Normative Database of the Retinal Nerve Fiber Layer Thick... | NCT00744705

Studies
Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians

NCT00744705

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Sep 1, 2008Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Glaucoma

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

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Nov 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Aug 29, 2008

First Submission Date that Met QC Criteria

Aug 29, 2008

First Posted Date

Sep 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 29, 2008

Last Update Posted Date

Sep 1, 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 normal range of retinal nerve fiber layer thickness might be different between Asians and Caucasians. However, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. So, the investigators want to find its normal range of in Asians.

Detailed Description

Characteristics of various ocular parameters are influenced by race. Because the retinal nerve fiber layer (RNFL) thickness is crucial in detecting early glaucomatous changes, its normal range is also important. Even though the normal range of RNFL thickness might be different according to race, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. In the present study, we want to measure the RNFL thickness using the Cirrus HD OCT in normal Asian eyes and to determine its normal range in Asians.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Normal subjects who received routine health check-up in a comprehensive medical testing center

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal nerve fiber layer thickness		when the OCT images are taking

Secondary Outcomes

Measure	Description	Time Frame
Refractive errors		when the OCT images are taking
Intraocular pressure		when the OCT images are taking

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal subjects
Good quality of the OCT images (signal intensity > 8)

Exclusion Criteria:

Any ocular history
DM

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Normal subjects who recieved a regular medical check-up in a comprehensive medical testing center of our institute

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gong Je Seong, MD, PhD	Contact	82-2-2019-3441		gjseong@yuhs.ac

Overall Officials

Name	Affiliation	Role
Gong Je Seong, MD, PhD	Yonsei University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yongdong Severance Hospital, Yonsei University College of Medicine		Seoul		135-720	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D009216	Myopia

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D012030	Refractive Errors

Browse Leaves

Not provided

Browse Branches

Not provided