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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00741130
• Other study ID #: 3-2008-0076
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2008
• Last updated: August 25, 2008
• Start date: July 2008
• Est. completion date: January 2009

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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Glaucoma
• Myopia

Locations

Country	Name	City	State
Korea, Republic of	Gong Je Seong	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	the Cirrus HD OCT		when the OCT images are taking	No
Secondary	automated visual field		when the OCT images are taking	No
Secondary	red-free fundus photo		when the OCT images are taking	No
Secondary	refractive errors		when the OCT images are taking	No