Retinal Nerve Fiber Layer Thickness Analysis With Cirrus HD OCT Versus Stratus Optical Coherence Tomography (OCT)

Glaucoma Clinical Trial

Official title:

Retinal Nerve Fiber Layer Thickness Analysis With Cirrus HD OCT Versus Stratus OCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00766389
• Other study ID #: 3-2008-0113
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2008
• Last updated: October 3, 2008
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: October 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 Cirrus HD OCT, a new spectral domain optical coherence tomography (OCT), has better resolution than the previous time domain Stratus OCT. Discriminating ability of these two OCTs for diagnosis of glaucoma and judgement of disease progression will be studied.

Description:

The Cirrus HD OCT is a new spectral domain OCT. Even though its resolution and speed are much better than the previous time domain Stratus OCT, its diagnostic power for glaucoma detection and judgement of disease progression should be directly compared with Stratus OCT. In the present study, we will review the data of peripapillary retinal nerve fiber layer thickness measurement using the Cirrus HD OCT and Stratus OCT. Their discriminating ability for diagnosis of glaucoma and judgement of disease progression will be compared using the ROC curves and Cohen's kappa.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Retinal nerve fiber layer analysis with Cirrus OCT and Stratus OCT within 1 month

Exclusion Criteria:

• Intraocular surgeries history

• DM

• High refractive error ( < -4.00 diopters, or > + 4.00 diopters)

• Media opacity

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Glaucoma

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	Retinal nerve fiber layer thickness		When the OCT images are taking	No
Secondary	Visual field		When the OCT images are taking	No
Secondary	Red-free fundus photo		When the OCT images are taking	No
Secondary	Intraocular pressure		When the OCT images are taking	No
Secondary	Central corneal thickness		When the OCT images are taking	No