<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/NCT02966496</url>
  </required_header>
  <id_info>
    <org_study_id>QinghaiUH_005</org_study_id>
    <nct_id>NCT02966496</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Implantation of Two Multifocal Intraocular Lenses in the Treatment of Senile Cataract</brief_title>
  <official_title>Safety and Efficacy of Implantation of Two Multifocal Intraocular Lenses in the Treatment of Senile Cataract: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qinghai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qinghai University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is designed to compare the biocompatibility and long-term visual outcomes of the&#xD;
      Tecnis Z9001 and Acri.LISA 366D multifocal IOLs used for the treatment of senile cataract.&#xD;
      The aim is to provide a safer biomaterial for senile cataract treatment, achieving better&#xD;
      postoperative visual quality and fewer complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      History and current studies Aging-induced degenerative diseases are the leading cause of&#xD;
      senile cataract. Phacoemulsification with intraocular lens (IOL) implantation is a commonly&#xD;
      employed surgical technique for the treatment of cataract. A traditional IOL is spherical and&#xD;
      monofocal. Traditional monofocal IOL implantation allows cataract patients to obtain good&#xD;
      postoperative distance vision but loss of accommodation results in poor near vision.&#xD;
      Following monofocal IOL implantation, most patients still require the use of glasses.&#xD;
      Fortunately, the presence of multifocal IOLs solves this problem. Studies have shown that&#xD;
      aspheric IOLs with zero or negative spherical aberration can eliminate or reduce the&#xD;
      spherical aberration of the whole eye and can improve contrast sensitivity and night vision&#xD;
      compared with a spherical IOL.&#xD;
&#xD;
      As first reported in 1987 by Keatea et al., multifocal IOLs were introduced to provide&#xD;
      improved visual acuity, thus eliminating the need to wear glasses and improving the patient's&#xD;
      quality of life. Increasing evidence-based medicine evidences have shown that multifocal IOLs&#xD;
      are more adept to improving near vision than single-focus IOLs. To date, various types of&#xD;
      multifocal IOLs have been developed and according to different design principles, clinically&#xD;
      used multifocal IOLs have been divided into refraction type, diffraction type and&#xD;
      refraction/diffraction type. Introduced in 2002, the Tecnis Z9001 diffractive multifocal&#xD;
      aspherical IOL (Abbott Medical Optics, CA, USA) is clinically proven to give patients&#xD;
      improved contrast vision and visual quality when compared with the common IOL, although&#xD;
      deficiencies include postoperative glare and reduced contrast sensitivity. Emerging designs&#xD;
      for multifocal IOLs aim to provide improvements in postoperative visual quality. The&#xD;
      Acri.LISA 366D multifocal aspheric IOL is a relatively novel refractive/diffractive&#xD;
      multifocal IOL that is different from traditional IOLs. Its unique optical design improves&#xD;
      the patient's full vision and reduces the incidence of light scattering, glare and halo,&#xD;
      which is expected to deliver better clinical outcomes. However, its long-term clinical&#xD;
      performance and the potential incidence of complications still need further evaluation.&#xD;
&#xD;
      It is worth noting that as age increases, the increase in presbyopia, aberrations and lens&#xD;
      scattering reduces the compensation for corneal aberrations, thereby resulting in a decrease&#xD;
      in visual acuity and contrast sensitivity. Given this, ideal IOLs should have good&#xD;
      biocompatibility and good resolution with no spherical aberration.&#xD;
&#xD;
      Data collection, management, analysis, and open access Data collection Clinical data will be&#xD;
      collected and managed using an electronic data capture system. All data relevant to the trial&#xD;
      will be recorded in electronic case report forms that will be provided by the sponsor&#xD;
      personnel. The case report will be completed after the interview.&#xD;
&#xD;
      Data management After completion of follow-up and data confirmation, only the project manager&#xD;
      will lock the database. The locked data will be unable to be altered and will be preserved&#xD;
      for future reference by the Affiliated Hospital of Qinghai University in China.&#xD;
&#xD;
      Data analysis All data will be statistically analyzed by professional statisticians.&#xD;
&#xD;
      Open data Published data will be released at http://www.medresman.org.&#xD;
&#xD;
      Statistical analysis All data will be statistically analyzed by statisticians using SPSS&#xD;
