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Efficacy of Retinal Nerve Fiber Layer (RNFL) / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00772993
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of glaucoma diagnosis and progression.


Condition
Glaucoma
Myopia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Efficacy of RNFL / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Ratio of RNFL / Full thickness retina [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Primary open angle glaucoma
2
Normal Control
3
Myopia with no evidence of glaucoma
4
Myopia with evidence og glaucoma

  Eligibility

Ages Eligible for Study:   10 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

prospective consecutive recruitment from a tertialry glaucoma subspecialty practise

Criteria

Inclusion Criteria:

  • Primary open angle glaucoma
  • Myopia
  • Myopia with evidence of glaucoma
  • Normal controls

Exclusion Criteria:

  • Evidence of retinal disease
  • BCVA < 0.4
  • Secondary glaucoma due to intraocular inflammation
  • Lens induced glaucoma
  • Tumor induced glaucoma
  • Neovascular glaucoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772993

Contacts
Contact: Chan Yun Kim, MD,PhD. 82-2-2228-3570 kangeye@hotmail.com
Contact: Sung Yong Kang, MD 82-2-2228-3570 kangeye@yuhs.ac

Locations
Korea, Republic of
Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University School of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Chan Yun Kim, MD,PhD     82-2-2228-3570     kangeye@hotmail.com    
Principal Investigator: Chan Yun Kim, MD,PhD.            
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Kim Chan Yun, Institute of Vision Research, Department of Ophthalmology, Yonsei University School of Medicine, Severance Hospital.
ClinicalTrials.gov Identifier: NCT00772993     History of Changes
Other Study ID Numbers: 4-2008-0340
Study First Received: October 15, 2008
Last Updated: October 15, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
glaucoma
myopia
myopia with glaucoma
normal control

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

ClinicalTrials.gov processed this record on June 18, 2013