Anterior Uveitis (AU)NCT07065747
Quantification & Classification of Inflammatory Cells in Uveitis Using OCT
An observational study of Anterior Uveitis (AU) and Birdshot Chorioretinitis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this study is to determine if it's possible to use a high resolution imaging device called optical coherence tomography (OCT) to develop an unbiased, standard method of counting and categorizing the various types of cells and proteins found in an eye condition called anterior uveitis. Read more about this study
- Who is it for?
- Ages 5 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Uveitis (AU), Birdshot Chorioretinitis, Behcet Disease
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study participants will be recruited from clinical practices of the investigators at Casey Eye Institute of Oregon Health \& Science University in Portland, Oregon.
Who may be able to join
- Uveitis Group: Eyes with active intraocular inflammation and a clinical diagnose of spondyloarthritis/HLA-B27 associated anterior uveitis, Juvenile Idiopathic Arthritis (JIA) associated chronic anterior uveitis, Herpes Simplex Virus (HSV) anterior uveitis, Birdshot chorioretinitis, Behcet disease uveitis, sarcoidosis associated uveitis, uveitis of any additional type, or uveitis masquerade.
- Posterior Vitreous Detachment Group: Eyes with vitreous floaters and posterior vitreous detachment (PVD).
- Healthy/Control Group: Healthy eyes with no history of uveitis, PVD, or previous eye surgery.
Who cannot join
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging.
- Inability to commit to required visits to complete the study.
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Casey Eye Institute - Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Objective Grading of Intraocular Inflammation in Uveitis Using Optical Coherence Tomography
The goal of this study is to determine if it's possible to use a high resolution imaging device called optical coherence tomography (OCT) to develop an unbiased, standard method of counting and categorizing the various types of cells and proteins found in an eye condition called anterior uveitis. Anterior uveitis is a type of inflammation in the eye that can be caused by many different diseases of the body.
- Conditions
- Anterior Uveitis (AU), Birdshot Chorioretinitis, Behcet Disease, Herpes Simplex Virus, Juvenile Idiopathic Arthritis (JIA), Spondyloarthritis (SA)
- Medical subject headings
- Uveitis, Anterior, Birdshot Chorioretinopathy, Behcet Syndrome, Herpes Simplex, Arthritis, Juvenile, Spondylarthritis, Sarcoidosis, Vitreous Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Uveitis Group | Eyes with active inflammation due to various systemic diseases | |
| Posterior Vitreous Detachment Group | Eyes with vitreous floaters and posterior vitreous detachment | |
| Healthy/Control Group | Healthy eyes with no history of uveitis, posterior vitreous detachment, or previous eye surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification & Measurement of Anterior Chamber Cells
Anterior Chamber (AC) cells will be identified from OCT images by computer algorithms. AC cell number counted by OCT will be correlated with slit lamp grading. Cell size \& other characteristics identified from OCT images will be associated with different uveitis diagnostic categories. The Standardization of Uveitis Nomenclature (SUN) grading system (scale: 0 = none to 4+ = severe) will be used to compare OCT-derived quantification against slit-lamp grading performed by attending physicians.
Measured: Day 1
Secondary outcomes (4)
Measure of AC Flare
OCT signal of the aqueous humor will be analyzed and correlated with slit lamp grading by the attending physician. The SUN grading system (scale: 0 to 4+) will be used.
Measured: Day 1
Measure of Keratic Precipitates
Keratic precipitates (KPs) will be identified from OCT images. The size of the KPs will be compared across different uveitis diagnostic categories. There is no formal grading system for KPs. The investigators will use the typical qualitative assessments of morphology, distribution, and density. For morphology, cells will be described as fine, mutton-fat, stellate, or pigmented. Distribution patterns will be described as Arlt's Triangle, diffuse, central, or ring-shaped. Density will be described as few, moderate, or numerous.
Measured: Day 1
Measure of Vitreous Cells
Vitreous cells will be identified from OCT images. Counting of vitreous cells will be done by computer algorithms. Since vitreous cells are not formally graded or quantified in the SUN system, physician grading will be described as rare, few, moderate, numerous, or sheets and compared against the OCT-derived measurements.
Measured: Day 1
Measurement of Vitreous Haze
OCT signal of the vitreous clarity will be compared against clinical grading of vitreous haze. The National Eye Institute (NEI) Grading Scale will be used. Grading will be documented on a scale of 0 = no haze to 4+ = severe haze.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Uveitis (AU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Yan Li, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065747
- Sponsor's protocol ID
- OHSU IRB0008052
- Other IDs
- R21EY036563
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Grading of Intraocular Inflammation in Uveitis Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT07065747
- Acronym / sponsor ID
- OHSU IRB0008052
- Conditions
- Anterior Uveitis (AU), Birdshot Chorioretinitis, Behcet Disease, Herpes Simplex Virus, Juvenile Idiopathic Arthritis (JIA), Spondyloarthritis (SA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if it's possible to use a high resolution imaging device called optical coherence tomography (OCT) to develop an unbiased, standard method of counting and categorizing the various types of cells and proteins found in an eye condition called anterior uveitis. Anterior uveitis is a type of inflammation in the eye that can be caused by many different diseases of the body.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Uveitis Group | – | –Eyes with active inflammation due to various systemic diseases |
| Posterior Vitreous Detachment Group | – | –Eyes with vitreous floaters and posterior vitreous detachment |
| Healthy/Control Group | – | –Healthy eyes with no history of uveitis, posterior vitreous detachment, or previous eye surgery |
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be recruited from clinical practices of the investigators at Casey Eye Institute of Oregon Health \& Science University in Portland, Oregon.
Key inclusion criteria (3 listed)
- Uveitis Group: Eyes with active intraocular inflammation and a clinical diagnose of spondyloarthritis/HLA-B27 associated anterior uveitis, Juvenile Idiopathic Arthritis (JIA) associated chronic anterior uveitis, Herpes Simplex Virus (HSV) anterior uveitis, Birdshot chorioretinitis, Behcet disease uveitis, sarcoidosis associated uveitis, uveitis of any additional type, or uveitis masquerade.
- Posterior Vitreous Detachment Group: Eyes with vitreous floaters and posterior vitreous detachment (PVD).
- Healthy/Control Group: Healthy eyes with no history of uveitis, PVD, or previous eye surgery.
Key exclusion criteria (4 listed)
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging.
- Inability to commit to required visits to complete the study.
- Pregnancy and breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification & Measurement of Anterior Chamber Cells
Time frame: Day 1
Anterior Chamber (AC) cells will be identified from OCT images by computer algorithms. AC cell number counted by OCT will be correlated with slit lamp grading. Cell size \& other characteristics identified from OCT images will be associated with different uveitis diagnostic categories. The Standardization of Uveitis Nomenclature (SUN) grading system (scale: 0 = none to 4+ = severe) will be used to compare OCT-derived quantification against slit-lamp grading performed by attending physicians.
4 secondary outcomes
Measure of AC Flare
Time frame: Day 1
Measure of Keratic Precipitates
Time frame: Day 1
Measure of Vitreous Cells
Time frame: Day 1
Measurement of Vitreous Haze
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Li, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Uveitis (AU) and Birdshot Chorioretinitis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Humberto Martinez, COT, MBA (503-494-7712, martinhu@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification & Measurement of Anterior Chamber Cells (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.