Validation of the Utility of an Intelligent Visual Acuity... | NCT03766737

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

NCT03766737

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Dec 6, 2018Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Ophthalmopathy
Artificial Intelligence

Interventions

An intelligent visual acuity diagnostic system for children

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2018Actual

Primary Completion Date

Jul 20, 2018Actual

Completion Date

Jul 20, 2018Actual

First Submitted Date

Dec 5, 2018

First Submission Date that Met QC Criteria

Dec 5, 2018

First Posted Date

Dec 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2018

Last Update Posted Date

Dec 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eligible patients for AI test.	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
An intelligent visual acuity diagnostic system for children	Device	An artificial intelligence to make evaluation and of children's vision.	Eligible patients for AI test.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Paediatric patients from eye clinic written informed consents provided

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lin Haotian, M.D, Ph.D	Zhongshan Ophthalmic Center, Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center, Sun Yat-sen University		Guangzhou	Guangdong	510000	China

Condition Browse Module

MeSH Terms

ID	Term
D005128	Eye Diseases
D014786	Vision Disorders

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided