NCT04014725

Brief Summary

The screening of myopia via artificial intelligence represents an challenge in computational medicine. Here, the investigators use "deep learning" to create an automatic diagnostic system for myopia screening using ocular appearance images. The investigator also use this system and conduct clinical trial to validate its performance.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

July 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

22 days

First QC Date

July 1, 2019

Last Update Submit

July 8, 2019

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • The AUC of the Myopia Intelligent Diagnostic System

    up to 3 month

Secondary Outcomes (2)

  • The sensitivity of the Myopia Intelligent Diagnostic System

    up to 3 month

  • The specificity of the Myopia Intelligent Diagnostic System

    up to 3 month

Study Arms (1)

Eligible patients for AI test

EXPERIMENTAL
Device: Myopia Intelligent Diagnostic System

Interventions

Myopia Intelligent Diagnostic SystemDEVICE

An artificial intelligence to make diagnosis of myopia using ocular appearance images

Eligible patients for AI test

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Student aged 6-18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Yahan Yang

CONTACT

+8615521013933yah.yang39@hotmail.com

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

July 1, 2019

First Posted

July 10, 2019

Study Start

July 10, 2019

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07