<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/NCT03260764</url>
  </required_header>
  <id_info>
    <org_study_id>CCPMOH2017-China-7</org_study_id>
    <nct_id>NCT03260764</nct_id>
  </id_info>
  <brief_title>Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts</brief_title>
  <official_title>the Comparison of Multifocal Contact Lenses and Bifocal Spectacles for Congenital Cataracts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>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>
      In this study, the investigators provide participants who had congenital cataract the&#xD;
      multifocal contact lenses and bifocal spectacles in the purpose of seeking out a better way&#xD;
      to make a definite diagnosis with high efficiency and accuracy, and report a prospective,&#xD;
      randomized controlled study aiming at comparison of multifocal contact lenses and bifocal&#xD;
      spectacles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children diagnosed as cataract without treatment were enrolled to a prospective, randomized&#xD;
      controlled study. Patients were assigned to four groups: participants in group A wearing&#xD;
      multifocal contact lenses a week and then bifocal spectacles a week;in Group B, the&#xD;
      participants wearing bifocal spectacles a week and then multifocal contact lenses;in Group C,&#xD;
      the participants wearing multifocal contact lenses four a year;in Group D, the participants&#xD;
      wearing bifocal spectacles four a year. Investigators compare the acuity, refraction,&#xD;
      contrast sensitivity and the results of questionnaire between A and B , C and D groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Demography (age, sex, laterality and medical history)</measure>
    <time_frame>baseline</time_frame>
    <description>The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The refraction status (presented as spherical equivalent, SE)</measure>
    <time_frame>after wearing contact lenses one month, three months ,six months and a year</time_frame>
    <description>Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acuity</measure>
    <time_frame>after wearing contact lenses one month, three months ,six months and a year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>contrast sensitivity</measure>
    <time_frame>after wearing contact lenses one month, three months ,six months and a year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>questionnaire result</measure>
    <time_frame>after wearing contact lenses one month, three months ,six months and a year</time_frame>
    <description>the feel of wearing during different daily activities</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Multifocal Contact Lenses</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group D</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>short term Multifocal Contact Lenses</intervention_name>
    <description>wearing Multifocal Contact Lenses for one week</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>short term Bifocal Spectacles</intervention_name>
    <description>wearing Bifocal Spectacles for one week</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>long term Multifocal Contact Lenses</intervention_name>
    <description>wearing Multifocal Contact Lenses for one year</description>
    <arm_group_label>group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>long term Bifocal Spectacles</intervention_name>
    <description>wearing Bifocal Spectacles for one year</description>
    <arm_group_label>group D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed as binocular cataract&#xD;
&#xD;
          -  after the surgery of binocular intraocular lens implantation more than one month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed as xerophthalmus&#xD;
&#xD;
          -  diagnosed as other eye diseases or systemic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haotian Lin, M.D,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhognshan Ophthalmic Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Haotian Lin</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Multifocal Contact Lenses</keyword>
  <keyword>Bifocal Spectacles</keyword>
  <keyword>Congenital Cataracts</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT03260764
org study id: CCPMOH2017-China-7
nct id: NCT03260764
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators provide participants who had congenital cataract the
      multifocal contact lenses and bifocal spectacles in the purpose of seeking out a better way
      to make a definite diagnosis with high efficiency and accuracy, and report a prospective,
      randomized controlled study aiming at comparison of multifocal contact lenses and bifocal
      spectacles.
Children diagnosed as cataract without treatment were enrolled to a prospective, randomized
      controlled study. Patients were assigned to four groups: participants in group A wearing
      multifocal contact lenses a week and then bifocal spectacles a week;in Group B, the
      participants wearing bifocal spectacles a week and then multifocal contact lenses;in Group C,
      the participants wearing multifocal contact lenses four a year;in Group D, the participants
      wearing bifocal spectacles four a year. Investigators compare the acuity, refraction,
      contrast sensitivity and the results of questionnaire between A and B , C and D groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Demography (age, sex, laterality and medical history)
time frame: baseline
description: The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.
measure: The refraction status (presented as spherical equivalent, SE)
time frame: after wearing contact lenses one month, three months ,six months and a year
description: Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists
measure: acuity
time frame: after wearing contact lenses one month, three months ,six months and a year
measure: contrast sensitivity
time frame: after wearing contact lenses one month, three months ,six months and a year
measure: questionnaire result
time frame: after wearing contact lenses one month, three months ,six months and a year
description: the feel of wearing during different daily activities
arm group label: group A
arm group type: Experimental
arm group label: group B
arm group type: Placebo Comparator
arm group label: group C
arm group type: Experimental
arm group label: group D
arm group type: Placebo Comparator
intervention type: Device
intervention name: short term Multifocal Contact Lenses
description: wearing Multifocal Contact Lenses for one week
arm group label: group A
arm group label: group B
intervention type: Device
intervention name: short term Bifocal Spectacles
description: wearing Bifocal Spectacles for one week
arm group label: group A
arm group label: group B
intervention type: Device
intervention name: long term Multifocal Contact Lenses
description: wearing Multifocal Contact Lenses for one year
arm group label: group C
intervention type: Device
intervention name: long term Bifocal Spectacles
description: wearing Bifocal Spectacles for one year
arm group label: group D
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: No
last name: Haotian Lin, M.D,Ph.D
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Haotian Lin
investigator title: Clinical Professor
mesh term: Cataract