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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Yonsei University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00744705
First received: August 29, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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

No publications provided

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
Study First Received: August 29, 2008
Last Updated: August 29, 2008
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014