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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00772993
• Other study ID #: 4-2008-0340
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2008
• Last updated: October 15, 2008
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: October 2008
• Source: Yonsei University
• Contact: Chan Yun Kim, MD,PhD.
• Phone: 82-2-2228-3570
• Email: kangeye[@]hotmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 90 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Myopia

Locations

Country	Name	City	State
Korea, Republic of	Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of RNFL / Full thickness retina		2 months	No