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| Sponsors and Collaborators: |
University of California, Irvine Beckman Laser Institute University of California Irvine Ophthalmology department, University of California,Irvine |
|---|---|
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00556114 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma Diabetic Retinopathy Age-Related Macular Degeneration |
Device: OCT |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 |
Device: OCT
OCT eye exam imaging
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Primary care clinic and community sample.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Beckman Laser Institute, University of California,Irvine | |
| Irvine, California, United States, 02612 | |
| Principal Investigator: | Baruch D Kuppermann,, M.D., Ph.D. | Ophthamology, University of California,Irvine |
| Principal Investigator: | Zhongping Chen, Ph,D | Beckman Laser Institute University of California Irvine |
More Information
| Responsible Party: | Beckman Laser Institute ( Baruch D. Kuppermann,, M.D., Ph.D. ) |
| Study ID Numbers: | NIH OCT EB-093-07, LAMMP NIH |
| Study First Received: | November 7, 2007 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00556114 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
eye exam Retina |
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Eye Diseases Vascular Diseases Diabetes Mellitus Macular Degeneration Endocrine System Diseases Retinal Degeneration Diabetic Angiopathies |
Diabetic Retinopathy Glaucoma Endocrinopathy Retinal Diseases Diabetes Complications Ocular Hypertension Hypertension |
|
Eye Diseases Vascular Diseases Diabetes Mellitus Macular Degeneration Endocrine System Diseases Retinal Degeneration Diabetic Angiopathies |
Diabetic Retinopathy Glaucoma Cardiovascular Diseases Retinal Diseases Diabetes Complications Ocular Hypertension |
