A Pilot Study of Functional Optical Coherence Tomography (OCT) for Ocular Imaging - Full Text View

Sponsor:	Montana Compton
Collaborators:	Beckman Laser Institute University of California Irvine Ophthalmology department, University of California,Irvine
Information provided by (Responsible Party):	Montana Compton, 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 Central Retinal Vein Occlusion Branch Retinal Vein Occlusion	Device: OCT

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus age-related macular degeneration early-onset glaucoma X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetic Eye Problems Eye Diseases Glaucoma Macular Degeneration Retinal Disorders

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

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 2012
Estimated Primary Completion Date:	July 2012 (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 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

Study Population

Primary care clinic and community sample.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556114

Locations

United States, California
Beckman Laser Institute, University of California,Irvine
Irvine, California, United States, 02612

Sponsors and Collaborators

Montana Compton

Beckman Laser Institute University of California Irvine

Ophthalmology department, University of California,Irvine

Investigators

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:	October 28, 2011
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 February 12, 2012