UveitisNCT03531853
OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
A study testing hand-held swept source optical coherence tomography in people with Uveitis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on OCT to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- What is being tested?
- hand-held swept source optical coherence tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 10 Mar 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pre-clinical: employees or students (over the age of 18) of the Duke Eye Center or Biomedical Engineering willing to be imaged with OCT system
- Pilot (ER): patients (over the age of 18) presenting emergently to the Duke Emergency room with traumatic eye injuries and/or suspected open globe
- Pilot (Uveitis): patients presenting to the Duke Eye Center with active uveitis and microhyphema or hyphema; patients who have independently consented to undergo vitreous tap or biopsy for their uveitis care at the Duke Eye Center
Who cannot join
- Pre-clinical: subject cannot be a direct report to any of the PIs or other key personnel of this study
- Pilot (ER): hemodynamically unstable, unable to consent
- Pilot (Uveitis): unable to consent; cornea or lens opacity/scar which would block the imaging modality
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
The purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on OCT to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye).
- Conditions
- Uveitis
- Being tested
- hand-held swept source optical coherence tomography
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand-held swept source optical coherence tomographyDevice
images the eye
| Study group | Role | What they receive |
|---|---|---|
| Imaging patients | Experimental | Get uveitis patients and ER patients to image their eyes Receives: Device: hand-held swept source optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance
By the ability to detect cells in the eye compared to clinical exam
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start14 Nov 2018
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
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 Duke 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Kuo, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531853
- Sponsor's protocol ID
- Pro00092968
- Status last verified
- Jun 2022
- First submitted
- 9 May 2018
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
- ClinicalTrials.gov ID
- NCT03531853
- Acronym / sponsor ID
- Pro00092968
- Conditions
- Uveitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 22 May 2018 (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 purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on OCT to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging patients | Experimental | Device: hand-held swept source optical coherence tomographyGet uveitis patients and ER patients to image their eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-clinical: employees or students (over the age of 18) of the Duke Eye Center or Biomedical Engineering willing to be imaged with OCT system
- Pilot (ER): patients (over the age of 18) presenting emergently to the Duke Emergency room with traumatic eye injuries and/or suspected open globe
- Pilot (Uveitis): patients presenting to the Duke Eye Center with active uveitis and microhyphema or hyphema; patients who have independently consented to undergo vitreous tap or biopsy for their uveitis care at the Duke Eye Center
Key exclusion criteria (3 listed)
- Pre-clinical: subject cannot be a direct report to any of the PIs or other key personnel of this study
- Pilot (ER): hemodynamically unstable, unable to consent
- Pilot (Uveitis): unable to consent; cornea or lens opacity/scar which would block the imaging modality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hand-held swept source optical coherence tomographyimages the eye | Device | Imaging patients |
Primary outcome
Concordance
Time frame: Up to 18 months
By the ability to detect cells in the eye compared to clinical exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Uveitis
Not yet recruitingObservational study
The Microbiome in Uveitis and Pediatric Inflammatory Diseases
Noninfectious Uveitis
RecruitingObservational study
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
Presumed Trematode Induced Uveitis, Uveitis
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A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
Active Non-anterior, Non-infectious Uveitis
Not yet recruitingPhase 2
A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
Noninfectious Intermediate, Posterior, or Panuveitis
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Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
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.
Anthony Kuo, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand-held swept source optical coherence tomography in people with Uveitis, run by Duke 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 3 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: finished, as of the sponsor's last update on 27 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance (time frame: Up to 18 months). 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 27 Jun 2022.