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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03268031
Other study ID # ProjectAGE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 15, 2017
Est. completion date February 1, 2020

Study information

Verified date October 2020
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Glaucoma is currently the second leading cause of irreversible blindness in the world, which brings heavy burden to human society. Compared to other ocular diseases, diagnostic process of glaucoma is complicated depends on multiple test results, including visual field test, OCT, etc. How to diagnose glaucoma correctly and fast has always been a hot topic in glaucoma researches. Artificial intelligence is used to study and develop theories and methods that can help simulate and extend human intelligence, which has been utilized in a lot of research fields such as automatic drive and medicine. The 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.


Recruitment information / eligibility

Status Completed
Enrollment 10800
Est. completion date February 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. BCVA>0.1 2. able to complete reliable visual field test 3. no history of intraocular surgery or fundus laser Exclusion Criteria: 1. unable to complete visual field test

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Visual field and OCT tests
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.

Locations

Country Name City State
China Zhongshan Ophthalmic Center Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Sensitivity of diagnosis by artificial intelligence algorithm Sensitivity of diagnosis by artificial intelligence algorithm from August 2017 to February 2021
Secondary Specificity of diagnosis by artificial intelligence algorithm Specificity of diagnosis by artificial intelligence algorithm from August 2017 to February 2021
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