<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/NCT03230799</url>
  </required_header>
  <id_info>
    <org_study_id>CCPMOH2017-China-3</org_study_id>
    <nct_id>NCT03230799</nct_id>
  </id_info>
  <brief_title>Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery</brief_title>
  <official_title>Comparison of Minimal Invasive Lens Surgery and 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>
      Previously, we have developed a minimal invasive lens surgery in the purpose of reduce&#xD;
      post-operative complications of congenital cataract. This prospective, randomized controlled&#xD;
      study aims at comparing the prognosis of the minimal invasive lens surgery and the&#xD;
      traditional cataract surgery for treating congenital cataracts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with congenital cataract that requires surgical intervention are enrolled. Then the&#xD;
      patients are assigned to two groups: Group I: the participants receive a minimal invasive&#xD;
      lens surgery, while in Group II, the participants receive a traditional cataract surgery. A&#xD;
      secondary intraocular lens implantation is performed when the patient is two years old for&#xD;
      both Group I and Group II. Investigators then compare the visual acuity, incidence of high&#xD;
      intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil&#xD;
      abnormality between two groups, to evaluate and compare the prognosis of minimal invasive&#xD;
      lens surgery and traditional cataract surgery for treating congenital cataracts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</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>Best correctied visual acuity</measure>
    <time_frame>recorded at each follow-up to five years of age.</time_frame>
    <description>Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>High intra-ocular pressure</measure>
    <time_frame>after lens removal to five years of age.</time_frame>
    <description>Determined with Tono-Pen tonometer at each follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual axis opacification</measure>
    <time_frame>after lens removal to five years of age.</time_frame>
    <description>Determined with slit-lamp photography at each follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bi-ocular visual function</measure>
    <time_frame>performed when the patient is four years old and five years old.</time_frame>
    <description>Determined with synoptophore</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Congenital Cataract</condition>
  <arm_group>
    <arm_group_label>traditional cataract surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>minimal invasive lens surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>minimal invasive lens surgery</intervention_name>
    <description>We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we 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.</description>
    <arm_group_label>minimal invasive lens surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>traditional cataract surgery</intervention_name>
    <description>ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy</description>
    <arm_group_label>traditional cataract surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 1 month and 24 months&#xD;
&#xD;
          -  Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes&#xD;
             with an intact non-fibrotic capsular bag&#xD;
&#xD;
          -  Informed consent signed by a parent or legal guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  confirmed or suspected hereditary cataract, including and not restricted to family&#xD;
             history of congenital cataract&#xD;
&#xD;
          -  Intraocular pressure &gt;21 mmHg&#xD;
&#xD;
          -  Preterm birth (&lt;28 weeks)&#xD;
&#xD;
          -  Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or&#xD;
             systemic disease (congenital heart disease, ischemic encephalopathy)&#xD;
&#xD;
          -  History of ocular diseases (any congenital eye diseases, such as, congenital cataract,&#xD;
             congenital glaucoma, congenital aniridia) in the family&#xD;
&#xD;
          -  History of ocular trauma&#xD;
&#xD;
          -  Microcornea&#xD;
&#xD;
          -  Persistent hyperplastic primary vitreous&#xD;
&#xD;
          -  Rubella&#xD;
&#xD;
          -  Lowe syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yizhi Liu, 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 2022</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>May 10, 2022</last_update_submitted>
  <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</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>minimal invasive surgery</keyword>
  <keyword>secondary intraocular lens implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03230799
org study id: CCPMOH2017-China-3
nct id: NCT03230799
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Previously, we have developed a minimal invasive lens surgery in the purpose of reduce
      post-operative complications of congenital cataract. This prospective, randomized controlled
      study aims at comparing the prognosis of the minimal invasive lens surgery and the
      traditional cataract surgery for treating congenital cataracts.
Patients with congenital cataract that requires surgical intervention are enrolled. Then the
      patients are assigned to two groups: Group I: the participants receive a minimal invasive
      lens surgery, while in Group II, the participants receive a traditional cataract surgery. A
      secondary intraocular lens implantation is performed when the patient is two years old for
      both Group I and Group II. Investigators then compare the visual acuity, incidence of high
      intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil
      abnormality between two groups, to evaluate and compare the prognosis of minimal invasive
      lens surgery and traditional cataract surgery for treating congenital cataracts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Best correctied visual acuity
time frame: recorded at each follow-up to five years of age.
description: Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.
measure: High intra-ocular pressure
time frame: after lens removal to five years of age.
description: Determined with Tono-Pen tonometer at each follow-up
measure: Visual axis opacification
time frame: after lens removal to five years of age.
description: Determined with slit-lamp photography at each follow-up
measure: Bi-ocular visual function
time frame: performed when the patient is four years old and five years old.
description: Determined with synoptophore
arm group label: traditional cataract surgery
arm group type: Active Comparator
description: Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit)
arm group label: minimal invasive lens surgery
arm group type: Experimental
description: Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration
intervention type: Procedure
intervention name: minimal invasive lens surgery
description: We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we 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.
arm group label: minimal invasive lens surgery
intervention type: Procedure
intervention name: traditional cataract surgery
description: ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
arm group label: traditional cataract surgery
criteria: 
gender: All
minimum age: 1 Month
maximum age: 24 Months
healthy volunteers: No
last name: Yizhi Liu, 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
sharing ipd: No