Comparison of Artificial Intelligent Clinic and Normal Clinic

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: artificial intelligent clinic; Procedure: normal clinic; Procedure: experts diagnose

• Registration Number: NCT03240848
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-07-30
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2017-08-09
• Primary Completion: 2018-05-25
• Study Completion: 2018-05-25
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
artificial intelligent clinic	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.
normal clinic	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.
normal clinic	experts diagnose	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.
artificial intelligent clinic	experts diagnose	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.

Primary Outcome Measures

Name	Time	Method
The accuracy of artificial intelligence diagnosis for congenital cataract	baseline	The accuracy of artificial intelligence diagnosis was calculated.

Secondary Outcome Measures

Name	Time	Method
The level of patients' satisfaction	baseline	The information about patients' satisfaction was recorded by using a questionnaire.
The time consuming of diagnosis	baseline	The time consuming of diagnosis was calculated.
The evaluation of disease severity and treatment determination	baseline	The accuracy of the evaluation of disease severity and treatment determination was calculated

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China