<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/NCT03240796</url>
  </required_header>
  <id_info>
    <org_study_id>CCPMOH2017-China-4</org_study_id>
    <nct_id>NCT03240796</nct_id>
  </id_info>
  <brief_title>Secondary Intraocular Lens Implantation in Pediatric Patients</brief_title>
  <official_title>Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating 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>
      This prospective, non-randomized controlled study aiming at comparing the prognosis of&#xD;
      minimal invasive lens surgery and traditional cataract surgery for treating congenital&#xD;
      cataracts after the patient receives secondary intraocular artificial lens (IOL)&#xD;
      implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric patients received minimal invasive surgery and traditional lens removal surgery&#xD;
      (anterior capsulorhexis and irrigation/aspiration and posterior capsulorhexis and anterior&#xD;
      vitrectomy) are enrolled. The patients are assigned to two groups according to the strategy&#xD;
      of primary surgery: Group I: the participants received minimal invasive surgery, while in&#xD;
      Group II, the participants received a traditional cataract surgery. Investigators perform a&#xD;
      secondary intraocular lens implantation for the patients. Investigators compare the visual&#xD;
      acuity, incidence of high intraocular pressure, incidence of visual axis opacification,&#xD;
      uveitis and iris/pupil abnormality between two groups after the first and the second surgery,&#xD;
      aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract&#xD;
      surgery for treating congenital cataracts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Best corrected visual acuity</measure>
    <time_frame>recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)</time_frame>
    <description>measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual axis opacification</measure>
    <time_frame>recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)</time_frame>
    <description>Visual axis opacification was recorded by standardized slit lamp retroillumination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High intraocular pressure</measure>
    <time_frame>recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)</time_frame>
    <description>measured with Tono-pen tonometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bi-ocular visual function</measure>
    <time_frame>The examination is performed when the patient is four years old and older, once a year.</time_frame>
    <description>determined with synoptophore</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Congenital Cataract</condition>
  <arm_group>
    <arm_group_label>minimal invasive surgery and secondary IOL implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional cataract surgery and secondary IOL implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>minimal invasive surgery and secondary IOL implantation</intervention_name>
    <description>We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter and moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities. Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.</description>
    <arm_group_label>minimal invasive surgery and secondary IOL implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>traditional cataract surgery and secondary IOL implantation</intervention_name>
    <description>traditional cataract surgery: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit).&#xD;
Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.</description>
    <arm_group_label>traditional cataract surgery and secondary IOL implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age between 24 months and 72 months Uncomplicated congenital cataract and underwent&#xD;
        cataract removal Informed consent signed by a parent or legal guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intraocular pressure &gt;21 mmHg at enrollment Preterm birth (&lt;28 weeks) Presence of&#xD;
             other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic&#xD;
             disease (congenital heart disease, ischemic encephalopathy) History of ocular diseases&#xD;
             (any congenital eye diseases, such as, congenital cataract, congenital glaucoma,&#xD;
             congenital aniridia) in the family History of ocular trauma Microcornea Persistent&#xD;
             hyperplastic primary vitreous Rubella Lowe syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>72 Months</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>
  <overall_contact>
    <last_name>Jing Li, M.D</last_name>
    <phone>+86-20-87330341</phone>
    <email>Reviewborad_SYsU@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center,Sun Yat-sen U</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haotian Lin, Phd</last_name>
      <phone>+86-20-87330475</phone>
      <email>gddlht@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Haotian Lin, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yizhi Liu, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>April 9, 2019</last_update_submitted>
  <last_update_submitted_qc>April 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</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>congenital cataract</keyword>
  <keyword>intra-capsular IOL implantation</keyword>
  <keyword>ciliary sulcus fixation</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/NCT03240796
org study id: CCPMOH2017-China-4
nct id: NCT03240796
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This prospective, non-randomized controlled study aiming at comparing the prognosis of
      minimal invasive lens surgery and traditional cataract surgery for treating congenital
      cataracts after the patient receives secondary intraocular artificial lens (IOL)
      implantation.
Pediatric patients received minimal invasive surgery and traditional lens removal surgery
      (anterior capsulorhexis and irrigation/aspiration and posterior capsulorhexis and anterior
      vitrectomy) are enrolled. The patients are assigned to two groups according to the strategy
      of primary surgery: Group I: the participants received minimal invasive surgery, while in
      Group II, the participants received a traditional cataract surgery. Investigators perform a
      secondary intraocular lens implantation for the patients. Investigators compare the visual
      acuity, incidence of high intraocular pressure, incidence of visual axis opacification,
      uveitis and iris/pupil abnormality between two groups after the first and the second surgery,
      aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract
      surgery for treating congenital cataracts.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Best corrected visual acuity
time frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
description: measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.
measure: Visual axis opacification
time frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
description: Visual axis opacification was recorded by standardized slit lamp retroillumination.
measure: High intraocular pressure
time frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
description: measured with Tono-pen tonometer
measure: Bi-ocular visual function
time frame: The examination is performed when the patient is four years old and older, once a year.
description: determined with synoptophore
arm group label: minimal invasive surgery and secondary IOL implantation
arm group type: Experimental
arm group label: traditional cataract surgery and secondary IOL implantation
arm group type: Active Comparator
intervention type: Procedure
intervention name: minimal invasive surgery and secondary IOL implantation
description: We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter and moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities. Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.
arm group label: minimal invasive surgery and secondary IOL implantation
intervention type: Procedure
intervention name: traditional cataract surgery and secondary IOL implantation
description: traditional cataract surgery: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit).
Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.
arm group label: traditional cataract surgery and secondary IOL implantation
criteria: 
gender: All
minimum age: 24 Months
maximum age: 72 Months
healthy volunteers: No
last name: Haotian Lin, M.D,Ph.D
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
last name: Jing Li, M.D
phone: +86-20-87330341
email: Reviewborad_SYsU@163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
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