Discriminating Ability of the Cirrus High Definition (HD) Optical Coherence Tomography (OCT) for Glaucoma

Glaucoma Clinical Trial

Official title:

Discriminating Ability of the Cirrus HD OCT for Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00742378
• Other study ID #: 3-2008-0076-Reproducibility
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2008
• Last updated: September 22, 2008
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: September 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, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied.

Description:

The Cirrus HD OCT is a newly developed imaging device of the spectral domain optical coherence tomography. Even though its resolution and speed are much better than the previous OCT, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (RNFL) have not known yet. In the present study, we will review the data of RNFL thickness measurement using the Cirrus HD OCT. After assessing the inter-test variability, the discriminating ability of the Cirrus HD OCT for glaucoma diagnosis will be determined by the ROC curves.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Cooperative patients

• Repeated OCT data

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: Cross-Sectional

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	Red-free fundus photo		when the OCT images are taking	No
Secondary	Visual field		when the OCT images are taking	No
Secondary	Intraocular pressure		when the OCT images are taking	No