NCT03268031

Brief Summary

Glaucoma is currently the second leading cause of irreversible blindness in the world. Our study intends to combine clinical data of glaucoma patients in Zhongshan Ophthalmic Center with Artificial Intelligence techniques to create programs that can screen and diagnose glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

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

August 15, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

August 29, 2017

Last Update Submit

October 19, 2020

Conditions

Keywords

artificial intelligenceglaucoma

Outcome Measures

Primary Outcomes (1)

  • Accuracy of diagnosis by artificial intelligence algorithm

    Accuracy of diagnosis by artificial intelligence algorithm and compare this result with glaucoma specialists

    from August 2017 to February 2021

Secondary Outcomes (2)

  • Sensitivity of diagnosis by artificial intelligence algorithm

    from August 2017 to February 2021

  • Specificity of diagnosis by artificial intelligence algorithm

    from August 2017 to February 2021

Study Arms (2)

Glaucoma patients

Glaucoma patients will take visual field test and OCT imaging of optic nerve area. All of these data will be collected as source of machine learning.

Diagnostic Test: Visual field and OCT tests

Non-glaucoma participants

Non-glaucoma participants will take visual field test and OCT imaging of optic nerve area. All of these data will be collected as source of machine learning.

Diagnostic Test: Visual field and OCT tests

Interventions

Visual field test and OCT are commonly used essential tests to make accurate diagnosis of glaucoma. Algorithms to classify Visual field and OCT tests would both be developed and verified.

Glaucoma patientsNon-glaucoma participants

Eligibility Criteria

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

Anyone who can complete visual field test and have BCVA\>0.1 can be enrolled. We will collect visual field test result and OCT images of both glaucoma and non-glaucoma patients.

You may qualify if:

  • BCVA\>0.1
  • able to complete reliable visual field test
  • no history of intraocular surgery or fundus laser

You may not qualify if:

  • \. unable to complete visual field test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (3)

  • Diprose W, Buist N. Artificial intelligence in medicine: humans need not apply? N Z Med J. 2016 May 6;129(1434):73-6.

  • Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.

  • Asaoka R, Murata H, Iwase A, Araie M. Detecting Preperimetric Glaucoma with Standard Automated Perimetry Using a Deep Learning Classifier. Ophthalmology. 2016 Sep;123(9):1974-80. doi: 10.1016/j.ophtha.2016.05.029. Epub 2016 Jul 7.

MeSH Terms

Conditions

Glaucoma

Interventions

Visual Fields

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

  • Xiulan Zhang, Doctor

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research Center

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 31, 2017

Study Start

August 15, 2017

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations