- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02026128
Optical Coherence Tomography (OCT) in Uveitis
Objective Grading of Intraocular Inflammation in Uveitis Using Optical Coherence Tomography
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Denny Romfh, OD
- Phone Number: 503-494-4351
- Email: romfhd@ohsu.edu
Study Contact Backup
- Name: Humberto Martinez, COT
- Phone Number: 503-494-7712
- Email: martinhu@ohsu.edu
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
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Contact:
- Denny Romfh, OD
- Phone Number: 503-494-4351
- Email: romfhd@ohsu.edu
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Sub-Investigator:
- Eric Suhler, MD
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Contact:
- Humberto Martinez, COT
- Phone Number: 503-494-7712
- Email: martinhu@ohsu.edu
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Sub-Investigator:
- Yan Li, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age and older
With one or more of the following clinical features:
- >1+ AC cells;
- >1+ vitreous haze;
- presence of vitreous cells;
- presence of blood in anterior chamber;
- presence of blood in vitreous;
- presence of aqueous or vitreous pigment.
In one of the following diagnostic categories as determined by a uveitis specialists:
- uveitis due to ankylosing spondylitis (positive HLA B27 genotype);
- uveitis due to sarcoidosis;
- uveitis of any additional type;
- uveitis masquerade such as pigment dispersion syndrome or Schaffer's sign;
- hyphema due to trauma or other causes;
- vitreous hemorrhage;
- retinal tear.
Exclusion Criteria:
- Inability to give informed consent;
- Inability to maintain stable fixation for OCT imaging.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Active Uveitis
Physician-confirmed diagnosis of uveitis of any origin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of anterior chamber cells
Time Frame: 1 month
|
Anterior chamber cells will be identified from OCT images by computer algorithms.
Anterior chamber cells will be measured in particles.
|
1 month
|
Number of keratic precipitates (KP)
Time Frame: 1 month
|
KPs will be identified from OCT images by computer algorithms.
KPs will be measured in particles.
|
1 month
|
Number of vitreous cells
Time Frame: 1 month
|
Vitreous cells will be identified from OCT images by computer algorithms.
Vitreous cells will be measured in particles.
|
1 month
|
Degree of anterior chamber flare
Time Frame: 1 month
|
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.
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHSU IRB#00008052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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