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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03240848
Other study ID # CCPMOH2017-China-5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 9, 2017
Est. completion date May 25, 2018

Study information

Verified date July 2018
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date May 25, 2018
Est. primary completion date May 25, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 14 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
China Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The accuracy of artificial intelligence diagnosis for congenital cataract The accuracy of artificial intelligence diagnosis was calculated. baseline
Secondary The evaluation of disease severity and treatment determination The accuracy of the evaluation of disease severity and treatment determination was calculated baseline
Secondary The time consuming of diagnosis The time consuming of diagnosis was calculated. baseline
Secondary The level of patients' satisfaction The information about patients' satisfaction was recorded by using a questionnaire. baseline
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