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

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ClinicalTrials.gov Identifier: NCT00741130
Recruitment Status : Unknown
Verified August 2008 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : August 26, 2008
Last Update Posted : August 26, 2008
Sponsor:
Information provided by:
Yonsei University

Brief 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.

Condition or disease
Glaucoma Myopia

Detailed 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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Corrected Measurement of the Retinal Nerve Fiber Layer Thickness by Optic Disc Configuration With the Cirrus HD OCT
Study Start Date : July 2008
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
C
normal volunteers
G
glaucoma patients



Primary Outcome Measures :
  1. the Cirrus HD OCT [ Time Frame: when the OCT images are taking ]

Secondary Outcome Measures :
  1. automated visual field [ Time Frame: when the OCT images are taking ]
  2. red-free fundus photo [ Time Frame: when the OCT images are taking ]
  3. refractive errors [ Time Frame: when the OCT images are taking ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers of our opthalmologic clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741130


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
Study Chair: Gong Je Seong, MD, PhD Yonsei University

Responsible Party: Gong Je Seong, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT00741130     History of Changes
Other Study ID Numbers: 3-2008-0076
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: August 2008

Keywords provided by Yonsei University:
retinal nerve fiber layer
optic nerve head
Cirrus OCT