An observational study in Uveitis, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by Oregon Health and Science University · Observational
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).
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.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's planned enrollment of 75 is below the median of 107 across 104 observational studies indexed under Uveitis.
Browse Uveitis studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study will enroll both males and females and include all ethnic and racial groups through clinical practices. The study will enroll subjects 18 years of age or older with physician-confirmed, active uveitis. A total of thirty subjects will be recruited.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
With one or more of the following clinical features:
In one of the following diagnostic categories as determined by a uveitis specialists:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physician-confirmed diagnosis of uveitis of any origin.
Number of anterior chamber cells
Anterior chamber cells will be identified from OCT images by computer algorithms. Anterior chamber cells will be measured in particles.
Time frame: 1 month
Number of keratic precipitates (KP)
KPs will be identified from OCT images by computer algorithms. KPs will be measured in particles.
Time frame: 1 month
Number of vitreous cells
Vitreous cells will be identified from OCT images by computer algorithms. Vitreous cells will be measured in particles.
Time frame: 1 month
Degree of anterior chamber flare
OCT signal of the aqueous humor will be analyzed and correlated with slit lamp grades on AC flare. AC flare will be measured in a.u.
Time frame: 1 month
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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