Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians - Full Text View

Sponsored by:	Yonsei University
Information provided by:	Yonsei University
ClinicalTrials.gov Identifier:	NCT00744705

Purpose

The normal range of retinal nerve fiber layer thickness might be different between Asians and Caucasians. However, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. So, the investigators want to find its normal range of in Asians.

Condition
Glaucoma

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective
Official Title:	Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians

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:

Refractive errors [ 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Groups/Cohorts
1 Normal subjects who received routine health check-up in a comprehensive medical testing center

Detailed Description:

Characteristics of various ocular parameters are influenced by race. Because the retinal nerve fiber layer (RNFL) thickness is crucial in detecting early glaucomatous changes, its normal range is also important. Even though the normal range of RNFL thickness might be different according to race, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. In the present study, we want to measure the RNFL thickness using the Cirrus HD OCT in normal Asian eyes and to determine its normal range in Asians.

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

Normal subjects who recieved a regular medical check-up in a comprehensive medical testing center of our institute

Criteria

Inclusion Criteria:

Normal subjects
Good quality of the OCT images (signal intensity > 8)

Exclusion Criteria:

Any ocular history
DM

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744705

Contacts

Contact: Gong Je Seong, MD, PhD

82-2-2019-3441

gjseong@yuhs.ac

Locations

Korea, Republic of
Yongdong Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 135-720

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:	3-2008-0076-3
Study First Received:	August 29, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00744705
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Yonsei University:

Retinal nerve fiber layer
Glaucoma
Myopia

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Myopia
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009