The Performances of Spectral Domain Optical Coherence Tom... | NCT01067482

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Feb 10, 2010

First Submission Date that Met QC Criteria

Feb 10, 2010

First Posted Date

Feb 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2010

Last Update Posted Date

Mar 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weerawat Kiddee, MD	Prince of Songkla University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University		Hat Yai	Songkhla, Thailand.	90110	Thailand

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Glaucoma patients
Glaucoma suspect group
Normal population

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension