<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/NCT02231606</url>
  </required_header>
  <id_info>
    <org_study_id>ZOC-PRICE</org_study_id>
    <nct_id>NCT02231606</nct_id>
  </id_info>
  <brief_title>Potentiating Rural Investment in Children's Eyecare (PRICE)</brief_title>
  <acronym>PRICE</acronym>
  <official_title>Potentiating Rural Investment in Children's Eyecare (PRICE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orbis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Fred Hollows Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rural Education Action Project</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second People's Hospital of Yunnan Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the project is to create, study and advocate for a model that can be adopted by&#xD;
      the Chinese government to provide spectacles for all children sustainable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uncorrected refractive error (URE) is the leading cause of visual impairment among Chinese&#xD;
      children, accounting for 90% or more of poor vision, and Chinese children have among the&#xD;
      highest rates of myopia in the world. Despite the fact that the problem of URE is safely and&#xD;
      inexpensively treated with glasses, only 15-40% of children needing them own and wear glasses&#xD;
      sufficient to provide good vision in rural China.&#xD;
&#xD;
      PRICE (Potentiating Rural Investment in Children's Eyecare) will use a randomized, controlled&#xD;
      design across 4 groups of all 138 schools in Yunnan (one of China's poorest provinces) and&#xD;
      Guangdong (one of the richest) to optimize the model of &quot;free glasses for all with an&#xD;
      optional upgrade.&quot; The selection of free spectacles and cost of the &quot;upgrade&quot; options will be&#xD;
      varied between groups in order to find the optimal balance between high rates of purchase of&#xD;
      upgrade glasses on the one hand and good acceptance and wear of free spectacles among those&#xD;
      selecting them on the other.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glasses purchase proportion</measure>
    <time_frame>8 months after the start of the project.</time_frame>
    <description>Proportion of children in each group requiring glasses whose families select to purchase them.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wearing spectacles proportion</measure>
    <time_frame>8 months after the start of the project.</time_frame>
    <description>Proportion of children who actually wearing glasses at an unannounced check at endline survey.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Visual acuity</measure>
    <time_frame>At the first week of the study, two months later, and six months later.</time_frame>
    <description>There are three times of vision acuity(VA) check. The baseline VA, the fraction VA and the endline VA with and without glasses</description>
  </other_outcome>
  <other_outcome>
    <measure>Mydriatic refraction results</measure>
    <time_frame>One month after visual screening.</time_frame>
    <description>Those uncorrected VA ≤ 6/12 in either eye and 25% of the students whose uncorrected VA &gt; 6/12 in both eyes will receive mydriatic refraction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Family economic conditions</measure>
    <time_frame>At the first week of the study</time_frame>
    <description>Collect the children's family economic information on baseline survey.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">10234</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Group 1: Pure Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Provision of glasses prescription only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Free Glasses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Free glasses for all, no upgrade glasses offered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Free + Upgrade Glasses 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Free glasses for all, optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: Free + Upgrade Glasses 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Free glasses for all, optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Free Glasses</intervention_name>
    <description>Provide free glasses</description>
    <arm_group_label>Group 2: Free Glasses</arm_group_label>
    <arm_group_label>Group 3: Free + Upgrade Glasses 1</arm_group_label>
    <arm_group_label>Group 4: Free + Upgrade Glasses 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Upgrade Glasses 1</intervention_name>
    <description>Provide optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD)</description>
    <arm_group_label>Group 3: Free + Upgrade Glasses 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Upgrade Glasses 2</intervention_name>
    <description>Provide optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD)</description>
    <arm_group_label>Group 4: Free + Upgrade Glasses 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Randomly selected primary schools, which has all 3, 4 and 5 grades, in the 9 project&#xD;
             counties.&#xD;
&#xD;
          2. A class randomly selected from each grade of 3, 4, and 5 grades of the selected&#xD;
             primary schools.&#xD;
&#xD;
          3. All children in the selected classes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those schools that the total number of students are more than 2000.&#xD;
&#xD;
          2. Those schools that the total number of students of 3, 4, 5 grades are less than 80.&#xD;
&#xD;
          3. Children suffering from eye diseases such as cataract, congenital ptosis, strabismus,&#xD;
             congenital glaucoma will not be included in the study and will be recommended&#xD;
             referral.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Congdon, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.</citation>
    <PMID>14985292</PMID>
  </reference>
  <reference>
    <citation>Zhou Z, Zeng J, Ma X, Pang X, Yi H, Chen Q, Meltzer ME, He M, Rozelle S, Congdon N. Accuracy of rural refractionists in western China. Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):154-61. doi: 10.1167/iovs.13-13250.</citation>
    <PMID>24327616</PMID>
  </reference>
  <reference>
    <citation>Li L, Lam J, Lu Y, Ye Y, Lam DS, Gao Y, Sharma A, Zhang M, Griffiths S, Congdon N. Attitudes of students, parents, and teachers toward glasses use in rural China. Arch Ophthalmol. 2010 Jun;128(6):759-65. doi: 10.1001/archophthalmol.2010.73.</citation>
    <PMID>20547954</PMID>
  </reference>
  <reference>
    <citation>He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719.</citation>
    <PMID>19104465</PMID>
  </reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>March 7, 2016</last_update_submitted>
  <last_update_submitted_qc>March 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Congdon Nathan</investigator_full_name>
    <investigator_title>Professor, MD,MPH</investigator_title>
  </responsible_party>
  <keyword>Myopia Prevalence</keyword>
  <keyword>Proportion of Purchase of free Spectacles</keyword>
  <keyword>Proportion of Purchase of update Spectacles</keyword>
  <keyword>Proportion of Wearing Spectacles</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>Methamphetamine</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/NCT02231606
org study id: ZOC-PRICE
nct id: NCT02231606
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of the project is to create, study and advocate for a model that can be adopted by
      the Chinese government to provide spectacles for all children sustainable.
