CEI Van Outreach Screening Study

Completed

• Conditions: Macular Disease; Keratoconus; Glaucoma

• Registration Number: NCT01510392
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-16
• Primary Completion: 2017-02-02
• Study Completion: 2017-02-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Casey Eye Institute Outreach Screening Van; 🇺🇸 Portland, Oregon, United States