<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/NCT03240848</url>
  </required_header>
  <id_info>
    <org_study_id>CCPMOH2017-China-5</org_study_id>
    <nct_id>NCT03240848</nct_id>
  </id_info>
  <brief_title>Comparison of Artificial Intelligent Clinic and Normal Clinic</brief_title>
  <official_title>Comparison of Artificial Intelligent Clinic and Normal Clinic for Diagnosing Congenital Cataracts</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators provide participants≤14 years old the artificial intelligent&#xD;
      clinic or normal clinic in the purpose of seeking out a better way to make a definite&#xD;
      diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled&#xD;
      study aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing&#xD;
      congenital cataract.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children ≤14 years old from ophthalmic clinic without treatment were enrolled to a&#xD;
      prospective, randomized controlled study. Patients were assigned to two groups: participants&#xD;
      in group A went to the artificial intelligent clinic and get the initial diagnosis, while in&#xD;
      Group B, the participants went to the normal clinic. Investigators provide the final definite&#xD;
      diagnosis from experts for two groups. Investigators compared the accuracy of the diagnosis,&#xD;
      time consuming and the satisfaction level between two groups, aiming at comparison of&#xD;
      artificial intelligent clinic and normal clinic for diagnosing congenital cataract.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Actual">May 25, 2018</completion_date>
  <primary_completion_date type="Actual">May 25, 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>Diagnostic</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Slit-lamp photography and patient recruitment will be performed in each participating clinic by trained clinical staffs. The clinical staffs, investigators involved in data management and analysis, and experts providing the gold standard diagnosis by consensus in each clinic will be blinded to the group assignment. The study participants, the coordinator, senior consultants, and study personnel responsible for randomisation will not be masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The accuracy of artificial intelligence diagnosis for congenital cataract</measure>
    <time_frame>baseline</time_frame>
    <description>The accuracy of artificial intelligence diagnosis was calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The evaluation of disease severity and treatment determination</measure>
    <time_frame>baseline</time_frame>
    <description>The accuracy of the evaluation of disease severity and treatment determination was calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time consuming of diagnosis</measure>
    <time_frame>baseline</time_frame>
    <description>The time consuming of diagnosis was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of patients' satisfaction</measure>
    <time_frame>baseline</time_frame>
    <description>The information about patients' satisfaction was recorded by using a questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>artificial intelligent clinic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure: the initial diagnosis from artificial intelligent clinic Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.&#xD;
Procedure: the final definite diagnosis from experts After making the initial diagnosis in artificial intelligent clinic, participants in group A went to get the final definite diagnosis from experts with more than 10 years of clinical experience.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal clinic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: the initial diagnosis from normal clinic Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.&#xD;
Procedure: the final definite diagnosis from experts After making the initial diagnosis in normal clinic, participants in group B went to get the final definite diagnosis from experts with more than 10 years of clinical experience.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>artificial intelligent clinic</intervention_name>
    <description>Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.</description>
    <arm_group_label>artificial intelligent clinic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>normal clinic</intervention_name>
    <description>Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.</description>
    <arm_group_label>normal clinic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>experts diagnose</intervention_name>
    <description>After making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience.</description>
    <arm_group_label>artificial intelligent clinic</arm_group_label>
    <arm_group_label>normal clinic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Paediatric patients from collaborating eye clinics Written informed consents provided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Definitive diagnosis of cataract or other ocular abnormalities Previous eye surgery&#xD;
             Can not cooperate with the slip lamp examination Unwilling to participate in this&#xD;
             trail&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haotian Lin, M.D,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhognshan Ophthalmic Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 26, 2018</last_update_submitted>
  <last_update_submitted_qc>July 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Haotian Lin</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>congenital cataract</keyword>
  <keyword>artificial intelligent clinic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT03240848
org study id: CCPMOH2017-China-5
nct id: NCT03240848
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators provide participants≤14 years old the artificial intelligent
      clinic or normal clinic in the purpose of seeking out a better way to make a definite
      diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled
      study aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing
      congenital cataract.
Children ≤14 years old from ophthalmic clinic without treatment were enrolled to a
      prospective, randomized controlled study. Patients were assigned to two groups: participants
      in group A went to the artificial intelligent clinic and get the initial diagnosis, while in
      Group B, the participants went to the normal clinic. Investigators provide the final definite
      diagnosis from experts for two groups. Investigators compared the accuracy of the diagnosis,
      time consuming and the satisfaction level between two groups, aiming at comparison of
      artificial intelligent clinic and normal clinic for diagnosing congenital cataract.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Investigator, Outcomes Assessor)
masking description: Slit-lamp photography and patient recruitment will be performed in each participating clinic by trained clinical staffs. The clinical staffs, investigators involved in data management and analysis, and experts providing the gold standard diagnosis by consensus in each clinic will be blinded to the group assignment. The study participants, the coordinator, senior consultants, and study personnel responsible for randomisation will not be masked.
measure: The accuracy of artificial intelligence diagnosis for congenital cataract
time frame: baseline
description: The accuracy of artificial intelligence diagnosis was calculated.
measure: The evaluation of disease severity and treatment determination
time frame: baseline
description: The accuracy of the evaluation of disease severity and treatment determination was calculated
measure: The time consuming of diagnosis
time frame: baseline
description: The time consuming of diagnosis was calculated.
measure: The level of patients' satisfaction
time frame: baseline
description: The information about patients' satisfaction was recorded by using a questionnaire.
arm group label: artificial intelligent clinic
arm group type: Experimental
description: Procedure: the initial diagnosis from artificial intelligent clinic Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
Procedure: the final definite diagnosis from experts After making the initial diagnosis in artificial intelligent clinic, participants in group A went to get the final definite diagnosis from experts with more than 10 years of clinical experience.
arm group label: normal clinic
arm group type: Active Comparator
description: Procedure: the initial diagnosis from normal clinic Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
Procedure: the final definite diagnosis from experts After making the initial diagnosis in normal clinic, participants in group B went to get the final definite diagnosis from experts with more than 10 years of clinical experience.
intervention type: Procedure
intervention name: artificial intelligent clinic
description: Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
arm group label: artificial intelligent clinic
intervention type: Procedure
intervention name: normal clinic
description: Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
arm group label: normal clinic
intervention type: Procedure
intervention name: experts diagnose
description: After making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience.
arm group label: artificial intelligent clinic
arm group label: normal clinic
criteria: 
gender: All
minimum age: 1 Month
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haotian Lin, M.D,Ph.D
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Haotian Lin
investigator title: Clinical Professor
mesh term: Cataract