      v19.0 software. Normally distributed measurement data will be expressed as mean ± standard&#xD;
      deviation, while non-normally distributed data will be expressed as quartiles and medians.&#xD;
      Categorical variables will be expressed as counts and percentages. Two-sample t-test or&#xD;
      Mann-Whitney U-test will be used for intergroup comparison of visual acuity and diopter. The&#xD;
      chi-squared test or Fisher's exact test will be used for intergroup comparison of incidence&#xD;
      of histocompatibility reactions between the implant and host tissues and the percentage of&#xD;
      complications. A value of P &lt; O.05 will be considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">June 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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cataract participants with good biocompatibility of intraocular lens implants</measure>
    <time_frame>month 12 after surgery</time_frame>
    <description>Good engraftment, epithelialization, no neovascularization, retained transparency, no host inflammatory reaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>at month 1, month 3, month 6, month 12 and month 24 after surgery</time_frame>
    <description>Best spectacle corrected visual acuity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Senile Cataract</condition>
  <arm_group>
    <arm_group_label>the test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients aged 50-80 years will be randomly assigned to implantation of Acri.LISA366D multifocal aspheric IOLs in the test group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients aged 50-80 years will be randomly assigned to implantation of TecnisZ9001 multifocal aspheric IOLs in the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Acri.LISA366D multifocal aspheric IOLs</intervention_name>
    <description>The implantation of Acri.LISA366D multifocal aspheric IOLs are used in the test group.</description>
    <arm_group_label>the test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TecnisZ9001 multifocal aspheric IOLs</intervention_name>
    <description>The implantation of TecnisZ9001 multifocal aspheric IOLs are used in the test group.</description>
    <arm_group_label>the control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed as age-related cataract.&#xD;
&#xD;
          -  Corneal astigmatism &lt; 1.0 D&#xD;
&#xD;
          -  Lens hardness, II-III&#xD;
&#xD;
          -  Initial surgery on the eye&#xD;
&#xD;
          -  Age 50-80 years&#xD;
&#xD;
          -  Healthy and able to tolerate anesthesia and surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glaucoma or secondary vision loss resulting from diabetes, hypertension, intracranial&#xD;
             tumors and neurological diseases&#xD;
&#xD;
          -  Fundus disease, corneal edema, corneal opacity, endophthalmitis, and/or iris adhesion.&#xD;
&#xD;
          -  Prior experience of eye surgery&#xD;
&#xD;
          -  Failure to make regular referrals&#xD;
&#xD;
          -  Autoimmune disease, mental illness or other serious systemic disease&#xD;
&#xD;
          -  Inability to cooperate with the researchers&#xD;
&#xD;
          -  Inability to tolerate surgery&#xD;
&#xD;
          -  Sensitivity, anxiety or the pursuit of perfection&#xD;
&#xD;
          -  Inability to give informed consent&#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>Ping Yu, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Qinghai University</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 14, 2016</last_update_submitted>
  <last_update_submitted_qc>November 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02966496
org study id: QinghaiUH_005
nct id: NCT02966496
lead sponsor: 
has dmc: Yes
This trial is designed to compare the biocompatibility and long-term visual outcomes of the
      Tecnis Z9001 and Acri.LISA 366D multifocal IOLs used for the treatment of senile cataract.
      The aim is to provide a safer biomaterial for senile cataract treatment, achieving better
      postoperative visual quality and fewer complications.
History and current studies Aging-induced degenerative diseases are the leading cause of
      senile cataract. Phacoemulsification with intraocular lens (IOL) implantation is a commonly
      employed surgical technique for the treatment of cataract. A traditional IOL is spherical and
      monofocal. Traditional monofocal IOL implantation allows cataract patients to obtain good
      postoperative distance vision but loss of accommodation results in poor near vision.
      Following monofocal IOL implantation, most patients still require the use of glasses.
      Fortunately, the presence of multifocal IOLs solves this problem. Studies have shown that
      aspheric IOLs with zero or negative spherical aberration can eliminate or reduce the
      spherical aberration of the whole eye and can improve contrast sensitivity and night vision
      compared with a spherical IOL.

