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Comparison of Artificial Intelligent Clinic and Normal Clinic

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
artificial intelligent clinic
normal clinic
experts diagnose
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract focused on measuring congenital cataract, artificial intelligent clinic

Eligibility Criteria

1 Month - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zhognshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

artificial intelligent clinic

normal clinic

Arm 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.

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.

Outcomes

Primary Outcome Measures

The accuracy of artificial intelligence diagnosis for congenital cataract
The accuracy of artificial intelligence diagnosis was calculated.

Secondary Outcome Measures

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

Full Information

First Posted
July 30, 2017
Last Updated
July 26, 2018
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03240848
Brief Title
Comparison of Artificial Intelligent Clinic and Normal Clinic
Official Title
Comparison of Artificial Intelligent Clinic and Normal Clinic for Diagnosing Congenital Cataracts
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
May 25, 2018 (Actual)
Study Completion Date
May 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
congenital cataract, artificial intelligent clinic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artificial intelligent clinic
Arm Type
Experimental
Arm 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 Title
normal clinic
Arm Type
Active Comparator
Arm 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(s)
artificial intelligent clinic
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
normal clinic
Intervention Description
Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
Intervention Type
Procedure
Intervention Name(s)
experts diagnose
Intervention Description
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 Measure Information:
Title
The accuracy of artificial intelligence diagnosis for congenital cataract
Description
The accuracy of artificial intelligence diagnosis was calculated.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
The evaluation of disease severity and treatment determination
Description
The accuracy of the evaluation of disease severity and treatment determination was calculated
Time Frame
baseline
Title
The time consuming of diagnosis
Description
The time consuming of diagnosis was calculated.
Time Frame
baseline
Title
The level of patients' satisfaction
Description
The information about patients' satisfaction was recorded by using a questionnaire.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D,Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31143882
Citation
Lin H, Li R, Liu Z, Chen J, Yang Y, Chen H, Lin Z, Lai W, Long E, Wu X, Lin D, Zhu Y, Chen C, Wu D, Yu T, Cao Q, Li X, Li J, Li W, Wang J, Yang M, Hu H, Zhang L, Yu Y, Chen X, Hu J, Zhu K, Jiang S, Huang Y, Tan G, Huang J, Lin X, Zhang X, Luo L, Liu Y, Liu X, Cheng B, Zheng D, Wu M, Chen W, Liu Y. Diagnostic Efficacy and Therapeutic Decision-making Capacity of an Artificial Intelligence Platform for Childhood Cataracts in Eye Clinics: A Multicentre Randomized Controlled Trial. EClinicalMedicine. 2019 Mar 17;9:52-59. doi: 10.1016/j.eclinm.2019.03.001. eCollection 2019 Mar.
Results Reference
derived

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Comparison of Artificial Intelligent Clinic and Normal Clinic

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