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Comparison of Artificial Intelligent Clinic and Normal Clinic

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ClinicalTrials.gov Identifier: NCT03240848
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Procedure: artificial intelligent clinic Procedure: normal clinic Procedure: experts diagnose Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Diagnostic
Official Title: Comparison of Artificial Intelligent Clinic and Normal Clinic for Diagnosing Congenital Cataracts
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: artificial intelligent clinic

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.

Procedure: 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: experts diagnose
After making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience.

Active Comparator: normal clinic

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.

Procedure: 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: experts diagnose
After making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience.




Primary Outcome Measures :
  1. The accuracy of artificial intelligence diagnosis for congenital cataract [ Time Frame: baseline ]
    The accuracy of artificial intelligence diagnosis was calculated.


Secondary Outcome Measures :
  1. The evaluation of disease severity and treatment determination [ Time Frame: baseline ]
    The accuracy of the evaluation of disease severity and treatment determination was calculated

  2. The time consuming of diagnosis [ Time Frame: baseline ]
    The time consuming of diagnosis was calculated.

  3. The level of patients' satisfaction [ Time Frame: baseline ]
    The information about patients' satisfaction was recorded by using a questionnaire.



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Ages Eligible for Study:   1 Month to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Paediatric patients from collaborating eye clinics Written informed consents provided

Exclusion Criteria:

  • Definitive diagnosis of cataract or other ocular abnormalities Previous eye surgery Can not cooperate with the slip lamp examination Unwilling to participate in this trail

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240848


Locations
China, Guangdong
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Haotian Lin, M.D,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03240848     History of Changes
Other Study ID Numbers: CCPMOH2017-China-5
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haotian Lin, Sun Yat-sen University:
congenital cataract
artificial intelligent clinic

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases