CEI Van Outreach Screening Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01510392
First received: January 3, 2012
Last updated: August 29, 2014
Last verified: August 2014

January 3, 2012
August 29, 2014
January 2012
December 2015   (final data collection date for primary outcome measure)
OCT screening efficacy for detection of early stage eye diseases in comparison to the current standard of care methods [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The primary goal of the trial is to show that OCT technology, specifically the FDA cleared iVue, can be used to effectively screen for glaucoma, macular diseases and keratoconus. The rate of detection of these diseases detected using OCT will be compared to the rate of detection by the physician's exam.
Same as current
Complete list of historical versions of study NCT01510392 on ClinicalTrials.gov Archive Site
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CEI Van Outreach Screening Study
Prospective Evaluation of Optical Coherence Tomography Usage in the Screening of Eye Diseases

The primary goal of the trial is to show that optical coherence tomography (OCT) technology can be used to effectively screen for diseases of the eye including glaucoma, macular diseases and keratoconus. Glaucoma is a disease that causes permanent vision loss and is usually accompanied by increased eye pressure. Macular diseases affect sharp, central vision. Keratoconus is a disease that affects the cornea (clear surface covering the colored part of the eye).

The identification of many eye diseases would significantly benefit from earlier detection than is available with typical eye exams. Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of tissue structure in real time. It is similar to ultrasound B-mode imaging, except that OCT measures the intensity of reflected light rather than sound waves.

Observational
Time Perspective: Prospective
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Non-Probability Sample

This study will be performed enrolling participants from the Casey Eye Institute outreach van.

  • Glaucoma
  • Macular Disease
  • Keratoconus
Device: OCT imaging, the FDA Cleared iVue
The OCT system scans a beam of light across the eye to take a picture. OCT imaging does not touch the eye. This is a test that is performed using an FDA approved system, and is regularly used to take pictures of the back of the eye.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant undergoing a screening examination at the Casey Eye Institute Outreach Van.
  • Participants must be between the ages of 18 and 89 years old.

Exclusion Criteria:

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging
Both
18 Years to 89 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01510392
OHSU IRB#00008034-Outreach
Yes
David Huang, Oregon Health and Science University
Oregon Health and Science University
National Eye Institute (NEI)
Principal Investigator: Michael Chiang, MD Oregon Health and Science University
Oregon Health and Science University
August 2014

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