NCT03682783

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

September 21, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 21, 2018

Last Update Submit

September 21, 2018

Conditions

Glaucoma Eye

Keywords

Artificial Intelligence; Glaucoma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

Fundus ImageDIAGNOSTIC_TEST

Fundus image of optic nerve

Fundus Image

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • able to complete fundus images

You may not qualify if:

  • unable to complete fundus images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Haiyan Wang, Ph.D.

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Wang, Ph.D.

CONTACT

+86 15000096256catherinecnc81@126.com

Kun Liu, Ph.D.

CONTACT

+86 36126112drliukun@sjtu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending of Ophthalmology, M.D. Ph.D.

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 25, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2020

Study Completion

October 30, 2021

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

CN(1)