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NCT03766737 Clinical Trial

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

Artificial Intelligence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03766737
Other study ID # CCPMOH2018-China-12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2018
Est. completion date July 20, 2018

Study information
Verified date December 2018
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 20, 2018
Est. primary completion date July 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 14 Years
Eligibility Inclusion Criteria:

- Paediatric patients from eye clinic written informed consents provided

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system. Up to 5 years
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