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A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging

This study has been completed.
Sponsor:
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
First received: November 7, 2007
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

At Beckman Laser Institute, University of California, Irvine, the investigators have developed diagnostic device call 'optical coherence tomography' The imaging technique used in clinical ophthalmology during eye examination, which is imaging the eye, 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: Optical Coherence Tomography

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:


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 ]

Enrollment: 23
Study Start Date: January 2007
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Optical Coherence Tomography
Optical Coherence Tomography
Device: Optical Coherence Tomography
Optical Coherence Tomography

Detailed Description:

Optical Coherence Tomography is a non-invasive technique that provides high-resolution cross-sectional images of the retina at unprecedented resolutions as small as a few microns. Optical Coherence Tomography 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 Ophthalmology outpatient during their routine visit and will have eye imaging at 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. Optical Coherence Tomography 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
eye exam
Retina

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Degeneration
Retinal Vein Occlusion
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Embolism and Thrombosis
Endocrine System Diseases
Eye Diseases
Retinal Degeneration
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis

ClinicalTrials.gov processed this record on November 24, 2014