<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/NCT02234635</url>
  </required_header>
  <id_info>
    <org_study_id>VQIOL-21</org_study_id>
    <nct_id>NCT02234635</nct_id>
  </id_info>
  <brief_title>Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens After Cataract Surgery</brief_title>
  <official_title>Phase 1 Evaluate the Visual Quality Change of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses; Phase 2 Evaluate the Tear Film Quality Dynamics of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators examined the subjective visual quality including LogMAR&#xD;
      uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity&#xD;
      (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate&#xD;
      visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual&#xD;
      acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including&#xD;
      Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS&#xD;
      value (OV),and the tear-film quality dynamics including the tear break-up time and the&#xD;
      tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality&#xD;
      analysis system (OQAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 eyes of 50 cataract patients scheduled for phacoemulsification surgery were recruited, the&#xD;
      multifocal group (25 eyes) ，were implantation with Tecnis® ZMB00；and the monofocal group (25&#xD;
      eyes) were implantation with Tecnis® ZCB00.&#xD;
&#xD;
      Methods: All eyes were examined by logMAR visual acuity chart and Optical quality analysis&#xD;
      system (OQAS) at 1 week, 1 month, 3 month, 6 month,12 month after surgery for the subjective&#xD;
      and objective visual quality Change during the first year.&#xD;
&#xD;
      Measures:Subjective and objective visual quality were evaluated.Tear-film quality&#xD;
      dynamicswere evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens</measure>
    <time_frame>1week, 1month, 3month,6month,12month</time_frame>
    <description>Visual quality change during the first year after cataract surgery. The visual quality including the subjective and objective visual quality. The subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) and distance corrected near visual acuity (DCNVA).&#xD;
The objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI) and OQAS value (OV).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens</measure>
    <time_frame>1week, 1month, 3month,6month,12month</time_frame>
    <description>The tear-film quality dynamics including the tear break-up time and the tear-film OSI were examined by optical quality analysis system (OQAS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Dry Eye</condition>
  <condition>Vision Disorders</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>monofocal IOLs group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>monofocal IOLs group were implantation with Tecnis® ZCB00</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diffractive multifocal IOLs group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diffractive multifocal IOLs group</intervention_name>
    <description>Diffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity.</description>
    <arm_group_label>Diffractive multifocal IOLs group</arm_group_label>
    <arm_group_label>monofocal IOLs group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eyes with an axial length of 22.00 to 25.00 mm with age-related cataract.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative exclusion criteria included diabetes, history of ocular surgery or&#xD;
             inflammation.&#xD;
&#xD;
          -  Patients who could not be available for follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fang Yu</last_name>
    <role>Study Director</role>
    <affiliation>Affiliated Eye Hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fang Yu</last_name>
    <phone>13758452287</phone>
    <email>357574103@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fang, Yu</last_name>
      <phone>13758452287</phone>
      <email>357574103@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>yin ying zhao</investigator_full_name>
    <investigator_title>doctor of ophthalmology, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>visual acuity</keyword>
  <keyword>objective visual quality</keyword>
  <keyword>multifocal intraocular lens</keyword>
  <keyword>tear-film quality dynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision Disorders</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/NCT02234635
org study id: VQIOL-21
nct id: NCT02234635
lead sponsor: 
has dmc: Yes
In this study, the investigators examined the subjective visual quality including LogMAR
      uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity
      (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate
      visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual
      acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including
      Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS
      value (OV),and the tear-film quality dynamics including the tear break-up time and the
      tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality
      analysis system (OQAS).
50 eyes of 50 cataract patients scheduled for phacoemulsification surgery were recruited, the
      multifocal group (25 eyes) ，were implantation with Tecnis® ZMB00；and the monofocal group (25
      eyes) were implantation with Tecnis® ZCB00.

      Methods: All eyes were examined by logMAR visual acuity chart and Optical quality analysis
      system (OQAS) at 1 week, 1 month, 3 month, 6 month,12 month after surgery for the subjective
      and objective visual quality Change during the first year.

      Measures:Subjective and objective visual quality were evaluated.Tear-film quality
      dynamicswere evaluated.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens
time frame: 1week, 1month, 3month,6month,12month
description: Visual quality change during the first year after cataract surgery. The visual quality including the subjective and objective visual quality. The subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) and distance corrected near visual acuity (DCNVA).
The objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI) and OQAS value (OV).
measure: To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens
time frame: 1week, 1month, 3month,6month,12month
description: The tear-film quality dynamics including the tear break-up time and the tear-film OSI were examined by optical quality analysis system (OQAS)
arm group label: monofocal IOLs group
arm group type: Other
description: monofocal IOLs group were implantation with Tecnis® ZCB00
arm group label: Diffractive multifocal IOLs group
arm group type: Active Comparator
description: Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00
intervention type: Other
intervention name: Diffractive multifocal IOLs group
description: Diffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity.
arm group label: Diffractive multifocal IOLs group
arm group label: monofocal IOLs group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Fang Yu
role: Study Director
affiliation: Affiliated Eye Hospital of Wenzhou Medical University
last name: Fang Yu
phone: 13758452287
email: 357574103@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: yin ying zhao
investigator title: doctor of ophthalmology, Principal Investigator, Clinical Professor
mesh term: Vision Disorders