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

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

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.

Study Overview

• Status: Completed
• Conditions: Artificial Intelligence; Ophthalmopathy
• Intervention / Treatment: Device: An intelligent visual acuity diagnostic system for children

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Paediatric patients from eye clinic written informed consents provided

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2018
• Primary Completion (ACTUAL): July 20, 2018
• Study Completion (ACTUAL): July 20, 2018

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (ACTUAL): December 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Vision Disorders
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: CCPMOH2018-China-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No