<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/NCT03778086</url>
  </required_header>
  <id_info>
    <org_study_id>ACA_LZL_HZ</org_study_id>
    <nct_id>NCT03778086</nct_id>
  </id_info>
  <brief_title>Iridocorneal Angle and Anterior Segment Structure in Eyes of Children With Cataract</brief_title>
  <acronym>ACA</acronym>
  <official_title>Iridocorneal Angle and Anterior Segment Structure in Pediatric Cataract</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the morphology of iridocorneal angle and anterior&#xD;
      segment structure in children with cataract, and to explore potential preoperative structural&#xD;
      clues for postoperative glaucoma. The investigators included children with cataract planning&#xD;
      to have cataract surgery in our institute. For analysis, one eye was randomly selected in a&#xD;
      case of bilateral cataract via a random table, forming the &quot;bilateral cataract&quot; group; the&#xD;
      cataractous eyes in cases of unilateral cataract composed the &quot;unilateral cataract&quot; group and&#xD;
      the fellow non-cataractous eyes made up the &quot;control&quot; group. Exclusion criteria were: a&#xD;
      history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid&#xD;
      use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis,&#xD;
      persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma,&#xD;
      unable to complete examinations. The investigators recorded age at surgery, gender and&#xD;
      relevant ocular and systemic histories. All patients underwent slit lamp biomicroscopy,&#xD;
      dilated fundus examination and cycloplegic retinoscopy. In patients with good cooperation,&#xD;
      The investigators obtained the axial length (AL) using IOL-Master 500 and the intraocular&#xD;
      pressure (IOP) with a non-contact tonometer. In young patients with poor cooperation, the&#xD;
      investigators measured the AL with a contact A-scan, the central corneal thickness (CCD)&#xD;
      value with a handheld pachymeter and the IOP using a handheld tonometer under sedation. With&#xD;
      a contact A-scan, the AL measurement was repeated 10 times by the same examiner and the mean&#xD;
      value was analyzed. Corneal diameter was measured with a caliper in the operating room before&#xD;
      cataract surgery. Under general anesthesia, a pediatric surgeon (YEZ) evaluated the&#xD;
      iridocorneal angle with an indirect goniolens under the operating microscope. A gentle&#xD;
      tilting of the goniolens was allowed to obtain a better view of the angle. Another&#xD;
      experienced pediatric ophthalmologist (DDW) double checked the video recordings and graded&#xD;
      the details of iridocorneal angle according to the Shaffer and Spaeth classification system&#xD;
      and standard methods reported. The angle width was defined as follows: grade 0, a closed&#xD;
      angle without visible angle structures; grade 1, a very narrow angle with Schwalbe's line&#xD;
      visible only; grade 2, a moderately narrow angle with Schwalbe's line and trabecular meshwork&#xD;
      visible; grade 3, an open angle with trabecular meshwork and scleral spur visible; grade 4,&#xD;
      the widest angle with ciliary body band (CBB) visible. The iris insertion and pigmentation of&#xD;
      the posterior trabecular meshwork were classified according to the Spaeth classification&#xD;
      system. The iris insertion was defined as follows: A, anterior to Schwalbe's line; B, between&#xD;
      Schwalbe's line and scleral spur; C, scleral spur visible; D, deep with ciliary body visible;&#xD;
      E, extremely deep with &gt; 1 mm ciliary body band. The pigmentation of trabecular meshwork was&#xD;
      defined as follows: 0, no pigment; 1, minimal pigment; 2, mild pigment; 3, moderate pigment;&#xD;
      4, intense pigment. The number of iris process was defined as follows: 0, none; 1, minimal;&#xD;
      2, moderate; 3, marked. The width of CBB was graded according to the classification proposed&#xD;
      by Tawara et al and defined as follows: invisible, the CBB could not be seen at all; very&#xD;
      narrow, the CBB was narrower than the scleral spur; normal, the CBB was wider than the&#xD;
      scleral spur. The normality of variables was tested using Kolmogorov-Smirnov test. Continuous&#xD;
      variables are presented as mean±standard deviation or median (interquartile range) based on&#xD;
      the normality of variables, and categorical variables are presented as frequencies and&#xD;
      percentages. One-way ANOVA or Kruskal-Wallis test was used for overall comparison, and&#xD;
      Dunnett test or Kruskal-Wallis One-way ANOVA was used for paired-comparison of variables&#xD;
      between groups where appropriate. Mann-Whitney test was used for further subgroup comparison.&#xD;
      A P value less than 0.05 was considered statistically significant. All statistical analyses&#xD;
      were performed using SPSS version 21.0 (SPSS Inc, Chicago, Illinois, USA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Width of angle</measure>
    <time_frame>2016-06-01 to 2018-06-01</time_frame>
    <description>The angle width was defined as follows: grade 0, a closed angle without visible angle structures; grade 1, a very narrow angle with Schwalbe's line visible only; grade 2, a moderately narrow angle with Schwalbe's line and trabecular meshwork visible; grade 3, an open angle with trabecular meshwork and scleral spur visible; grade 4, the widest angle with ciliary body band (CBB) visible</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Width of ciliary body band</measure>
    <time_frame>2016-06-01 to 2018-06-01</time_frame>
    <description>The width of ciliary body band(CBB) is defined as follows: invisible, the CBB could not be seen at all; very narrow, the CBB is narrower than the scleral spur; normal, the CBB is wider than the scleral spur</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of iris processes</measure>
    <time_frame>2016-06-01 to 2018-06-01</time_frame>
    <description>The number of iris process is defined as follows: 0, none; 1, minimal; 2, moderate; 3, marked</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trabecular meshwork pigmentation</measure>
    <time_frame>2016-06-01 to 2018-06-01</time_frame>
    <description>The pigmentation of trabecular meshwork is defined as follows: 0, no pigment; 1, minimal pigment; 2, mild pigment</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Congenital Cataract</condition>
  <arm_group>
    <arm_group_label>cataractous eyes</arm_group_label>
    <description>eyes of children with unilateral or bilateral cataract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fellow eyes</arm_group_label>
    <description>fellow eyes of children with unilateral cataract</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>gonioscopy</intervention_name>
    <description>gonioscopic observation and grading of iridocorneal angle</description>
    <arm_group_label>cataractous eyes</arm_group_label>
    <arm_group_label>fellow eyes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants included eyes of children with unilateral or bilateral cataract.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with cataract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of ocular trauma&#xD;
&#xD;
          -  a history of intraocular surgery&#xD;
&#xD;
          -  preoperative glaucoma&#xD;
&#xD;
          -  steroid use before surgery&#xD;
&#xD;
          -  a history of maternal rubella syndrome&#xD;
&#xD;
          -  chronic anterior uveitis&#xD;
&#xD;
          -  persistent fetal vasculature&#xD;
&#xD;
          -  ocular anomalies associated with an increased risk of glaucoma&#xD;
&#xD;
          -  unable to complete examinations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Yune Zhao</investigator_full_name>
    <investigator_title>Director of Cataract Department</investigator_title>
  </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/NCT03778086
org study id: ACA_LZL_HZ
nct id: NCT03778086
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the morphology of iridocorneal angle and anterior
      segment structure in children with cataract, and to explore potential preoperative structural
      clues for postoperative glaucoma. The investigators included children with cataract planning
      to have cataract surgery in our institute. For analysis, one eye was randomly selected in a
      case of bilateral cataract via a random table, forming the "bilateral cataract" group; the
      cataractous eyes in cases of unilateral cataract composed the "unilateral cataract" group and
      the fellow non-cataractous eyes made up the "control" group. Exclusion criteria were: a
      history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid
      use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis,
      persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma,
      unable to complete examinations. The investigators recorded age at surgery, gender and
      relevant ocular and systemic histories. All patients underwent slit lamp biomicroscopy,
      dilated fundus examination and cycloplegic retinoscopy. In patients with good cooperation,
      The investigators obtained the axial length (AL) using IOL-Master 500 and the intraocular
      pressure (IOP) with a non-contact tonometer. In young patients with poor cooperation, the
      investigators measured the AL with a contact A-scan, the central corneal thickness (CCD)
      value with a handheld pachymeter and the IOP using a handheld tonometer under sedation. With
      a contact A-scan, the AL measurement was repeated 10 times by the same examiner and the mean
      value was analyzed. Corneal diameter was measured with a caliper in the operating room before
      cataract surgery. Under general anesthesia, a pediatric surgeon (YEZ) evaluated the
      iridocorneal angle with an indirect goniolens under the operating microscope. A gentle
      tilting of the goniolens was allowed to obtain a better view of the angle. Another
      experienced pediatric ophthalmologist (DDW) double checked the video recordings and graded
      the details of iridocorneal angle according to the Shaffer and Spaeth classification system
      and standard methods reported. The angle width was defined as follows: grade 0, a closed
      angle without visible angle structures; grade 1, a very narrow angle with Schwalbe's line
      visible only; grade 2, a moderately narrow angle with Schwalbe's line and trabecular meshwork
      visible; grade 3, an open angle with trabecular meshwork and scleral spur visible; grade 4,
      the widest angle with ciliary body band (CBB) visible. The iris insertion and pigmentation of
      the posterior trabecular meshwork were classified according to the Spaeth classification
      system. The iris insertion was defined as follows: A, anterior to Schwalbe's line; B, between
      Schwalbe's line and scleral spur; C, scleral spur visible; D, deep with ciliary body visible;
      E, extremely deep with > 1 mm ciliary body band. The pigmentation of trabecular meshwork was
      defined as follows: 0, no pigment; 1, minimal pigment; 2, mild pigment; 3, moderate pigment;
      4, intense pigment. The number of iris process was defined as follows: 0, none; 1, minimal;
      2, moderate; 3, marked. The width of CBB was graded according to the classification proposed
      by Tawara et al and defined as follows: invisible, the CBB could not be seen at all; very
      narrow, the CBB was narrower than the scleral spur; normal, the CBB was wider than the
      scleral spur. The normality of variables was tested using Kolmogorov-Smirnov test. Continuous
      variables are presented as mean±standard deviation or median (interquartile range) based on
      the normality of variables, and categorical variables are presented as frequencies and
      percentages. One-way ANOVA or Kruskal-Wallis test was used for overall comparison, and
      Dunnett test or Kruskal-Wallis One-way ANOVA was used for paired-comparison of variables
      between groups where appropriate. Mann-Whitney test was used for further subgroup comparison.
      A P value less than 0.05 was considered statistically significant. All statistical analyses
      were performed using SPSS version 21.0 (SPSS Inc, Chicago, Illinois, USA).
observational model: Cohort
time perspective: Prospective
measure: Width of angle
time frame: 2016-06-01 to 2018-06-01
description: The angle width was defined as follows: grade 0, a closed angle without visible angle structures; grade 1, a very narrow angle with Schwalbe's line visible only; grade 2, a moderately narrow angle with Schwalbe's line and trabecular meshwork visible; grade 3, an open angle with trabecular meshwork and scleral spur visible; grade 4, the widest angle with ciliary body band (CBB) visible
measure: Width of ciliary body band
time frame: 2016-06-01 to 2018-06-01
description: The width of ciliary body band(CBB) is defined as follows: invisible, the CBB could not be seen at all; very narrow, the CBB is narrower than the scleral spur; normal, the CBB is wider than the scleral spur
measure: The number of iris processes
time frame: 2016-06-01 to 2018-06-01
description: The number of iris process is defined as follows: 0, none; 1, minimal; 2, moderate; 3, marked
measure: Trabecular meshwork pigmentation
time frame: 2016-06-01 to 2018-06-01
description: The pigmentation of trabecular meshwork is defined as follows: 0, no pigment; 1, minimal pigment; 2, mild pigment
arm group label: cataractous eyes
description: eyes of children with unilateral or bilateral cataract
arm group label: fellow eyes
description: fellow eyes of children with unilateral cataract
intervention type: Procedure
intervention name: gonioscopy
description: gonioscopic observation and grading of iridocorneal angle
arm group label: cataractous eyes
arm group label: fellow eyes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 14 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Yune Zhao
investigator title: Director of Cataract Department
mesh term: Cataract
sharing ipd: Undecided