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Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children

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ClinicalTrials.gov Identifier: NCT03766737
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Brief Summary:
Visual development during early childhood is a vital process. Examining the visual acuity of children is essential for the early detection of visual abnormality, but performing such an assessment in children is challenging. Here, the investigators developed a human-in-the-loop artificial intelligence (AI) paradigm that combines traditional vision examination and AI with integrated software and hardware, thus making the vision examination easy to perform. The investigator also establish a entity intelligent visual acuity diagnostic system based on the paradigm, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.

Condition or disease Intervention/treatment Phase
Ophthalmopathy Artificial Intelligence Device: An intelligent visual acuity diagnostic system for children Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children: Using a Human-in-the-loop Artificial Intelligence Paradigm
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018

Arm Intervention/treatment
Eligible patients for AI test.
Device: An intelligent visual acuity diagnostic system for children. An artificial intelligence to evaluate children's vision.
Device: An intelligent visual acuity diagnostic system for children
An artificial intelligence to make evaluation and of children's vision.




Primary Outcome Measures :
  1. The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system. [ Time Frame: Up to 5 years ]


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

Inclusion Criteria:

  • Paediatric patients from eye clinic written informed consents provided

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766737


Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Lin Haotian, M.D, Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03766737     History of Changes
Other Study ID Numbers: CCPMOH2018-China-12
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haotian Lin, Sun Yat-sen University:
Vision Disorders

Additional relevant MeSH terms:
Eye Diseases