Optical Coherence Tomography (OCT) in Uveitis

NCT ID: NCT02026128

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2025-12-31

Brief 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).

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.

Conditions

Uveitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Active Uveitis

Physician-confirmed diagnosis of uveitis of any origin.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

David Huang

David Huang, MD, PhD, Professor of Ophthalmology & Director of Research, Casey Eye Institute OHSU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Denny Romfh, OD

Role: CONTACT

romfhd@ohsu.edu

503-494-4351

Humberto Martinez, COT

Role: CONTACT

martinhu@ohsu.edu

503-494-7712

Facility Contacts

Denny Romfh, OD

Role: primary

romfhd@ohsu.edu

503-494-4351

Humberto Martinez, COT

Role: backup

martinhu@ohsu.edu

503-494-7712

Other Identifiers

OHSU IRB#00008052

Identifier Type: -

Identifier Source: org_study_id