Retinal Nerve Fiber Layer Thickness Analysis With Cirrus HD OCT Versus Stratus Optical Coherence Tomography (OCT) - Full Text View

Sponsored by:	Yonsei University
Information provided by:	Yonsei University
ClinicalTrials.gov Identifier:	NCT00766389

Purpose

The Cirrus HD OCT, a new spectral domain optical coherence tomography (OCT), has better resolution than the previous time domain Stratus OCT. Discriminating ability of these two OCTs for diagnosis of glaucoma and judgement of disease progression will be studied.

Condition
Glaucoma

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Retrospective
Official Title:	Retinal Nerve Fiber Layer Thickness Analysis With Cirrus HD OCT Versus Stratus OCT

Further study details as provided by Yonsei University:

Primary Outcome Measures:

Retinal nerve fiber layer thickness [ Time Frame: When the OCT images are taking ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual field [ Time Frame: When the OCT images are taking ] [ Designated as safety issue: No ]
Red-free fundus photo [ Time Frame: When the OCT images are taking ] [ Designated as safety issue: No ]
Intraocular pressure [ Time Frame: When the OCT images are taking ] [ Designated as safety issue: No ]
Central corneal thickness [ Time Frame: When the OCT images are taking ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Defined glaucoma patients
2 Glaucoma suspects and normal controls

Detailed Description:

The Cirrus HD OCT is a new spectral domain OCT. Even though its resolution and speed are much better than the previous time domain Stratus OCT, its diagnostic power for glaucoma detection and judgement of disease progression should be directly compared with Stratus OCT. In the present study, we will review the data of peripapillary retinal nerve fiber layer thickness measurement using the Cirrus HD OCT and Stratus OCT. Their discriminating ability for diagnosis of glaucoma and judgement of disease progression will be compared using the ROC curves and Cohen's kappa.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Defined glaucoma patients and glaucoma suspects

Criteria

Inclusion Criteria:

Retinal nerve fiber layer analysis with Cirrus OCT and Stratus OCT within 1 month

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766389

Contacts

Contact: Gong Je Seong, MD, PhD

82-2-2019-3441

gjseong@yuhs.ac

Locations

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

Sponsors and Collaborators

Yonsei University

Investigators

Study Chair:

Gong Je Seong, MD, PhD

Yonsei University College of Medicine

More Information

Responsible Party:	Yonsei University College of Medicine ( Gong Je Seong )
Study ID Numbers:	3-2008-0113
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766389
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Yonsei University:

Glaucoma
Retinal nerve fiber layer
Cirrus OCT
Stratus OCT

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009