<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/NCT03260673</url>
  </required_header>
  <id_info>
    <org_study_id>17102</org_study_id>
    <nct_id>NCT03260673</nct_id>
  </id_info>
  <brief_title>Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus</brief_title>
  <official_title>白内障超声乳化术对2型糖尿病患者角膜内皮细胞的影响 Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tsinghua Chang Gung Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tsinghua Chang Gung Hospital</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 study investigate the change of the corneal endothelial cells in patients with type 2&#xD;
      diabetes after phacoemulsification with intraocular lens implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators do the clinical prospective study including 30 patients with type 2&#xD;
      diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. The&#xD;
      corneal endothelial cell density, variation in endothelial cell size (CV), percentage of&#xD;
      hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months&#xD;
      postoperatively.Then, the investigators compared the two sets of data. At last observing the&#xD;
      change of the corneal endothelial cells in patients with type 2 diabetes after&#xD;
      phacoemulsification with intraocular lens implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">July 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the corneal endothelial cell density before-after cataract surgery</measure>
    <time_frame>half year</time_frame>
    <description>Comparison of the corneal endothelial cell density before-after cataract surgery，the density is expressed in terms of the number of cells per square millimeter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the endothelial cell size before-after cataract surgery</measure>
    <time_frame>half year</time_frame>
    <description>Comparison of the endothelial cell size before-after cataract surgery，the size is measured in square microns.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the percentage of hexagonal cells before-after cataract surgery</measure>
    <time_frame>half year</time_frame>
    <description>Comparison of the percentage of hexagonal cells before-after cataract surgery,the percentage are expressed as &quot;%&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the central corneal thickness(CCT) before-after cataract surgery</measure>
    <time_frame>half year</time_frame>
    <description>Comparison of the central corneal thickness(CCT) before-after cataract surgery，the thickness is in microns.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Cataract</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>the diabetic group</arm_group_label>
    <description>patients with type 2 diabetes scheduled to undergo cataract surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the control group</arm_group_label>
    <description>patients without diabetes scheduled to undergo cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>specular microscope</intervention_name>
    <description>The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.</description>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_label>the diabetic group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Among the 60 patients enrolled in this study, the experimental group was 77.5 ±9.2 years&#xD;
        old, and the control age was 76.3±8.7 years, with no statistical difference (P = 0.87). All&#xD;
        patients were treated for 3 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        the experimental group:&#xD;
&#xD;
          1. Clinical diagnosis of cataract&#xD;
&#xD;
          2. Type 2 diabetes mellitus&#xD;
&#xD;
          3. The recent blood glucose control was stable&#xD;
&#xD;
          4. The glycosylated hemoglobin &lt; 8%&#xD;
&#xD;
        The control group:&#xD;
&#xD;
          1. Clinical diagnosis of cataract&#xD;
&#xD;
          2. No history of type 2 diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Corneal lesions&#xD;
&#xD;
          2. Anterior inflammation&#xD;
&#xD;
          3. Ocular trauma or surgical history&#xD;
&#xD;
          4. Glaucoma&#xD;
&#xD;
          5. Corneal endothelial cell density &lt; 1500 / mm squared&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>58 Years</minimum_age>
    <maximum_age>86 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cataract</keyword>
  <keyword>phacoemulsification</keyword>
  <keyword>type 2 diabetes mellitus</keyword>
  <keyword>corneal endothelial cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03260673
org study id: 17102
nct id: NCT03260673
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study investigate the change of the corneal endothelial cells in patients with type 2
      diabetes after phacoemulsification with intraocular lens implantation.
The investigators do the clinical prospective study including 30 patients with type 2
      diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. The
      corneal endothelial cell density, variation in endothelial cell size (CV), percentage of
      hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months
      postoperatively.Then, the investigators compared the two sets of data. At last observing the
      change of the corneal endothelial cells in patients with type 2 diabetes after
      phacoemulsification with intraocular lens implantation.
observational model: Case-Control
time perspective: Retrospective
measure: Comparison of the corneal endothelial cell density before-after cataract surgery
time frame: half year
description: Comparison of the corneal endothelial cell density before-after cataract surgery，the density is expressed in terms of the number of cells per square millimeter.
measure: Comparison of the endothelial cell size before-after cataract surgery
time frame: half year
description: Comparison of the endothelial cell size before-after cataract surgery，the size is measured in square microns.
measure: Comparison of the percentage of hexagonal cells before-after cataract surgery
time frame: half year
description: Comparison of the percentage of hexagonal cells before-after cataract surgery,the percentage are expressed as "%".
measure: Comparison of the central corneal thickness(CCT) before-after cataract surgery
time frame: half year
description: Comparison of the central corneal thickness(CCT) before-after cataract surgery，the thickness is in microns.
arm group label: the diabetic group
description: patients with type 2 diabetes scheduled to undergo cataract surgery
arm group label: the control group
description: patients without diabetes scheduled to undergo cataract surgery
intervention type: Other
intervention name: specular microscope
description: The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.
arm group label: the control group
arm group label: the diabetic group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 58 Years
maximum age: 86 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cataract
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes