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

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ClinicalTrials.gov Identifier: NCT00744705
Recruitment Status : Unknown
Verified August 2008 by Yonsei University.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2008
Last Update Posted : September 1, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Glaucoma

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.

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians
Study Start Date : September 2008
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Retinal nerve fiber layer thickness [ Time Frame: when the OCT images are taking ]

Secondary Outcome Measures :
  1. Refractive errors [ Time Frame: when the OCT images are taking ]
  2. Intraocular pressure [ Time Frame: when the OCT images are taking ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Not yet 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
More Information

Responsible Party: Gong Je Seong, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT00744705     History of Changes
Other Study ID Numbers: 3-2008-0076-3
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: September 1, 2008
Last Verified: August 2008

Keywords provided by Yonsei University:
Retinal nerve fiber layer
Glaucoma
Myopia

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases