CEI Van Outreach Screening Study

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01510392
• Collaborator: National Eye Institute (NEI) (NIH)
• Enrollment: 118
• Location: 1
• Duration (Months): 61.1
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Macular Disease; Keratoconus	Device: OCT imaging, the FDA Cleared iVue

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 Design

• Study Type: Observational
• Actual Enrollment: 118 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Prospective Evaluation of Optical Coherence Tomography Usage in the Screening of Eye Diseases
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Feb 2, 2017
• Actual Study Completion Date: Feb 2, 2017

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
• Other Study ID Numbers: OHSU IRB#00008034-Outreach
• First Posted: Jan 16, 2012
• Last Update Posted: Apr 12, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by David Huang, Michael Chiang, MD, Professor, Provisional, Department of Ophthalmology and Medical Informatics & Clinical Epidemiology, Oregon Health and Science University: Optical coherence tomography; Glaucoma; Macula; Keratoconus; Screening
• Additional relevant MeSH terms: Glaucoma; Keratoconus

Study Results

No Results Posted as of Apr 12, 2018