NCT03611387

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.

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
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

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

Study Start

First participant enrolled

April 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

July 26, 2018

Last Update Submit

July 26, 2018

Conditions

Keywords

Primary Angle-Closure GlaucomaArtificial Intelligence

Outcome Measures

Primary Outcomes (2)

  • The accuracy of the CASIA 2 OCT

    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

    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

Study Arms (3)

Normal

Patients without any type of glaucoma

Device: CASIA 2 OCT

Primary angle closure glaucoma

Patients with primary angle closure glaucoma

Device: CASIA 2 OCT

Primary open-angle glaucoma

Patients with primary open-angle glaucoma

Device: CASIA 2 OCT

Interventions

Using CASIA 2 OCT to assess the anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods

NormalPrimary angle closure glaucomaPrimary open-angle glaucoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatients ≥18 years old with or without glaucoma

You may qualify if:

  • Patient with or without glaucoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Eye DiseasesGlaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular Hypertension

Central Study Contacts

Haotian Lin, M.D,Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 2, 2018

Study Start

April 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations