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CEI Van Outreach Screening Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01510392
First received: January 3, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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).


Condition Intervention
Glaucoma
Macular Disease
Keratoconus
 Device: OCT imaging, the FDA Cleared iVue

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Evaluation of Optical Coherence Tomography Usage in the Screening of Eye Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510392

Locations
United States, Oregon
Casey Eye Institute Outreach Screening Van
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Eye Institute (NEI)
Investigators
Principal Investigator: Michael Chiang, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: David Huang, Michael Chiang, MD, Professor, Provisional, Department of Ophthalmology and Medical Informatics & Clinical Epidemiology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01510392     History of Changes
Other Study ID Numbers: OHSU IRB#00008034-Outreach
Study First Received: January 3, 2012
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Optical coherence tomography
Glaucoma
Macula
Keratoconus
Screening

Additional relevant MeSH terms:
Glaucoma
Keratoconus
Ocular Hypertension
Eye Diseases
Corneal Diseases

ClinicalTrials.gov processed this record on May 19, 2013