Comparison of Artificial Intelligent Clinic and Normal Clinic

NCT03240848 | Completed DMC

• 1 other identifier: CCPMOH2017-China-5
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

congenital cataract; artificial intelligent clinic

Outcome Measures

Primary Outcomes (1)

• The accuracy of artificial intelligence diagnosis for congenital cataract

  The accuracy of artificial intelligence diagnosis was calculated.

  baseline

Secondary Outcomes (3)

• The evaluation of disease severity and treatment determination

  baseline

• The time consuming of diagnosis

  baseline

• The level of patients' satisfaction

  baseline

Study Arms (2)

artificial intelligent clinic

EXPERIMENTAL

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; Procedure: experts diagnose

normal clinic

ACTIVE COMPARATOR

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; Procedure: experts diagnose

Interventions

artificial intelligent clinic PROCEDURE

Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.

artificial intelligent clinic

normal clinic PROCEDURE

Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.

normal clinic

experts diagnose PROCEDURE

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

artificial intelligent clinic; normal clinic

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Paediatric patients from collaborating eye clinics Written informed consents provided

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 31143882 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Haotian Lin, M.D,Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 30, 2017
• First Posted: August 7, 2017
• Study Start: August 9, 2017
• Primary Completion: May 25, 2018
• Study Completion: May 25, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

CN (1)