<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/NCT04499768</url>
  </required_header>
  <id_info>
    <org_study_id>2018ZY14</org_study_id>
    <nct_id>NCT04499768</nct_id>
  </id_info>
  <brief_title>A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy</brief_title>
  <official_title>A Longitudinal Study of Choroidal Changes Assessed With Swept-source Optical Coherence Tomography After Cataract Surgery in Eyes With Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</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>
      To determine the influence of phacoemulsification on choroidal vasculature in patients with&#xD;
      diabetic retinopathy (DR) undergoing cataract surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine the influence of phacoemulsification on choroidal vasculature in patients with&#xD;
      diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal&#xD;
      thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence&#xD;
      tomography (SS-OCT) system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CVI at baseline</measure>
    <time_frame>CVI was assessed at baseline(within 1 week before surgery)</time_frame>
    <description>choroidal vascularity index(CVI) was defined as the proportion of vascular area to total circumscribed area.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CVI at 1 week postoperatively</measure>
    <time_frame>CVI was assessed 1 week after surgery.</time_frame>
    <description>choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CVI at 1 month postoperatively</measure>
    <time_frame>CVI was assessed 1 month after surgery.</time_frame>
    <description>choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CVI at 3 months postoperatively</measure>
    <time_frame>CVI was assessed 3 months after surgery.</time_frame>
    <description>choroidal vascularity index (CVI)was defined as the proportion of vascular area to total circumscribed area.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CT at baseline</measure>
    <time_frame>CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.</time_frame>
    <description>Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CT at 1 week postoperatively</measure>
    <time_frame>CT was assessed at 1 week after surgery.</time_frame>
    <description>Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CT at 1 month postoperatively</measure>
    <time_frame>CT was assessed at 1 month after surgery.</time_frame>
    <description>Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CT at 3 months postoperatively</measure>
    <time_frame>CT was assessed at 3 months after surgery.</time_frame>
    <description>Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VD at baseline</measure>
    <time_frame>VD of the choriocapillaris was assessed at baseline.</time_frame>
    <description>VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VD at 1 week postoperatively</measure>
    <time_frame>VD of the choriocapillaris was assessed 1 week after surgery.</time_frame>
    <description>VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VD at 1 month postoperatively</measure>
    <time_frame>VD of the choriocapillaris was assessed 1 month after surgery.</time_frame>
    <description>VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VD at 3 months postoperatively</measure>
    <time_frame>VD of the choriocapillaris was assessed 3 months after surgery.</time_frame>
    <description>VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IOP at baseline</measure>
    <time_frame>IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.</time_frame>
    <description>IOP was the value of intraocular pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOP at 1 week postoperatively</measure>
    <time_frame>IOP was assessed 1 week after surgery.</time_frame>
    <description>IOP was the value of intraocular pressure .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOP at 1 month postoperatively</measure>
    <time_frame>IOP was assessed 1 month after surgery.</time_frame>
    <description>IOP was the value of intraocular pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOP at 3 months postoperatively</measure>
    <time_frame>IOP was assessed 3 months after surgery.</time_frame>
    <description>IOP was the value of intraocular pressure .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BCVA at baseline</measure>
    <time_frame>BCVA was assessed at baseline .</time_frame>
    <description>BCVA was the best corrected visual acuity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BCVA at 3 months postoperatively</measure>
    <time_frame>BCVA was assessed 3 months after surgery.</time_frame>
    <description>BCVA was the best corrected visual acuity.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Optical Coherence Tomography</condition>
  <condition>Diabetic Retinopathy</condition>
  <condition>Choroid</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>the age-related cataract patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DR group</arm_group_label>
    <description>the cataract patients with mild/moderate NPDR</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        23 eyes of 23 cataract patients with mild/moderate NPDR without DME, and 23 age-matched&#xD;
        non-diabetic patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged⩾40years; intraocular pressure (IOP) &lt; 21 mm Hg in both eyes, spherical refractive&#xD;
             error&lt;6 diopters spherical equivalent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous retinal surgery, glaucoma, uveitis, age-related macular degeneration,&#xD;
             arterial or vein occlusions, macular hole, or other ocular diseases that could&#xD;
             interfere the CT and/or CVI measurement, severe systemic diseases, such as&#xD;
             uncontrolled hypertension, obstructive sleep apnea, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Xi Shen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Xi Shen</investigator_full_name>
    <investigator_title>chief physician</investigator_title>
  </responsible_party>
  <keyword>Diabetic choroidopathy</keyword>
  <keyword>Diabetic retinopathy</keyword>
  <keyword>choroidal vascularity index</keyword>
  <keyword>choroidal thickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Capsule Opacification</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/NCT04499768
org study id: 2018ZY14
nct id: NCT04499768
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To determine the influence of phacoemulsification on choroidal vasculature in patients with
      diabetic retinopathy (DR) undergoing cataract surgery
To determine the influence of phacoemulsification on choroidal vasculature in patients with
      diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal
      thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence
      tomography (SS-OCT) system.
observational model: Case-Control
time perspective: Prospective
measure: CVI at baseline
time frame: CVI was assessed at baseline(within 1 week before surgery)
description: choroidal vascularity index(CVI) was defined as the proportion of vascular area to total circumscribed area.
measure: CVI at 1 week postoperatively
time frame: CVI was assessed 1 week after surgery.
description: choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.
measure: CVI at 1 month postoperatively
time frame: CVI was assessed 1 month after surgery.
description: choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.
measure: CVI at 3 months postoperatively
time frame: CVI was assessed 3 months after surgery.
description: choroidal vascularity index (CVI)was defined as the proportion of vascular area to total circumscribed area.
measure: CT at baseline
time frame: CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.
description: Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
measure: CT at 1 week postoperatively
time frame: CT was assessed at 1 week after surgery.
description: Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
measure: CT at 1 month postoperatively
time frame: CT was assessed at 1 month after surgery.
description: Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
measure: CT at 3 months postoperatively
time frame: CT was assessed at 3 months after surgery.
description: Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device.
measure: VD at baseline
time frame: VD of the choriocapillaris was assessed at baseline.
description: VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
measure: VD at 1 week postoperatively
time frame: VD of the choriocapillaris was assessed 1 week after surgery.
description: VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
measure: VD at 1 month postoperatively
time frame: VD of the choriocapillaris was assessed 1 month after surgery.
description: VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
measure: VD at 3 months postoperatively
time frame: VD of the choriocapillaris was assessed 3 months after surgery.
description: VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid
measure: IOP at baseline
time frame: IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
description: IOP was the value of intraocular pressure.
measure: IOP at 1 week postoperatively
time frame: IOP was assessed 1 week after surgery.
description: IOP was the value of intraocular pressure .
measure: IOP at 1 month postoperatively
time frame: IOP was assessed 1 month after surgery.
description: IOP was the value of intraocular pressure.
measure: IOP at 3 months postoperatively
time frame: IOP was assessed 3 months after surgery.
description: IOP was the value of intraocular pressure .
measure: BCVA at baseline
time frame: BCVA was assessed at baseline .
description: BCVA was the best corrected visual acuity.
measure: BCVA at 3 months postoperatively
time frame: BCVA was assessed 3 months after surgery.
description: BCVA was the best corrected visual acuity.
arm group label: control
description: the age-related cataract patients
arm group label: DR group
description: the cataract patients with mild/moderate NPDR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
last name: Xi Shen, PhD
role: Study Director
affiliation: Shanghai Jiao Tong University School of Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Xi Shen
investigator title: chief physician
mesh term: Cataract
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Capsule Opacification