_title>
  </responsible_party>
  <keyword>myopia</keyword>
  <keyword>Tertiary Care</keyword>
  <keyword>Pre-school Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Developmental Disabilities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03251456
org study id: SYSU-OPH-002
nct id: NCT03251456
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Visual development disorders are major public health problems among children especially in
      China. How to find an effective and economic way to manage the larger number of children in
      China remains exploring. The national basic public health services of China offer visual
      acuity screening for preschool children for free every year. The aim of this study is to
      demonstrate the feasibility, cost-effective and the influence factors of compliance of
      tertiary care for visual developmental disorders in pre-school children after screening, and
      whether this disease management model is more effective and superior than the current medical
      care in china.
Visual development disorders including amblyopia , strabismus ,refractive error are an
      important public health problem among children, and the visual impairment caused by visual
      development disorders is lifelong and can be profound. Timely discovering and treatment of
      visual development disorders are significant for the recovering of visual function in
      children. The national basic public health services of China offer the basic visual acuity
      screening every year for free. In this study, the investigators try to explore the
      cost-effective and compliance of the national basic public health services based tertiary
      care model for the management of visual development disorders among preschool children. This
      Tertiary care based on disease management model among preschool children was conducted at
      Yudu county, Jiangxi province, in China. Preschool vision screening relied on the national
      basic public health services of China (refractive errors examined by the Retinomax
      autorefractor). Children who failed the screening were randomized into two groups, the
      intervention group: their parents will be informed and transferred to an ophthalmologist and
      optometrist at Ophthalmic Referral Center, receiving basic eye examination and therapy
      (visual corrected by glasses and periodic review); The control group: their parents will be
      informed and suggest them to take their children to the hospital for further examination by
      themselves.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The consultation rate in six month after the parents receiving the visual screening report
time frame: 6 months
description: The consultation rate will be determined by the number of children who had visual screening abnormal actually go to hospital for consultation by telephone follow-up.
measure: The cost-effective of the tertiary care for visual developmental disorders
time frame: 6 months
description: The cost of the disease management model will be determined by the cost per child when receiving the therapy including the travelling and medical fee, and the time they spent. And the clinical efficacy of the tertiary care for visual developmental disorders will be determined by whether or not the child receiving the appropriate therapy according to the clinical guideline.
arm group label: Tertiary care
arm group type: Experimental
arm group label: Usual care
arm group type: Active Comparator
intervention type: Other
intervention name: Tertiary care
description: Inform the parents that there are abnormalities after eye disease screening of their children, and the program of tertiary care for visual developmental disorders
The children will be receiving the appropriate therapy in tertiary care and follow-up according to the clinical guidelines
Six months after receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.
arm group label: Tertiary care
intervention type: Other
intervention name: Usual Care
description: Inform the parents that there are abnormalities after eye disease screening of their children
Inform the parents that they should take their children to the hospital for further consultation
Six months after the receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary.
arm group label: Usual care
criteria: 
gender: All
minimum age: 4 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yizhi LIU, MD,PhD
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
last name: Yangfa ZENG, MD,Master
role: Study Director
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
citation: Vision in Preschoolers Study Group. Preschool vision screening tests administered by nurse screeners compared with lay screeners in the vision in preschoolers study. Invest Ophthalmol Vis Sci. 2005 Aug;46(8):2639-48. doi: 10.1167/iovs.05-0141.
PMID: 16043831
citation: Hendler K, Mehravaran S, Lu X, Brown SI, Mondino BJ, Coleman AL. Refractive Errors and Amblyopia in the UCLA Preschool Vision Program; First Year Results. Am J Ophthalmol. 2016 Dec;172:80-86. doi: 10.1016/j.ajo.2016.09.010. Epub 2016 Sep 14.
PMID: 27640004
citation: US Preventive Services Task Force. Vision screening for children 1 to 5 years of age: US Preventive Services Task Force Recommendation statement. Pediatrics. 2011 Feb;127(2):340-6. doi: 10.1542/peds.2010-3177. Epub 2011 Jan 31.
PMID: 21282267
citation: Konig HH, Barry JC. Cost effectiveness of treatment for amblyopia: an analysis based on a probabilistic Markov model. Br J Ophthalmol. 2004 May;88(5):606-12. doi: 10.1136/bjo.2003.028712.
PMID: 15090409
citation: Kemper AR, Wallace DK, Patel N, Crews JE. Preschool vision testing by health providers in the United States: findings from the 2006-2007 Medical Expenditure Panel Survey. J AAPOS. 2011 Oct;15(5):480-3. doi: 10.1016/j.jaapos.2011.07.007.
PMID: 22108361
citation: Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. Epub 2013 Jan 27.
PMID: 23360915
citation: Donahue SP. Prescribing spectacles in children: a pediatric ophthalmologist's approach. Optom Vis Sci. 2007 Feb;84(2):110-4. doi: 10.1097/OPX.0b013e318031b09b.
PMID: 17299340
responsible party type: Principal Investigator
investigator affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
investigator full name: Yizhi Liu
investigator title: Clinical Professor,director of Zhongshan Ophthalmic Center
mesh term: Developmental Disabilities
sharing ipd: No