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CEI Van Outreach Screening Study

Prospective Evaluation of Optical Coherence Tomography Usage in the Screening of Eye Diseases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01510392
Enrollment
118
Registered
2012-01-16
Start date
2012-01-31
Completion date
2017-02-02
Last updated
2018-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Keratoconus, Macular Disease

Keywords

Optical coherence tomography, Glaucoma, Macula, Keratoconus, Screening

Brief summary

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).

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.

Interventions

DEVICEOCT 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.

Sponsors

National Eye Institute (NEI)
CollaboratorNIH
Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
OCT screening efficacy for detection of early stage eye diseases in comparison to the current standard of care methods1 yearThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026