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

November 7, 2007
December 9, 2013
January 2007
July 2013   (final data collection date for primary outcome measure)
imaging technique of the retina and ability to diagnose and manage many eye diseases [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00556114 on ClinicalTrials.gov Archive Site
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A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging
A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Primary care clinic and community sample.

  • Glaucoma
  • Diabetic Retinopathy
  • Age-Related Macular Degeneration
  • Central Retinal Vein Occlusion
  • Branch Retinal Vein Occlusion
Device: Optical Coherence Tomography
Optical Coherence Tomography
Optical Coherence Tomography
Optical Coherence Tomography
Intervention: Device: Optical Coherence Tomography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00556114
D/EB-00293-07, LAMMP
No
Montana Compton, University of California, Irvine
Montana Compton
  • Beckman Laser Institute University of California Irvine
  • Ophthalmology department, University of California,Irvine
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
University of California, Irvine
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP