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Completed

NCT Number: NCT01510392

CEI Van Outreach Screening Study

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).

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Key information

Conditions

Glaucoma Corneal Diseases Eye Diseases Keratoconus Macular Degeneration Macular Disease Ocular Hypertension Retinal Degeneration Retinal Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Casey Eye Institute Outreach Screening Van

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT imaging, the FDA Cleared iVue

Device

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.

Primary outcomes

  1. OCT screening efficacy for detection of early stage eye diseases in comparison to the current standard of care methods

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 16, 2012
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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