The Performances of Spectral Domain Optical Coherence Tomography (OCT) for Distinguishing Glaucomatous Eyes - Tabular View

Tracking Information

First Received Date ^ICMJE

February 10, 2010

Last Updated Date

March 22, 2010

Start Date ^ICMJE

September 2009

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT01067482 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Performances of Spectral Domain Optical Coherence Tomography (OCT) for Distinguishing Glaucomatous Eyes

Official Title ^ICMJE

The Performances of Spectral Domain Optical Coherence Tomography for Distinguishing Between Normal Eyes, Glaucoma Suspect and Glaucomatous Eyes

Brief Summary

The purpose of this study is to evaluate performances of each parameters of spectral domain (Cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma suspect and glaucomatous eyes

Detailed Description

Aim to determine which parameter of cirrus OCT is best sensitivity and specificity for glaucoma detection

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Biospecimen

Sampling Method

Probability Sample

Study Population

glaucoma patient from glaucoma clinic that is POAG Glaucoma suspect cases normal population case

Condition ^ICMJE

Glaucoma Patient
Glaucoma Suspect Patient
Normal Population
RNFL Thickness by Location
Macular Thickness by Location

Intervention ^ICMJE

Comparison Groups

Glaucoma patients
Glaucoma suspect group
Normal population

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

BCVA at least 20/60
refractive error +/- 5 D Or astig +/- 3 D
enrolled in 3 population group (glaucoma, glaucoma suspect or normal)

Exclusion Criteria:

VA less than 20/60
marked RF error
previous ocular trauma or surgery
unreliable visual field
poor signal cirrus OCT (less than 7)
other causes of optic nerve or macular disease other than glaucoma

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01067482

Other Study ID Numbers ^ICMJE

EC 52-336-02-1-2

Has Data Monitoring Committee

Yes

Responsible Party

Weerawat Kiddee, Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University Hat-yai,, Songkhla, Thailand., Thailand

Study Sponsor ^ICMJE

Prince of Songkla University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Weerawat Kiddee, MD

Prince of Songkla University

Information Provided By

Prince of Songkla University

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP