A Pilot Study of Functional Optical Coherence Tomography (OCT) for Ocular Imaging
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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 Central Retinal Vein Occlusion Branch Retinal Vein Occlusion |
Device: OCT for ocular imaging |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging |
- imaging technique of the retina and ability to diagnose and manage many eye diseases [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
eye exam
Major causes of vision loss that have a vascular component.
|
Device: OCT for ocular imaging
OCT eye exam imaging
|
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 Subjects will be recruited from UCIMC Ophthalmology outpatient during their routine visit and will have eye imaging at UCI Beckman laser institute. 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:
- Adult 18 years and older with normal eye, or has been diagnosed with eye disease.
Exclusion Criteria:
- Less than 18 years of age.
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
No publications provided
| Responsible Party: | Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00556114 History of Changes |
| Other Study ID Numbers: | D/EB-00293-07, LAMMP |
| Study First Received: | November 7, 2007 |
| Last Updated: | December 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
eye exam Retina |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Glaucoma Macular Degeneration Retinal Diseases Retinal Vein Occlusion Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases Ocular Hypertension Retinal Degeneration Venous Thrombosis Thrombosis Embolism and Thrombosis |
ClinicalTrials.gov processed this record on May 21, 2013