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Ocular Imaging With Spectral Domain Optical Coherence Tomography

Primary Purpose

Healthy, Myopia, Hypermetropia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring spectral domain-OCT, macular thickness, myopia, hypermetropia, normal

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Yonsei University College of Medicine, Gangnam Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

spectral domain-OCT

Arm Description

Spectral domain-OCT scanning performed.

Outcomes

Primary Outcome Measures

macular retinal thickness and volume

Secondary Outcome Measures

Full Information

First Posted
May 6, 2009
Last Updated
June 19, 2009
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT00926549
Brief Title
Ocular Imaging With Spectral Domain Optical Coherence Tomography
Official Title
Posterior and Anterior Ocular Imaging With Spectral Domain Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Myopia, Hypermetropia
Keywords
spectral domain-OCT, macular thickness, myopia, hypermetropia, normal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
spectral domain-OCT
Arm Type
Experimental
Arm Description
Spectral domain-OCT scanning performed.
Intervention Type
Device
Intervention Name(s)
Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)
Other Intervention Name(s)
Cirrus™ HD-OCT, Carl Zeiss Meditec AG
Intervention Description
macular cube scanning
Primary Outcome Measure Information:
Title
macular retinal thickness and volume
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Soo Kim, MD, PhD
Phone
82-2-2019-3443
Email
semekim@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Won Kyung Song, MD
Phone
82-2-2228-3591
Email
songwk@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Soo Kim, MD, PhD
Organizational Affiliation
Department of Ophthalmology, Yonsei University College of Medicine, Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University College of Medicine, Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Soo Kim, MD, PhD
Phone
82-2-2019-3443
Email
semekim@naver.com
First Name & Middle Initial & Last Name & Degree
Won Kyung Song, MD
Phone
82-2-2228-3591
Email
songwk@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Sung Soo Kim, MD, PhD

12. IPD Sharing Statement

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Ocular Imaging With Spectral Domain Optical Coherence Tomography

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