CEI Van Outreach Screening Study

NCT01510392 | Completed DMC

• 1 other identifier: OHSU IRB#00008034-Outreach
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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).

Conditions

Glaucoma; Macular Disease; Keratoconus

Keywords

Optical coherence tomography; Glaucoma; Macula; Keratoconus; Screening

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be performed enrolling participants from the Casey Eye Institute outreach van.

You may qualify if:

• Participant undergoing a screening examination at the Casey Eye Institute Outreach Van.
• Participants must be between the ages of 18 and 89 years old.

You may not qualify if:

• Inability to give informed consent.
• Inability to maintain stable fixation for OCT imaging

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Casey Eye Institute Outreach Screening Van

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Glaucoma; Macular Degeneration; Keratoconus

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Retinal Degeneration; Retinal Diseases; Corneal Diseases

Study Officials

• Michael Chiang, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael Chiang, MD, Professor, Provisional, Department of Ophthalmology and Medical Informatics & Clinical Epidemiology

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 16, 2012
• Study Start: January 1, 2012
• Primary Completion: February 2, 2017
• Study Completion: February 2, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (1)