Comparison of Artificial Intelligent Clinic and Normal Clinic

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03240848
Collaborator
(none)
350
Enrollment
1
Location
2
Arms
9.5
Actual Duration (Months)
36.9
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: artificial intelligent clinic
  • Procedure: normal clinic
  • Procedure: experts diagnose
N/A

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 Design

Study Type:
Interventional
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 :
Aug 9, 2017
Actual Primary Completion Date :
May 25, 2018
Actual Study Completion Date :
May 25, 2018

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. The accuracy of artificial intelligence diagnosis for congenital cataract [baseline]

    The accuracy of artificial intelligence diagnosis was calculated.

Secondary Outcome Measures

  1. The evaluation of disease severity and treatment determination [baseline]

    The accuracy of the evaluation of disease severity and treatment determination was calculated

  2. The time consuming of diagnosis [baseline]

    The time consuming of diagnosis was calculated.

  3. The level of patients' satisfaction [baseline]

    The information about patients' satisfaction was recorded by using a questionnaire.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Zhognshan Ophthalmic Center, Sun Yat-sen UniversityGuangzhouGuangdongChina510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Haotian Lin, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03240848
Other Study ID Numbers:
  • CCPMOH2017-China-5
First Posted:
Aug 7, 2017
Last Update Posted:
Jul 30, 2018
Last Verified:
Jul 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 30, 2018