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A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging (OCT)

This study is enrolling participants by invitation only.

Sponsors and Collaborators: University of California, Irvine
Beckman Laser Institute Medical Clinic
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, we 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 disease,including choroidal, and 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 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

Genetics Home Reference related topics:   Glaucoma  

MedlinePlus related topics:   Diabetic Eye Problems   Glaucoma   Macular Degeneration  

ChemIDplus related topics:   Tretinoin  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging

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

Biospecimen Retention:   None Retained

Biospecimen Description:

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

Detailed Description:

OCT is 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 require 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 use to imaging and will takes from 0.32 seconds to 1.92 seconds to be acquired, then 5-10 seconds to be displayed and 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 cummunity sample.


Criteria

Inclusion Criteria:

  • Adult 18 years and older with normal eye or has diagnose 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
University of California, Irvine
Beckman Laser Institute Medical Clinic
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 Medical Clinic    
  More Information

Responsible Party:   Beckman Laser Institute ( Baruch D. Kuppermann,, M.D., Ph.D. )
Study ID Numbers:   RR-01192;PHS- NIH, P41-RR01192;NIH-LAMMP
First Received:   November 7, 2007
Last Updated:   January 2, 2008
ClinicalTrials.gov Identifier:   NCT00556114
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Vascular Diseases
Diabetes Mellitus
Macular Degeneration
Retinal Degeneration
Diabetic Angiopathies
Diabetic Retinopathy
Glaucoma
Tretinoin
Endocrinopathy
Retinal Diseases
Diabetes Complications
Ocular Hypertension
Hypertension
Retinal degeneration

Additional relevant MeSH terms:
Eye Diseases
Endocrine System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 15, 2008