Discriminating Ability of the Cirrus High Definition (HD) Optical Coherence Tomography (OCT) for Glaucoma

September 22, 2008 updated by: Yonsei University

Discriminating Ability of the Cirrus HD OCT for Glaucoma

The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied.

Study Overview

Status

Unknown

Conditions

Glaucoma

Detailed Description

The Cirrus HD OCT is a newly developed imaging device of the spectral domain optical coherence tomography. Even though its resolution and speed are much better than the previous OCT, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (RNFL) have not known yet. In the present study, we will review the data of RNFL thickness measurement using the Cirrus HD OCT. After assessing the inter-test variability, the discriminating ability of the Cirrus HD OCT for glaucoma diagnosis will be determined by the ROC curves.

Study Type

Observational

Enrollment (Anticipated)

200

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

Korea, Republic of
- - Seoul, Korea, Republic of, 135-720
    - Recruiting
    - Gong Je Seong
    - Contact:
      
      Gong Je Seong, MD, PhD
      
      Phone Number: 82-2-2019-3441
      
      Email: gjseong@yuhs.ac
    - Principal Investigator:
      
      Gong Je Seong, MD, PhD

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Glaucoma patients and normal controls

Description

Inclusion Criteria:

Cooperative patients
Repeated OCT data

Exclusion Criteria:

Intraocular surgeries history
DM
High refractive error ( < -4.00 diopters, or > + 4.00 diopters)
Media opacity

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
C Normal controls
G Glaucoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retinal nerve fiber layer thickness Time Frame: when the OCT images are taking	when the OCT images are taking

Secondary Outcome Measures

Outcome Measure	Time Frame
Intraocular pressure Time Frame: when the OCT images are taking	when the OCT images are taking
Red-free fundus photo Time Frame: when the OCT images are taking	when the OCT images are taking
Visual field Time Frame: when the OCT images are taking	when the OCT images are taking

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

Principal Investigator: Gong Je Seong, MD, PhD, Yonsei University

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

September 1, 2008

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria