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Artificial Intelligence Screening on Patients With Primary Angle Closure Glaucoma (AI)

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ClinicalTrials.gov Identifier: NCT03611387
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
University of California
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Brief Summary:
The Tomey CASIA (Tomey Corporation, Nagoya, Japan) is a novel rapid imaging device that captures high-quality imaging of the entire anterior chamber of the eye over detailed imaging of a single section. In this prospective study, we want to investigate and compare the anatomical structure of the drainage angle of the eye in patients with different types glaucoma using Tomey machine. This study gives us a better understanding of the predictability, validity and accuracy of Tomey machine in the diagnosis of different types of glaucoma. Moreover, the data collected here will be used to create an artificial intelligence (AI) platform to screen certain type of glaucoma.

Condition or disease Intervention/treatment
Ophthalmopathy Device: CASIA 2 OCT

Detailed Description:
Patients ≥18 years old from ophthalmic clinics with or without glaucoma were enrolled to this respective observational clinical study. However, patients with any history of eye surgery (except cataract surgery) including laser procedure were excluded. The investigators will review patients' medical chart and update any medical history in your medical record. If new scans are needed, investigators will do them at the time of patients' current visit and it will require about 30 mins. CASIA SS-OCT (CASIA 2) is a non-contact scan of the front of the eye with higher resolution and provides deeper, wider and three- dimensional views. It is the newest scan machine. It is not FDA-approved but is approved in many other countries including Japan for patient use. We may perform the scan in the light and dark condition. We may also perform the routine scan to capture images of the anterior part of the eye for comparison purpose. The results of the scanned data will be among patients' medical records. Age, sex and ethnicity within your medical records will also be used for the analysis.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Artificial Intelligence Screening on Patients With Primary Angle Closure Glaucoma
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
Normal
Patients without any type of glaucoma
Device: CASIA 2 OCT
Using CASIA 2 OCT to assess the anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods

Primary angle closure glaucoma
Patients with primary angle closure glaucoma
Device: CASIA 2 OCT
Using CASIA 2 OCT to assess the anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods

Primary open-angle glaucoma
Patients with primary open-angle glaucoma
Device: CASIA 2 OCT
Using CASIA 2 OCT to assess the anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods




Primary Outcome Measures :
  1. The accuracy of the CASIA 2 OCT [ Time Frame: baseline ]
    To compare the clinical applicability, accuracy, and validity of the CASIA 2 OCT (Tomey, Nagoya, Japan) in the assessment of anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods.

  2. The sensitivity and specificity of the AI [ Time Frame: baseline ]
    To create an AI program to reliably screen patients with certain type of glaucoma (such as primary angle closure glaucoma, PACG) using images from CASIA 2 OCT. To test the sensitivity and specificity of the AI program to screen patients with glaucoma using images from CASIA 2 OCT. Another database comprised of CASIA 2 OCT images will be created and used to test the AI program. The diagnosis based on the AI program will be compared with diagnosis from glaucoma specialist.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Outpatients ≥18 years old with or without glaucoma
Criteria

Inclusion Criteria:

  • Patient with or without glaucoma

Exclusion Criteria:

  • Patients with any history of eye surgery (except cataract surgery) including laser procedure.
  • Age < =18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611387


Contacts
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Contact: Jing Li, M.D +86-20-87330341 Reviewborad_SYsU@163.com
Contact: Haotian Lin, M.D,Ph.D

Locations
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China, Guangdong
Zhognshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Haotian Lin, M.D., Ph.D.    8613802793086    haot.lin@hotmail.com   
Contact: Jing Li, M.D.    +86-20-87330341    Reviewborad_SYsU@163.com   
Sponsors and Collaborators
Sun Yat-sen University
University of California

Additional Information:

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Responsible Party: Haotian Lin, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03611387     History of Changes
Other Study ID Numbers: CCPMOH2018-China-4
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haotian Lin, Sun Yat-sen University:
Primary Angle-Closure Glaucoma
Artificial Intelligence
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Angle-Closure
Eye Diseases
Ocular Hypertension