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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03766737

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

24.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

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 :

Jul 20, 2018

Actual Study Completion Date :

Jul 20, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system. [Up to 5 years]

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 eye clinic written informed consents provided

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haotian Lin, Clinical Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03766737

Other Study ID Numbers:

CCPMOH2018-China-12

First Posted:

Dec 6, 2018

Last Update Posted:

Dec 6, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University

Vision Disorders

Additional relevant MeSH terms:

Eye Diseases

Study Results

No Results Posted as of Dec 6, 2018