Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With the Cirrus High-Definition (HD) Optical Coherence Tomography (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  Not yet recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00742196
First received: August 26, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary atrophy.


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With

Resource links provided by NLM:


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 ]
  • Size of parapapillary atrophy [ Time Frame: when the OCT images are taking ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
No parapapillary atrophy
2
Parapapillary atrophy

Detailed Description:

Recently, the retinal nerve fiber layer (RNFL) thickness measurement using the optical coherence tomography (OCT) becomes very useful to detect such a glaucomatous damage. However, there are some difficult cases including parapapillary atrophy to perform this measurement. Because the RNFL thickness is so sensitive to the position of measurement and the measurement of RNFL thickness on parapapillary atrophy is incorrect, it is difficult to determine exact RNFL thickness in patients with a large parapapillary atrophy. In the present study, we want to find the proper method to analyze the RNFL thickness on parapapillary atrophy. The previous OCT used a fixed circle to measure the RNFL thickness, but the new spectral domain OCT, the Cirrus HD OCT, uses a movable one. Therefore, we may suggest a new analysis strategy for the parapapillary atrophy.

  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

Subjects with or without parapapillary atrophy

Criteria

Inclusion Criteria:

  • Qualified OCT images (signal strength > or = 8)

Exclusion Criteria:

  • Previous intraocular surgery history
  • Media opacity
  • DM
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742196

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

Locations
Korea, Republic of
Gong Je Seong Not yet 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
  More Information

No publications provided

Responsible Party: Gong Je Seong, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT00742196     History of Changes
Other Study ID Numbers: 3-2008-0076-2
Study First Received: August 26, 2008
Last Updated: August 26, 2008
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Glaucoma
Atrophy
Ocular Hypertension
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014