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Ocular Imaging With Spectral Domain Optical Coherence Tomography

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ClinicalTrials.gov Identifier: NCT00926549
Recruitment Status : Unknown
Verified June 2009 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : June 23, 2009
Last Update Posted : June 23, 2009
Sponsor:
Information provided by:
Yonsei University

Tracking Information
First Submitted Date  ICMJE May 6, 2009
First Posted Date  ICMJE June 23, 2009
Last Update Posted Date June 23, 2009
Study Start Date  ICMJE May 2009
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2009)
macular retinal thickness and volume [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ocular Imaging With Spectral Domain Optical Coherence Tomography
Official Title  ICMJE Posterior and Anterior Ocular Imaging With Spectral Domain Optical Coherence Tomography
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Healthy
  • Myopia
  • Hypermetropia
Intervention  ICMJE Device: Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)
macular cube scanning
Other Name: Cirrus™ HD-OCT, Carl Zeiss Meditec AG
Study Arms  ICMJE Experimental: spectral domain-OCT
Spectral domain-OCT scanning performed.
Intervention: Device: Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 19, 2009)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2009
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00926549
Other Study ID Numbers  ICMJE 3-2008-0048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sung Soo Kim, Department of Ophthalmology, Gangnam Severance Hospital
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sung Soo Kim, MD, PhD Department of Ophthalmology, Yonsei University College of Medicine, Gangnam Severance Hospital
PRS Account Yonsei University
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP