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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00744705
• Other study ID #: 3-2008-0076-3
• Status: Not yet recruiting
• Phase: N/A
• First received: August 29, 2008
• Last updated: August 29, 2008
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2008
• Source: Yonsei University
• Contact: Gong Je Seong, MD, PhD
• Phone: 82-2-2019-3441
• Email: gjseong[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Normal subjects

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

Exclusion Criteria:

• Any ocular history

• DM

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
Korea, Republic of	Yongdong Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal nerve fiber layer thickness		when the OCT images are taking	No
Secondary	Refractive errors		when the OCT images are taking	No
Secondary	Intraocular pressure		when the OCT images are taking	No