<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/NCT03020056</url>
  </required_header>
  <id_info>
    <org_study_id>2016KYYJ007</org_study_id>
    <nct_id>NCT03020056</nct_id>
  </id_info>
  <brief_title>Impact of Cataract Surgery to Socioeconomic Status in Rural Area</brief_title>
  <acronym>ICSSES</acronym>
  <official_title>Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial to investigate the effect of cataract surgery on the&#xD;
      socioeconomic status of cataract patients in rural area of Southern China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cataract is the leading cause of visual impairment worldwide and surgery is the only&#xD;
      effective treatment. Previous studies show that visual impairment impacts the patient's&#xD;
      socioeconomic status(SES). However, how cataract surgery affects the SES of cataract patients&#xD;
      in rural area of China has not been determined before.&#xD;
&#xD;
      In the investigators study, cataract patients in rural area of Southern China will be&#xD;
      enrolled and randomly divided into two groups. Cataract surgery will be performed in 4 weeks&#xD;
      in intervention group, while performed at 1 year later in control group. The annual personal&#xD;
      income by work, annual household income, hours in paid and unpaid work in the previous month,&#xD;
      real estate ownership, household expenditures and quality of life will be investigated before&#xD;
      and 1 year after surgery. Then, the difference in SES and quality of life change between two&#xD;
      groups at 1 year later will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">June 29, 2018</completion_date>
  <primary_completion_date type="Actual">June 29, 2018</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>annual personal income by work in Chinese Yuan</measure>
    <time_frame>1 year</time_frame>
    <description>The annual personal income comprises of the direct and the indirect income by work. The indirect income is derived from unpaid work and calculated as follows: unpaid work time × local income per hour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life score</measure>
    <time_frame>1 year</time_frame>
    <description>Health-related QoL score will be measured by EuroQol 5 dimensions with 5 levels (EQ-5D-5L) and self-rated health (SRH). For each dimension, participants are asked to mark between 1: &quot;no problems&quot; to 5: &quot;unable to/extreme problems&quot;. Self-rated health using a vertical Visual Analogue Scale (VAS), with scores ranging from 0 (representing worst imaginable health state) to 100 (best imaginable health state).&#xD;
mobility&#xD;
self-care&#xD;
usual activities&#xD;
pain/discomfort&#xD;
anxiety/depression f: self-rated health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vision related quality of life score</measure>
    <time_frame>1 year</time_frame>
    <description>Vision related QoL score will be measured by Catquest-9S, which is a short form of Catquest questionnaire. The Catquest-9SF questionnaire comprises 7 questions for performing daily-life activities and 2 global questions about difficulties in general and satisfaction with vision (1= very great difficulty; 2= great difficulty; 3= some difficulty; 4= no difficulty).&#xD;
reading text in the newspaper&#xD;
recognizing faces of people you meet&#xD;
seeing prices of goods when shopping&#xD;
seeing to walk on uneven ground&#xD;
seeing to do needlework and handicraft&#xD;
reading text on television&#xD;
seeing to carry out a preferred hobby&#xD;
difficulty in daily life&#xD;
satisfaction on present vision</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">292</enrollment>
  <condition>Cataract Surgery</condition>
  <arm_group>
    <arm_group_label>waiting surgery</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>expedited surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cataract surgery will be performed within 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phacolin eye drops</intervention_name>
    <description>After enrollment, the participants will be provided antioxidant eye drops, Phacolin (Zhongshan ophthalmic center, China) for free.The eye drops will be administered 4 times per day for 1 year.Then either phacoemulsification or manual small incision cataract surgery will be performed.</description>
    <arm_group_label>waiting surgery</arm_group_label>
    <other_name>antioxidant eye drops</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cataract surgery</intervention_name>
    <description>After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.</description>
    <arm_group_label>expedited surgery</arm_group_label>
    <other_name>phacoemulsification or MSICS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age-related cataract patients aged over 50 with best corrected visual acuity (BCVA)&#xD;
             less than 0.3 in the better eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of other eye disease that contributes to visual impairment, including&#xD;
             keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.&#xD;
&#xD;
          -  Cases in need of expedited surgery, including shallow anterior chamber (central&#xD;
             anterior chamber depth less than 2 mm and/or peripheral anterior chamber depth less&#xD;
             than 1/4 corneal thickness), blindness of grade IV and V (BCVA less than 0.02 in the&#xD;
             better eye), and intumescent or hypermature stage of cortical cataract.&#xD;
&#xD;
          -  Systemic disease dampening activity, including cardiovascular and cerebrovascular&#xD;
             diseases, hemiplegia, neurodegenerative diseases such as Alzheimer's disease and&#xD;
             Parkinson's disease.&#xD;
&#xD;
          -  Patients not willing to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yizhi Liu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yingfeng Zheng, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Huidong people's hospital</name>
      <address>
        <city>Huidong</city>
        <state>Guangdong</state>
        <zip>516300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 26, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Yizhi Liu</investigator_full_name>
    <investigator_title>Clinical Professor,director of Zhongshan Ophthalmic Center</investigator_title>
  </responsible_party>
  <keyword>cataract surgery</keyword>
  <keyword>socioeconomic status</keyword>
  <keyword>quality of life</keyword>
  <keyword>rural area</keyword>
  <keyword>China</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Antioxidants</mesh_term>
  </intervention_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/NCT03020056
org study id: 2016KYYJ007
nct id: NCT03020056
lead sponsor: 
has dmc: Yes
This is a randomized controlled trial to investigate the effect of cataract surgery on the
      socioeconomic status of cataract patients in rural area of Southern China.
