CEI Van Outreach Screening Study

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510392
• Other study ID #: OHSU IRB#00008034-Outreach
• Status: Completed
• First received: January 3, 2012
• Last updated: April 10, 2018
• Start date: January 2012
• Est. completion date: February 2, 2017

Study information

• Verified date: April 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Keratoconus
• Macular Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Casey Eye Institute Outreach Screening Van	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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