Optical Coherence Tomography (OCT) in Uveitis

Uveitis Clinical Trial

Official title:

Objective Grading of Intraocular Inflammation in Uveitis Using Optical Coherence Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02026128
• Other study ID #: OHSU IRB#00008052
• Status: Recruiting
• Start date: March 2012
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: Denny Romfh, OD
• Phone: 503-494-4351
• Email: romfhd[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

4. presence of blood in anterior chamber;

5. presence of blood in vitreous;

6. presence of aqueous or vitreous pigment.

• 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;

4. uveitis masquerade such as pigment dispersion syndrome or Schaffer's sign;

5. hyphema due to trauma or other causes;

6. vitreous hemorrhage;

7. retinal tear.

Exclusion Criteria:

• Inability to give informed consent;

• Inability to maintain stable fixation for OCT imaging.

Related Conditions & MeSH terms

• Uveitis

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Primary	Number of keratic precipitates (KP)	KPs will be identified from OCT images by computer algorithms. KPs will be measured in particles.	1 month
Primary	Number of vitreous cells	Vitreous cells will be identified from OCT images by computer algorithms. Vitreous cells will be measured in particles.	1 month
Primary	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.	1 month