This trial is active, not recruiting.

Condition uveitis
Sponsor Oregon Health and Science University
Start date March 2012
End date December 2015
Trial size 30 participants
Trial identifier NCT02026128, OHSU IRB#00008052


Optical Coherence Tomography (OCT) machines are non-contact instruments that can provide micrometer (one one-thousandths) scale imaging of biological tissue. This allows excellent assessment of the white blood and inflammatory cells seen in uveitis, an inflammation of any or all parts of the uvea (iris, ciliary body, choroid).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Physician-confirmed diagnosis of uveitis of any origin.

Primary Outcomes

Patients with active uveitis from any disease process
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years of age and older - With one or more of the following clinical features: 1. >1+ AC cells; 2. >1+ vitreous haze; 3. presence of vitreous cells. - In one of the following diagnostic categories as determined by a uveitis specialists: 1. uveitis due to ankylosing spondylitis (positive HLA B27 genotype); 2. uveitis due to sarcoidosis; 3. uveitis of any additional type. Exclusion Criteria: - Inability to give informed consent; - Inability to maintain stable fixation for OCT imaging.

Additional Information

Official title Objective Grading of Intraocular Inflammation in Uveitis Using Optical Coherence Tomography
Principal investigator James Rosenbaum, MD
Description In uveitis, white blood and inflammatory cells can enter the anterior chamber of the eye and adhere to the back surface of the cornea or enter the space between the lens and the retina in various types of uveitis. Transparency of the clear fluid that fills the space between the cornea and the lens (or between the lens and the retina) can be reduced due to the inflammation reaction of the eye. The amounts of these cells and reduced transparency that are present indicate the level of severity of inflammation. The primary goal of this study is to use OCT to standardize anterior chamber (AC) cell grading. Another goal is to discover whether the size of cells and particles in the AC measured by OCT differs between uveitis diagnostic categories. OCT will also be used to detect protein concentration increases within the clear fluid inside the eye and determine if the concentration increase correlates with findings from the usual slit lamp grading method. Background data including age, sex, medical history, and eye history will be gathered prior to the study/OCT testing visit. Other standard-of-care testing, like visual acuity and slit lamp (biomicroscope) exam will be performed to see if there is evidence of uveitis that meets the inclusion criteria for this study. If so, grading of the eye inflammation will be performed as defined by the Standardization of Uveitis Nomenclature (SUN). Once enrolled in the study, subjects will then undergo OCT testing with the study device to assess AC cells, AC flare (increased protein), keratic precipitates (cells adhered to back surface of cornea), and vitreous cells & haze (increased opacities in vitreous gel). OCT Procedure: The subject will be seated and have their head positioned on a chin rest. They will be asked to look at a target (a lighted spot) while a beam of light scans the front part of the eye. The light is infrared and will not be visible or cause any sensation. A cotton tip swab may be used to help hold the eyelid open temporarily if necessary.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.