UveitisNCT02026128
Optical Coherence Tomography (OCT) in Uveitis
An observational study of Uveitis, run by Oregon Health and Science University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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;
Show all 16Show fewer
- 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.
Who cannot join
- Inability to give informed consent;
- Inability to maintain stable fixation for OCT imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Denny Romfh, OD, 503-494-4351, romfhd@ohsu.edu
Humberto Martinez, COT, 503-494-7712, martinhu@ohsu.edu
About this study
Official title: Objective Grading of Intraocular Inflammation in Uveitis Using Optical Coherence Tomography
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).
Read the 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
- Keywords
- Uveitis, Inflammation, OCT, Grading
- Medical subject headings
- Uveitis, Inflammation
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 |
|---|---|---|
| Active Uveitis | Physician-confirmed diagnosis of uveitis of any origin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Number of keratic precipitates (KP)
KPs will be identified from OCT images by computer algorithms. KPs will be measured in particles.
Measured: 1 month
Number of vitreous cells
Vitreous cells will be identified from OCT images by computer algorithms. Vitreous cells will be measured in particles.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- David Huang, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026128
- Sponsor's protocol ID
- OHSU IRB#00008052
- Status last verified
- Feb 2024
- First submitted
- 30 Dec 2013
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. 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
- NCT02026128
- Acronym / sponsor ID
- OHSU IRB#00008052
- Conditions
- Uveitis
- Keywords
- Uveitis, Inflammation, OCT, Grading
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jan 2014 (estimated)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Uveitis | – | –Physician-confirmed diagnosis of uveitis of any origin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (16 listed)
- 18 years of age and older
- With one or more of the following clinical features:
- In one of the following diagnostic categories as determined by a uveitis specialists:
Key exclusion criteria (2 listed)
- Inability to give informed consent;
- Inability to maintain stable fixation for OCT imaging.
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
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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. This study is not recruiting at the moment.
David Huang, MD, 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 Uveitis, 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 16 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denny Romfh, OD (503-494-4351, romfhd@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anterior chamber cells (time frame: 1 month). The study lists 4 primary outcomes in all. 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 12 Feb 2024.