Corrected Measurement of the Retinal Nerve Fiber Layer Thickness by Optic Disc Configuration With the Cirrus HD OCT - Full Text View

Sponsored by:	Yonsei University
Information provided by:	Yonsei University
ClinicalTrials.gov Identifier:	NCT00741130

Purpose

Because the measurement of the retinal nerve fiber layer thickness is very sensitive to the position of measurement, it may be incorrect in patients with the tilted disc. In the present study, the corrected RNFL thickness by the optic nerve head configuration using the Cirrus HD OCT will be evaluated. If the corrected RNFL thickness is more sensitive to detect the localized RNFL defect, the present software should be upgrade to reflect the optic nerve head configuration.

Condition
Glaucoma Myopia

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Cross-Sectional
Official Title:	Corrected Measurement of the Retinal Nerve Fiber Layer Thickness by Optic Disc Configuration With the Cirrus HD OCT

Further study details as provided by Yonsei University:

Primary Outcome Measures:

the Cirrus HD OCT [ Time Frame: when the OCT images are taking ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

automated 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 ]
refractive errors [ Time Frame: when the OCT images are taking ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
C normal volunteers
G glaucoma patients

Detailed Description:

Finding the localized retinal nerve fiber layer (RNFL) defect and measuring the RNFL thickness are two main issues for early glaucoma detection. A recently developed imaging device, the Cirrus HD OCT, offers more detailed informations about retina architecture including optic nerve head. To calculate the RNFL thickness, the software of the Cirrus HD OCT supposes an ideal optic nerve head. However, in the cases with not ideal optic disc configuration, the measurement of the RNFL thickness is not correct. Because the measurement of the RNFL thickness is extremely sensitive to the position of measurement, patients with the tilted disc are in danger of misdiagnosis. In the present study, we want to correct the RNFL thickness measurement according to the optic nerve head configuration using the Cirrus HD OCT. If the corrected RNFL thickness is more sensitive to detect the localized RNFL defect, the present software should be upgrade to reflect the optic nerve head configuration.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Volunteers of our opthalmologic clinic

Criteria

Inclusion Criteria:

normal controls or glaucoma patients
signal intensity of the OCT image > 8
cooperative subjects

Exclusion Criteria:

spherical equivalent refractive errors > +4 diopters or < -4 diopters
significant media opacity
previous intraocular surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741130

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:	3-2008-0076
Study First Received:	August 25, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00741130
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Yonsei University:

retinal nerve fiber layer
optic nerve head
Cirrus OCT

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Myopia
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009