CEI Van Outreach Screening Study

NCT ID: NCT01510392

Last Updated: 2018-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-02-02

Brief Summary

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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

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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.

Conditions

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Glaucoma Macular Disease Keratoconus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Huang

Michael Chiang, MD, Professor, Provisional, Department of Ophthalmology and Medical Informatics & Clinical Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Chiang, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Casey Eye Institute Outreach Screening Van

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OHSU IRB#00008034-Outreach

Identifier Type: -

Identifier Source: org_study_id

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