<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/NCT02185807</url>
  </required_header>
  <id_info>
    <org_study_id>GZFPH-IRB-2013-087</org_study_id>
    <nct_id>NCT02185807</nct_id>
  </id_info>
  <brief_title>Video-assisted Informed Consent for Cataract Surgery</brief_title>
  <official_title>Does Video-assisted Informed Consent for Cataract Surgery Improve Patients' Satisfaction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou First People's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will investigate whether video-assisted informed consent is superior to&#xD;
      routine discussion for cataract patients about risks, benefits and alternatives to receiving&#xD;
      phacoemulsification cataract extract and intraocular lens implantation, and will determine&#xD;
      whether video-assisted informed consent can reduce the work load of physicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with age-related cataract who scheduled for elective phacoemulsification cataract&#xD;
      extract and intraocular lens implantation surgery and their physicians who on charge of these&#xD;
      patients will be enrolled in the study. Patients will be randomized to the video assistance&#xD;
      group watched a video in Cantonese or Mandarin explaining the surgery procedure and its&#xD;
      risks, benefits and alternatives before discussion with their physicians. The control group&#xD;
      will receive traditional verbal information and discussion from their physicians. A&#xD;
      questionnaire for patients will be administered to assess the comprehension and satisfaction&#xD;
      with the informed consent process before surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>overall patients satisfaction with informed concent</measure>
    <time_frame>The same day after the surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients refusing to sign consent</measure>
    <time_frame>The same day of surgery</time_frame>
    <description>The proportion of patients who refuse to sign consent for the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A 10-question cataract surgery knowledge measure</measure>
    <time_frame>The same day after the surgery</time_frame>
    <description>A written examination (0% to 100%) on patient understanding of the risks, benefits, and alternatives of cataract surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Cataract</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>video-assisted group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The video assistance patients watch a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians, and receive face- to face discussion with their physicians as well.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control patients receive verbal information and discussion from their physicians.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>video-assisted group</intervention_name>
    <description>The video assistance patients watch a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians.</description>
    <arm_group_label>video-assisted group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>The control patients receive verbal information and discussion from their physicians.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with age-related cataract scheduled for elective phacoemulsification and&#xD;
        intraocular lens implantation for the first time in Department of Ophthalmology, Affiliated&#xD;
        Hospital of Guangdong Medical College will be recruited in this study. Recruited patients&#xD;
        shall own normal intelligence and understanding capability and their best corrected visual&#xD;
        acuity more than 0.1 in either eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who have undergone previously cataract surgery or whose best corrected visual&#xD;
        acuity is lower than 0.1 in either eye or patients who complicated with complex other eye&#xD;
        diseases such as uveitis and retinal detachment or patients whose language is not cantonese&#xD;
        or mandarin will be excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuehong Zhang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou First People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Min Lu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sanshui District People's Hospital of Foshan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sanshui District People's Hospital of Foshan;Guangzhou First Peoples' Hospital, Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Foshan</city>
        <state>Guangdong</state>
        <zip>528100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou First Municipal People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>August 14, 2016</last_update_submitted>
  <last_update_submitted_qc>August 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou First People's Hospital</investigator_affiliation>
    <investigator_full_name>Yuehong Zhang</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>cataract</keyword>
  <keyword>surgery</keyword>
  <keyword>consent process</keyword>
  <keyword>video-assisted</keyword>
  <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/NCT02185807
org study id: GZFPH-IRB-2013-087
nct id: NCT02185807
lead sponsor: 
has dmc: No
The investigators will investigate whether video-assisted informed consent is superior to
      routine discussion for cataract patients about risks, benefits and alternatives to receiving
      phacoemulsification cataract extract and intraocular lens implantation, and will determine
      whether video-assisted informed consent can reduce the work load of physicians.
Patients with age-related cataract who scheduled for elective phacoemulsification cataract
      extract and intraocular lens implantation surgery and their physicians who on charge of these
      patients will be enrolled in the study. Patients will be randomized to the video assistance
      group watched a video in Cantonese or Mandarin explaining the surgery procedure and its
      risks, benefits and alternatives before discussion with their physicians. The control group
      will receive traditional verbal information and discussion from their physicians. A
      questionnaire for patients will be administered to assess the comprehension and satisfaction
      with the informed consent process before surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: overall patients satisfaction with informed concent
time frame: The same day after the surgery
measure: The proportion of patients refusing to sign consent
time frame: The same day of surgery
description: The proportion of patients who refuse to sign consent for the surgery
measure: A 10-question cataract surgery knowledge measure
time frame: The same day after the surgery
description: A written examination (0% to 100%) on patient understanding of the risks, benefits, and alternatives of cataract surgery
arm group label: video-assisted group
arm group type: Active Comparator
description: The video assistance patients watch a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians, and receive face- to face discussion with their physicians as well.
arm group label: control group
arm group type: Placebo Comparator
description: The control patients receive verbal information and discussion from their physicians.
intervention type: Procedure
intervention name: video-assisted group
description: The video assistance patients watch a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians.
arm group label: video-assisted group
intervention type: Procedure
intervention name: control group
description: The control patients receive verbal information and discussion from their physicians.
arm group label: control group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yuehong Zhang, MD, PhD
role: Principal Investigator
affiliation: Guangzhou First People's Hospital
last name: Min Lu, MD
role: Principal Investigator
affiliation: Sanshui District People's Hospital of Foshan
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou First People's Hospital
investigator full name: Yuehong Zhang
investigator title: Dr.
mesh term: Cataract
sharing ipd: Undecided