Ocular Imaging With Spectral Domain Optical Coherence Tom... | NCT00926549

Studies
Ocular Imaging With Spectral Domain Optical Coherence Tomography

NCT00926549

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jun 23, 2009Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Healthy
Myopia
Hypermetropia

Interventions

Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Sep 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

May 6, 2009

First Submission Date that Met QC Criteria

Jun 19, 2009

First Posted Date

Jun 23, 2009Estimated

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

Jun 19, 2009

Last Update Posted Date

Jun 23, 2009Estimated

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 analyze macular retinal thickness and macular volume using the spectral domain - optical coherence tomography (SD-OCT) in normal eyes and in eyes with various ocular diseases.

Detailed Description

Assessment of macular thickness is important for the treatment and follow-up of a variety of ocular diseases. The introduction of optical coherence tomography (OCT) has enabled clinicians to reliably detect small changes in macular thickness and to quantitatively evaluate the efficacy of different therapeutic modalities. In this study using the spectral domain-OCT, we examined the variations of macular retinal thickness and macular volume in normal eyes and in eyes with various ocular diseases.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
spectral domain-OCT	Experimental	Spectral domain-OCT scanning performed.	Device: Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)	Device	macular cube scanning	spectral domain-OCT

Measure	Description	Time Frame
macular retinal thickness and volume		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal eyes
myopic eyes
hypermetropic eyes

Exclusion Criteria:

systemic illness
cataract
previous ocular trauma or surgery(other than cataract surgery or refractive surgeries)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sung Soo Kim, MD, PhD	Contact	82-2-2019-3443		semekim@naver.com
Won Kyung Song, MD	Contact	82-2-2228-3591		songwk@yuhs.ac

Overall Officials

Name	Affiliation	Role
Sung Soo Kim, MD, PhD	Department of Ophthalmology, Yonsei University College of Medicine, Gangnam Severance Hospital	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia
D006956	Hyperopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided