NCT03766737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

December 5, 2018

Last Update Submit

December 5, 2018

Conditions

OphthalmopathyArtificial Intelligence

Keywords

Vision Disorders

Outcome Measures

Primary Outcomes (1)

  • The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system.

    Up to 5 years

Study Arms (1)

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

An intelligent visual acuity diagnostic system for childrenDEVICE

An artificial intelligence to make evaluation and of children's vision.

Eligible patients for AI test.

Eligibility Criteria

Age1 Month - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Paediatric patients from eye clinic written informed consents provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Eye DiseasesVision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lin Haotian, M.D, Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

May 20, 2018

Primary Completion

July 20, 2018

Study Completion

July 20, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Locations

CN(1)