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

July 26, 2018 updated by: Haotian Lin, Sun Yat-sen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhognshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatients ≥18 years old with or without glaucoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

University of California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2018-China-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe