Screening for Glaucoma in Namil Area, South Korea | NCT00727168

Studies
Screening for Glaucoma in Namil Area, South Korea

NCT00727168

Sponsor

Korean Glaucoma Society

Status

Completed

Last Update Posted

Aug 4, 2008Estimated

Enrollment

1,532Actual

Phase

Not provided

Conditions

Glaucoma
Intraocular Pressure
Optic Nerve Head
Visual Field

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

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

Nov 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Jul 30, 2008

First Submission Date that Met QC Criteria

Jul 30, 2008

First Posted Date

Aug 1, 2008Estimated

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

Aug 1, 2008

Last Update Posted Date

Aug 4, 2008Estimated

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 study the prevalence of glaucoma in Korea, the investigators selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in this area are to be recruited to full ophthalmologic examination to detect and classify the glaucoma.

Detailed Description

Screening includes following examinations; Questionaire and Consent form, Visual acuity test, Auto-refraction, IOL Master measurement, Pachymetry, FDT Perimetry, Fundus Photography, Slit lamp examination, Goldmann applanation Tonometry, Gonioscopy, and Binocular optic disc evaluation. For the cases showing any abnormality in FDT perimetry, optic disc morphology, or intraocular pressure, Humphrey automated visual field test is to be performed as an extended examination. Finally, optic nerve head evaluation by OCT or GDx analyzer is to be used as a confirmation test, as well as additional Humphrey visual field test.

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

1,532Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of glaucoma in Namil area		cross-sectional

Secondary Outcomes

Measure	Description	Time Frame
Clinical factors associated with the glaucoma		cross-sectional

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All residents aged over 40 in Namil area

Exclusion Criteria:

Individuals registered but not actually living in this area

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All residents aged over 40 in Namil area in Geumsan city

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gong-je Seong, MD, PhD	Korean Glaucoma Society	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yongdong Severance Hospital		Seoul		135-720	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22965594	Derived	Kim YY, Lee JH, Ahn MD, Kim CY; Namil Study Group, Korean Glaucoma Society. Angle closure in the Namil study in central South Korea. Arch Ophthalmol. 2012 Sep;130(9):1177-83. doi: 10.1001/archophthalmol.2012.1470.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases