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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00742378
First received: August 26, 2008
Last updated: September 22, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Discriminating Ability of the Cirrus HD OCT for Glaucoma

Resource links provided by NLM:

U.S. FDA Resources

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:
  • Red-free fundus photo [ Time Frame: when the OCT images are taking ] [ Designated as safety issue: No ]
  • Visual field [ 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: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
C
Normal controls
G
Glaucoma

Detailed 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.

  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

Glaucoma patients and normal controls

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742378

Contacts
Contact: Gong Je Seong, MD, PhD 82-2-2019-3441 gjseong@yuhs.ac

Locations
Korea, Republic of
Gong Je Seong 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
Principal Investigator: Gong Je Seong, MD, PhD Yonsei University College of Medicine
  More Information

No publications provided

Responsible Party: Gong Je Seong, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT00742378     History of Changes
Other Study ID Numbers: 3-2008-0076-Reproducibility
Study First Received: August 26, 2008
Last Updated: September 22, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Glaucoma
Retinal nerve fiber layer
Cirrus OCT

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013