      As first reported in 1987 by Keatea et al., multifocal IOLs were introduced to provide
      improved visual acuity, thus eliminating the need to wear glasses and improving the patient's
      quality of life. Increasing evidence-based medicine evidences have shown that multifocal IOLs
      are more adept to improving near vision than single-focus IOLs. To date, various types of
      multifocal IOLs have been developed and according to different design principles, clinically
      used multifocal IOLs have been divided into refraction type, diffraction type and
      refraction/diffraction type. Introduced in 2002, the Tecnis Z9001 diffractive multifocal
      aspherical IOL (Abbott Medical Optics, CA, USA) is clinically proven to give patients
      improved contrast vision and visual quality when compared with the common IOL, although
      deficiencies include postoperative glare and reduced contrast sensitivity. Emerging designs
      for multifocal IOLs aim to provide improvements in postoperative visual quality. The
      Acri.LISA 366D multifocal aspheric IOL is a relatively novel refractive/diffractive
      multifocal IOL that is different from traditional IOLs. Its unique optical design improves
      the patient's full vision and reduces the incidence of light scattering, glare and halo,
      which is expected to deliver better clinical outcomes. However, its long-term clinical
      performance and the potential incidence of complications still need further evaluation.

      It is worth noting that as age increases, the increase in presbyopia, aberrations and lens
      scattering reduces the compensation for corneal aberrations, thereby resulting in a decrease
      in visual acuity and contrast sensitivity. Given this, ideal IOLs should have good
      biocompatibility and good resolution with no spherical aberration.

      Data collection, management, analysis, and open access Data collection Clinical data will be
      collected and managed using an electronic data capture system. All data relevant to the trial
      will be recorded in electronic case report forms that will be provided by the sponsor
      personnel. The case report will be completed after the interview.

      Data management After completion of follow-up and data confirmation, only the project manager
      will lock the database. The locked data will be unable to be altered and will be preserved
      for future reference by the Affiliated Hospital of Qinghai University in China.

      Data analysis All data will be statistically analyzed by professional statisticians.

      Open data Published data will be released at http://www.medresman.org.

      Statistical analysis All data will be statistically analyzed by statisticians using SPSS
      v19.0 software. Normally distributed measurement data will be expressed as mean ± standard
      deviation, while non-normally distributed data will be expressed as quartiles and medians.
      Categorical variables will be expressed as counts and percentages. Two-sample t-test or
      Mann-Whitney U-test will be used for intergroup comparison of visual acuity and diopter. The
      chi-squared test or Fisher's exact test will be used for intergroup comparison of incidence
      of histocompatibility reactions between the implant and host tissues and the percentage of
      complications. A value of P < O.05 will be considered statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of cataract participants with good biocompatibility of intraocular lens implants
time frame: month 12 after surgery
description: Good engraftment, epithelialization, no neovascularization, retained transparency, no host inflammatory reaction.
measure: Visual acuity
time frame: at month 1, month 3, month 6, month 12 and month 24 after surgery
description: Best spectacle corrected visual acuity
arm group label: the test group
arm group type: Experimental
description: The patients aged 50-80 years will be randomly assigned to implantation of Acri.LISA366D multifocal aspheric IOLs in the test group.
arm group label: the control group
arm group type: Experimental
description: The patients aged 50-80 years will be randomly assigned to implantation of TecnisZ9001 multifocal aspheric IOLs in the control group.
intervention type: Biological
intervention name: Acri.LISA366D multifocal aspheric IOLs
description: The implantation of Acri.LISA366D multifocal aspheric IOLs are used in the test group.
arm group label: the test group
intervention type: Biological
intervention name: TecnisZ9001 multifocal aspheric IOLs
description: The implantation of TecnisZ9001 multifocal aspheric IOLs are used in the test group.
arm group label: the control group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ping Yu, Master
role: Principal Investigator
affiliation: Affiliated Hospital of Qinghai University
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: Undecided