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


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.

Full Title of Study: “Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children: Using a Human-in-the-loop Artificial Intelligence Paradigm”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 20, 2018


  • Device: An intelligent visual acuity diagnostic system for children
    • An artificial intelligence to make evaluation and of children’s vision.

Arms, Groups and Cohorts

  • Other: Eligible patients for AI test.
    • Device: An intelligent visual acuity diagnostic system for children. An artificial intelligence to evaluate children’s vision.

Clinical Trial Outcome Measures

Primary Measures

  • The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system.
    • Time Frame: Up to 5 years

Participating in This Clinical Trial

Inclusion Criteria

  • Paediatric patients from eye clinic written informed consents provided

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Haotian Lin, Clinical Professor – Sun Yat-sen University
  • Overall Official(s)
    • Lin Haotian, M.D, Ph.D, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University

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