Uncorrected refractive error (URE) is the leading cause of visual impairment among Chinese
      children, accounting for 90% or more of poor vision, and Chinese children have among the
      highest rates of myopia in the world. Despite the fact that the problem of URE is safely and
      inexpensively treated with glasses, only 15-40% of children needing them own and wear glasses
      sufficient to provide good vision in rural China.

      PRICE (Potentiating Rural Investment in Children's Eyecare) will use a randomized, controlled
      design across 4 groups of all 138 schools in Yunnan (one of China's poorest provinces) and
      Guangdong (one of the richest) to optimize the model of "free glasses for all with an
      optional upgrade." The selection of free spectacles and cost of the "upgrade" options will be
      varied between groups in order to find the optimal balance between high rates of purchase of
      upgrade glasses on the one hand and good acceptance and wear of free spectacles among those
      selecting them on the other.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Glasses purchase proportion
time frame: 8 months after the start of the project.
description: Proportion of children in each group requiring glasses whose families select to purchase them.
measure: Wearing spectacles proportion
time frame: 8 months after the start of the project.
description: Proportion of children who actually wearing glasses at an unannounced check at endline survey.
measure: Visual acuity
time frame: At the first week of the study, two months later, and six months later.
description: There are three times of vision acuity(VA) check. The baseline VA, the fraction VA and the endline VA with and without glasses
measure: Mydriatic refraction results
time frame: One month after visual screening.
description: Those uncorrected VA ≤ 6/12 in either eye and 25% of the students whose uncorrected VA > 6/12 in both eyes will receive mydriatic refraction.
measure: Family economic conditions
time frame: At the first week of the study
description: Collect the children's family economic information on baseline survey.
arm group label: Group 1: Pure Control
arm group type: No Intervention
description: Provision of glasses prescription only
arm group label: Group 2: Free Glasses
arm group type: Experimental
description: Free glasses for all, no upgrade glasses offered
arm group label: Group 3: Free + Upgrade Glasses 1
arm group type: Experimental
description: Free glasses for all, optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD)
arm group label: Group 4: Free + Upgrade Glasses 2
arm group type: Experimental
description: Free glasses for all, optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD)
intervention type: Other
intervention name: Free Glasses
description: Provide free glasses
arm group label: Group 2: Free Glasses
arm group label: Group 3: Free + Upgrade Glasses 1
arm group label: Group 4: Free + Upgrade Glasses 2
intervention type: Other
intervention name: Upgrade Glasses 1
description: Provide optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD)
arm group label: Group 3: Free + Upgrade Glasses 1
intervention type: Other
intervention name: Upgrade Glasses 2
description: Provide optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD)
arm group label: Group 4: Free + Upgrade Glasses 2
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: No
last name: Nathan Congdon, MD, MPH
role: Principal Investigator
affiliation: The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
citation: He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
PMID: 14985292
citation: Zhou Z, Zeng J, Ma X, Pang X, Yi H, Chen Q, Meltzer ME, He M, Rozelle S, Congdon N. Accuracy of rural refractionists in western China. Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):154-61. doi: 10.1167/iovs.13-13250.
PMID: 24327616
citation: Li L, Lam J, Lu Y, Ye Y, Lam DS, Gao Y, Sharma A, Zhang M, Griffiths S, Congdon N. Attitudes of students, parents, and teachers toward glasses use in rural China. Arch Ophthalmol. 2010 Jun;128(6):759-65. doi: 10.1001/archophthalmol.2010.73.
PMID: 20547954
citation: He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719.
PMID: 19104465
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Congdon Nathan
investigator title: Professor, MD,MPH
mesh term: Myopia
mesh term: Methamphetamine