<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/NCT02206217</url>
  </required_header>
  <id_info>
    <org_study_id>H-ZG3B</org_study_id>
    <nct_id>NCT02206217</nct_id>
  </id_info>
  <brief_title>Myopia Control With the Multi-segment Lens</brief_title>
  <official_title>The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HOYA Corporation (Tokyo, Japan)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can&#xD;
      slow myopia progression in Hong Kong schoolchildren.&#xD;
&#xD;
      MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal&#xD;
      spectacle lens which corrects distance refractive error and at the same time produces myopic&#xD;
      defocus images on the retina for all distances. The myopic defocus aims at slowing down&#xD;
      myopia progression. The purpose of this study is to investigate if the MS lens can slow&#xD;
      myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly&#xD;
      assigned to either treatment group (wear MS lenses) or control group (wear ordinary single&#xD;
      vision lenses). Their cycloplegic refraction and axial length will be monitored every six&#xD;
      months over 2 years. The changes in refractive errors and axial length in two groups will be&#xD;
      compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cycloplegic Refraction Change in SER</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Axial Length</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Axial length (mm) was measured after cycloplegia using IOL Master</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Single vision spectacle lens</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Single vision lens with power for correcting distance refraction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple-Segment spectacle lens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multiple-Segment spectacle lens</intervention_name>
    <description>A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.</description>
    <arm_group_label>Multiple-Segment spectacle lens</arm_group_label>
    <other_name>MS lens</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age at enrolment: 8-13 year&#xD;
&#xD;
          -  Spherical equivalent refractions (SER): -1.00 to -5.00 Dioptres (D)&#xD;
&#xD;
          -  Astigmatism and anisometropia of 1.50 D or less&#xD;
&#xD;
          -  Spectacle corrected monocular logMAR visual acuity: 0 or better&#xD;
&#xD;
          -  Parents' understanding and acceptance of random allocation of grouping&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any ocular and systemic abnormalities might affect visual functions or refractive&#xD;
             development&#xD;
&#xD;
          -  prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition&#xD;
             lenses, bifocal lenses, drugs (e.g. atropine), etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carly SY Lam, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chi ho To, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Myopia Research, The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Myopia Research, The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
  </location_countries>
  <results_reference>
    <citation>Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.</citation>
    <PMID>31142465</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <results_first_submitted>May 16, 2018</results_first_submitted>
  <results_first_submitted_qc>June 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 31, 2019</results_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">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Carly Lam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 25, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT02206217/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Vision Spectacle Lens</title>
          <description>Single vision lens with power for correcting distance refraction.</description>
        </group>
        <group group_id="P2">
          <title>Multiple-Segment Spectacle Lens</title>
          <description>A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.&#xD;
Multiple-Segment spectacle lens: A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Vision Spectacle Lens</title>
          <description>Single vision lens with power for correcting distance refraction.</description>
        </group>
        <group group_id="B2">
          <title>Multiple-Segment Spectacle Lens</title>
          <description>A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.&#xD;
Multiple-Segment spectacle lens: A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="90"/>
            <count group_id="B2" value="93"/>
            <count group_id="B3" value="183"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.01" spread="1.44"/>
                    <measurement group_id="B2" value="10.19" spread="1.46"/>
                    <measurement group_id="B3" value="10.09" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hong Kong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>cycloplegic spherical equivalent refraction (SER)</title>
          <units>Diopters (D)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-2.69" spread="0.98"/>
                    <measurement group_id="B2" value="-2.92" spread="1.09"/>
                    <measurement group_id="B3" value="-2.81" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Axial length</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.62" spread="0.82"/>
                    <measurement group_id="B2" value="24.85" spread="1.59"/>
                    <measurement group_id="B3" value="24.74" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cycloplegic Refraction Change in SER</title>
        <description>Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>completed 2-year study</population>
        <group_list>
          <group group_id="O1">
            <title>SV Group</title>
            <description>single vision spectacle lens</description>
          </group>
          <group group_id="O2">
            <title>MS Group</title>
            <description>Multi-segment lens (or called DIMS lens)</description>
          </group>
        </group_list>
        <measure>
          <title>Cycloplegic Refraction Change in SER</title>
          <description>Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.</description>
          <population>completed 2-year study</population>
          <units>Diopters (D)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="0.58"/>
                    <measurement group_id="O2" value="-0.38" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Axial Length</title>
        <description>Axial length (mm) was measured after cycloplegia using IOL Master</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>completed 2-year study</population>
        <group_list>
          <group group_id="O1">
            <title>SV Group</title>
            <description>single vision spectacle lens</description>
          </group>
          <group group_id="O2">
            <title>MS Group</title>
            <description>Multi-segment lens (or called DIMS lens)</description>
          </group>
        </group_list>
        <measure>
          <title>Axial Length</title>
          <description>Axial length (mm) was measured after cycloplegia using IOL Master</description>
          <population>completed 2-year study</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0.24"/>
                    <measurement group_id="O2" value="0.21" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>Interventions were only spectacles, not drug or surgery. The subjects only wore spectacle lenses and had regular routine eye examination that the particpants rarely had risk of adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>SV Group</title>
          <description>single vision spectacle lens</description>
        </group>
        <group group_id="E2">
          <title>MS Group</title>
          <description>Multi-segment lens (or called DIMS lens)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Carly Sin Yin Lam</name_or_title>
      <organization>School of Optometry, The Hong Kong Polytechnic University</organization>
      <phone>2766 6091</phone>
      <email>carly.lam@polyu.edu.hk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02206217
org study id: H-ZG3B
nct id: NCT02206217
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can
      slow myopia progression in Hong Kong schoolchildren.

      MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens
MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal
      spectacle lens which corrects distance refractive error and at the same time produces myopic
      defocus images on the retina for all distances. The myopic defocus aims at slowing down
      myopia progression. The purpose of this study is to investigate if the MS lens can slow
      myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly
      assigned to either treatment group (wear MS lenses) or control group (wear ordinary single
      vision lenses). Their cycloplegic refraction and axial length will be monitored every six
      months over 2 years. The changes in refractive errors and axial length in two groups will be
      compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Cycloplegic Refraction Change in SER
time frame: Baseline and 2 years
description: Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
measure: Axial Length
time frame: Baseline and 2 years
description: Axial length (mm) was measured after cycloplegia using IOL Master
arm group label: Single vision spectacle lens
arm group type: No Intervention
description: Single vision lens with power for correcting distance refraction.
arm group label: Multiple-Segment spectacle lens
arm group type: Experimental
description: A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time.
intervention type: Device
intervention name: Multiple-Segment spectacle lens
description: A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.
arm group label: Multiple-Segment spectacle lens
other name: MS lens
criteria: 
gender: All
minimum age: 8 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carly SY Lam, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
last name: Chi ho To, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
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country: China
country: Hong Kong
citation: Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.
PMID: 31142465
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Carly Lam
investigator title: Professor
mesh term: Myopia
sharing ipd: No
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