<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/NCT01726569</url>
  </required_header>
  <id_info>
    <org_study_id>ZOC-CREST1</org_study_id>
    <nct_id>NCT01726569</nct_id>
  </id_info>
  <brief_title>Post-operative Satisfaction With Glaucoma Surgery Trial</brief_title>
  <official_title>A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With Glaucoma Surgery in Rural China</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Investigate degree of postoperative satisfaction in county level hospital glaucoma&#xD;
           patients.&#xD;
&#xD;
        2. Investigate the effect of educational intervention affect the degree of satisfaction in&#xD;
           glaucoma patients.&#xD;
&#xD;
        3. Investigate the effect factors of postoperative satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glaucoma is the leading cause irreversible blindness worldwide, but only less than 10%&#xD;
      glaucoma patients were diagnosed in the country of Asia areas. In the country of China,&#xD;
      patients who are low educational level and less known acknowledgement and information have&#xD;
      less known glaucoma. In the help of the government and some international non-governmental&#xD;
      organizations(NGOs), a lot of people in the country know the cataract, and the operability of&#xD;
      cataract is increase. Because vision loss usually development after operation for glaucoma.&#xD;
      If patients did not understand this, they may be not only do not accept operation, but also&#xD;
      affect operability of cataract. We hope the educational intervention for glaucoma can&#xD;
      increase the degree of satisfaction in glaucoma patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study sites were reconsidered.&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">March 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative satisfaction rate in both group</measure>
    <time_frame>after surgery up to 6 weeks</time_frame>
    <description>the rate of satisfaction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>knowledge about glaucoma</measure>
    <time_frame>before surgery and after surgey 1 week and 6 weeks</time_frame>
    <description>the knowledge about glaucoma scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>willingness to recommend surgery</measure>
    <time_frame>after surgery 1 week and 6 weeks</time_frame>
    <description>The rate of willingness to recommend surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>personality in both groups</measure>
    <time_frame>Baseline (before surgery)</time_frame>
    <description>use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ_RSC) access glaucoma patients personality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraocular pressure and visual acuity in both groups</measure>
    <time_frame>before surgery and after surgery 1week and 6 weeks</time_frame>
    <description>intraocular pressure and visual acuity in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>film and trained counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session and follow up counseling after operation 1 week and 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>film and trained counseling</intervention_name>
    <description>Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session.</description>
    <arm_group_label>film and trained counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional counseling</intervention_name>
    <description>Subjects will be not participate or participate in a pre-operative/post-operative counseling session with a rural hospital's doctor/nurse as usual traditional methods.</description>
    <arm_group_label>film and trained counseling</arm_group_label>
    <arm_group_label>traditional counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and&#xD;
             dysgnosia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Congdon, MD,MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>December 5, 2021</last_update_submitted>
  <last_update_submitted_qc>December 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Congdon Nathan</investigator_full_name>
    <investigator_title>Guangdong Educational Intervention for Rural Glaucoma surgical patient</investigator_title>
  </responsible_party>
  <keyword>glaucoma</keyword>
  <keyword>educational intervention</keyword>
  <keyword>post-operative satisfaction</keyword>
  <keyword>knowledges</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT01726569
org study id: ZOC-CREST1
nct id: NCT01726569
lead sponsor: 
has dmc: Yes
1. Investigate degree of postoperative satisfaction in county level hospital glaucoma
           patients.

        2. Investigate the effect of educational intervention affect the degree of satisfaction in
           glaucoma patients.

        3. Investigate the effect factors of postoperative satisfaction.
Glaucoma is the leading cause irreversible blindness worldwide, but only less than 10%
      glaucoma patients were diagnosed in the country of Asia areas. In the country of China,
      patients who are low educational level and less known acknowledgement and information have
      less known glaucoma. In the help of the government and some international non-governmental
      organizations(NGOs), a lot of people in the country know the cataract, and the operability of
      cataract is increase. Because vision loss usually development after operation for glaucoma.
      If patients did not understand this, they may be not only do not accept operation, but also
      affect operability of cataract. We hope the educational intervention for glaucoma can
      increase the degree of satisfaction in glaucoma patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: postoperative satisfaction rate in both group
time frame: after surgery up to 6 weeks
description: the rate of satisfaction
measure: knowledge about glaucoma
time frame: before surgery and after surgey 1 week and 6 weeks
description: the knowledge about glaucoma scores
measure: willingness to recommend surgery
time frame: after surgery 1 week and 6 weeks
description: The rate of willingness to recommend surgery
measure: personality in both groups
time frame: Baseline (before surgery)
description: use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ_RSC) access glaucoma patients personality
measure: intraocular pressure and visual acuity in both groups
time frame: before surgery and after surgery 1week and 6 weeks
description: intraocular pressure and visual acuity in both groups
arm group label: film and trained counseling
arm group type: Experimental
description: Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session and follow up counseling after operation 1 week and 6 weeks
arm group label: traditional counseling
arm group type: Other
description: Subjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse.
intervention type: Behavioral
intervention name: film and trained counseling
description: Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session.
arm group label: film and trained counseling
intervention type: Other
intervention name: traditional counseling
description: Subjects will be not participate or participate in a pre-operative/post-operative counseling session with a rural hospital's doctor/nurse as usual traditional methods.
arm group label: film and trained counseling
arm group label: traditional counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan Congdon, MD,MPH
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Congdon Nathan
investigator title: Guangdong Educational Intervention for Rural Glaucoma surgical patient
mesh term: Glaucoma