Artificial Intelligence-assisted Glaucoma Screening (AIAGS) | NCT03682783

Studies
Artificial Intelligence-assisted Glaucoma Screening (AIAGS)

NCT03682783

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Sep 25, 2018Actual

Enrollment

8,000Estimated

Phase

Not provided

Conditions

Glaucoma Eye

Interventions

Fundus Image

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Estimated

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Oct 30, 2021Estimated

First Submitted Date

Sep 21, 2018

First Submission Date that Met QC Criteria

Sep 21, 2018

First Posted Date

Sep 25, 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

Sep 21, 2018

Last Update Posted Date

Sep 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haiyan Wang, Attending of Ophthalmology, M.D. Ph.D., Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This study will develop an artificial intelligence (AI) program for the screening of glaucoma.

Detailed Description

We have realized that the glaucomatous optic neuropathy is irreversible. But if early detection and early intervention can be performed to control the development of the disease, it can greatly reduce the blindness rate of glaucoma, improve the life quality and physiological and mental health of patients, and alleviate the social burden. Therefore, screening and early diagnosis of glaucoma is the focus of glaucoma prevention.

China has a population of 1.3 billion, which greatly increase the difficulty of disease screening. In recent years, the intersection of artificial intelligence (AI) technology and modern medicine has made efficient and rapid disease screening possible.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fundus Image		Glaucomatous and Non-glaucomatous fundus images that have been taken from the last 5 years in Shanghai General hospital.	Diagnostic Test: Fundus Image

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fundus Image	Diagnostic Test	Fundus image of optic nerve	Fundus Image

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The specificity of the algorithm for diagnosing glaucoma	The specificity of the algorithm for diagnosing glaucoma will be calculated ...	from January 2020 to March 2021
The sensitivity of the algorithm for diagnosing glaucoma	The sensitivity of the algorithm for diagnosing glaucoma will be calculated .	from January 2020 to March 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

able to complete fundus images

Exclusion Criteria:

unable to complete fundus images

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Both glaucoma and non-glaucoma patients who can complete fundus image test will be enrolled.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haiyan Wang, Ph.D.	Contact	+86 15000096256		catherinecnc81@126.com
Kun Liu, Ph.D.	Contact	+86 36126112		drliukun@sjtu.edu.cn

Overall Officials

Name	Affiliation	Role
Haiyan Wang, Ph.D.	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai General Hospital		Shanghai	Shanghai Municipality	200080	China

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided