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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00741130
First received: August 25, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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
Glaucoma
Myopia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • the Cirrus HD OCT [ Time Frame: when the OCT images are taking ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • automated visual field [ Time Frame: when the OCT images are taking ] [ Designated as safety issue: No ]
  • red-free fundus photo [ Time Frame: when the OCT images are taking ] [ Designated as safety issue: No ]
  • refractive errors [ Time Frame: when the OCT images are taking ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
C
normal volunteers
G
glaucoma patients

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.

  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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 College of Medicine
  More Information

No publications provided

Responsible Party: Gong Je Seong, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT00741130     History of Changes
Other Study ID Numbers: 3-2008-0076
Study First Received: August 25, 2008
Last Updated: August 25, 2008
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Glaucoma
Myopia
Ocular Hypertension
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on June 17, 2013