Cataract is the leading cause of visual impairment worldwide and surgery is the only
      effective treatment. Previous studies show that visual impairment impacts the patient's
      socioeconomic status(SES). However, how cataract surgery affects the SES of cataract patients
      in rural area of China has not been determined before.

      In the investigators study, cataract patients in rural area of Southern China will be
      enrolled and randomly divided into two groups. Cataract surgery will be performed in 4 weeks
      in intervention group, while performed at 1 year later in control group. The annual personal
      income by work, annual household income, hours in paid and unpaid work in the previous month,
      real estate ownership, household expenditures and quality of life will be investigated before
      and 1 year after surgery. Then, the difference in SES and quality of life change between two
      groups at 1 year later will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: annual personal income by work in Chinese Yuan
time frame: 1 year
description: The annual personal income comprises of the direct and the indirect income by work. The indirect income is derived from unpaid work and calculated as follows: unpaid work time × local income per hour.
measure: Health-related quality of life score
time frame: 1 year
description: Health-related QoL score will be measured by EuroQol 5 dimensions with 5 levels (EQ-5D-5L) and self-rated health (SRH). For each dimension, participants are asked to mark between 1: "no problems" to 5: "unable to/extreme problems". Self-rated health using a vertical Visual Analogue Scale (VAS), with scores ranging from 0 (representing worst imaginable health state) to 100 (best imaginable health state).
mobility
self-care
usual activities
pain/discomfort
anxiety/depression f: self-rated health
measure: Vision related quality of life score
time frame: 1 year
description: Vision related QoL score will be measured by Catquest-9S, which is a short form of Catquest questionnaire. The Catquest-9SF questionnaire comprises 7 questions for performing daily-life activities and 2 global questions about difficulties in general and satisfaction with vision (1= very great difficulty; 2= great difficulty; 3= some difficulty; 4= no difficulty).
reading text in the newspaper
recognizing faces of people you meet
seeing prices of goods when shopping
seeing to walk on uneven ground
seeing to do needlework and handicraft
reading text on television
seeing to carry out a preferred hobby
difficulty in daily life
satisfaction on present vision
arm group label: waiting surgery
arm group type: Placebo Comparator
description: Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China).
arm group label: expedited surgery
arm group type: Experimental
description: Cataract surgery will be performed within 4 weeks.
intervention type: Drug
intervention name: Phacolin eye drops
description: After enrollment, the participants will be provided antioxidant eye drops, Phacolin (Zhongshan ophthalmic center, China) for free.The eye drops will be administered 4 times per day for 1 year.Then either phacoemulsification or manual small incision cataract surgery will be performed.
arm group label: waiting surgery
other name: antioxidant eye drops
intervention type: Procedure
intervention name: cataract surgery
description: After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.
arm group label: expedited surgery
other name: phacoemulsification or MSICS
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Yizhi Liu, Doctor
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
last name: Yingfeng Zheng, Doctor
role: Study Director
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
investigator full name: Yizhi Liu
investigator title: Clinical Professor,director of Zhongshan Ophthalmic Center
mesh term: Cataract
mesh term: Ophthalmic Solutions
mesh term: Antioxidants
sharing ipd: Undecided