|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 7, 2007 | ||||||||
| Last Updated Date | March 13, 2009 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00556114 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Pilot Study of Functional Optical Coherence Tomography (OCT) for Ocular Imaging | ||||||||
| Official Title ICMJE | A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging | ||||||||
| Brief Summary | At Beckman Laser Institute, University of California, Irvine, the investigators have developed diagnostic device call 'optical coherence tomography (OCT).' The imaging technique used in clinical ophthalmology during eye examination, which is imaging the eye (retina), and to diagnose and manages many eye diseases. The study is used to diagnose and manage retinal diseases, including choroidal, optic nerve head vessels in macular degeneration, vitreomacular traction syndrome, diabetic retinopathy, retinoschisis, macular edema, central serous chorioretinopathy, optic nerve disorders, and nerve fiber layer evaluation in glaucoma, and to compare these to normal controls. Growing evidence shows that altered blood flow plays a major role in many vision-threatening diseases, although they account for the majority of cases of severe vision loss and blindness in the United States and worldwide. |
||||||||
| Detailed Description | OCT is a non-invasive technique that provides high-resolution cross-sectional images of the retina at unprecedented resolutions as small as a few microns. OCT uses a broadband light source to illuminate the area of study with light in the near infrared spectrum, then obtains static images of tissue structure from interference signals of the back-reflected light. The subject is required to look into an eyepiece on the exam device at a green blinking fixation light illuminated on a dimly lighted background. OCT non-invasive technique takes from 0.32 seconds to 1.92 seconds for the image to be acquired, then 5-10 seconds to be displayed and to determine if the image quality is sufficient. Approximated 4-5 images are taken. |
||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Prospective | ||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Device: OCT | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00556114 | ||||||||
| Responsible Party | Baruch D. Kuppermann,, M.D., Ph.D., Beckman Laser Institute | ||||||||
| Study ID Numbers ICMJE | NIH OCT EB-093-07, LAMMP NIH | ||||||||
| Study Sponsor ICMJE | University of California, Irvine | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of California, Irvine | ||||||||
| Verification Date | March 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
