- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00772993
Efficacy of Retinal Nerve Fiber Layer (RNFL) / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma
October 15, 2008 updated by: Yonsei University
Efficacy of RNFL / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
prospective consecutive recruitment from a tertialry glaucoma subspecialty practise
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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1
Primary open angle glaucoma
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2
Normal Control
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3
Myopia with no evidence of glaucoma
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4
Myopia with evidence og glaucoma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Ratio of RNFL / Full thickness retina
Time Frame: 2 months
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2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Anticipated)
December 1, 2008
Study Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
October 15, 2008
First Submitted That Met QC Criteria
October 15, 2008
First Posted (Estimate)
October 16, 2008
Study Record Updates
Last Update Posted (Estimate)
October 16, 2008
Last Update Submitted That Met QC Criteria
October 15, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2008-0340
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.