UveitisNCT02907814
Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography
A study testing Optical Coherence Tomography (OCT) and Eye Exam in people with Uveitis, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Optical Coherence Tomography (OCT) is routinely used in ophthalmic clinical practice. It uses infrared light to image patient's eyes. Some patients, such as those with an inflammatory disease called uveitis or those who have just undergone cataract surgery, have intraocular inflammation. 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?
- Optical Coherence Tomography (OCT) and Eye Exam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age over 18 years old
- Intervention Arm:
- Active anterior chamber inflammation in at least one eye as diagnosed by clinical exam
- One of the following: 1) diagnosis of uveitis OR 2) undergone cataract extraction surgery within the previous 30 days
- Control Arm:
- No active intraocular inflammation based on clinical exam
Who cannot join
- Corneal opacities in the affected eye
- Anyone judged unable to understand or consent to study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective, Prospective Measurement of Anterior Chamber Cell Grading Using Anterior Chamber Ocular Coherence Tomography
Optical Coherence Tomography (OCT) is routinely used in ophthalmic clinical practice. It uses infrared light to image patient's eyes. Some patients, such as those with an inflammatory disease called uveitis or those who have just undergone cataract surgery, have intraocular inflammation. This intraocular inflammation commonly manifests as cells that can be seen on routine microscopic clinical examination. However, the only currently available method to quantify this intraocular inflammation is by manually counting on the microscopic clinical examination. The investigators plan to use the OCT machine to image patient's eyes. The investigators will then use the images obtained from the OCT to objectively quantify the degree of intraocular inflammation.
- Conditions
- Uveitis
- Being tested
- Optical Coherence Tomography (OCT), Eye Exam
- Keywords
- Uveitis, 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.
Optical Coherence Tomography (OCT)Device
The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed.
Eye ExamOther
This is a brief, non-contact ocular exam.
| Study group | Role | What they receive |
|---|---|---|
| Uveitis and Cataract Imaging Group | Experimental | Subjects will undergo up to three optical coherence tomography scans. Receives: Device: Optical Coherence Tomography (OCT) |
| Control | Experimental | Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. Receives: Device: Optical Coherence Tomography (OCT); Other: Eye Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Identified Inflammatory Cells on OCT Scan
This measure pertains to the identification of cells in OCT scan of the participants. The inflammatory cells to be identified refer to white blood cells. The anterior segment OCT scan was used to attempt to identify these cells in the anterior chamber of the eyes of the participants.
Measured: Through study completion, up to 1 year.
Secondary outcomes (1)
Change in Cell Density Identified by OCT Scans Over Time
Identification of changes in cell density in OCT scans over time
Measured: Baseline and up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Lack of administrative support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David S. Chu, MD, Rutgers, The State University of New Jersey
- Investigators
- David S Chu, MD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907814
- Sponsor's protocol ID
- Pro20160000585
- Status last verified
- May 2019
- First submitted
- 7 Sep 2016
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kempen JH, Ganesh SK, Sangwan VS, Rathinam SR. Interobserver agreement in grading activity and site of inflammation in eyes of patients with uveitis. Am J Ophthalmol. 2008 Dec;146(6):813-8.e1. doi: 10.1016/j.ajo.2008.06.004. Epub 2008 Aug 8.
PubMed 18687418Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
PubMed 16196117User Manual: SPECTRALIS HRA+OCT. Heidelberg Engineering GmbH;2012.
Agarwal A, Ashokkumar D, Jacob S, Agarwal A, Saravanan Y. High-speed optical coherence tomography for imaging anterior chamber inflammatory reaction in uveitis: clinical correlation and grading. Am J Ophthalmol. 2009 Mar;147(3):413-416.e3. doi: 10.1016/j.ajo.2008.09.024. Epub 2008 Dec 3.
PubMed 19054493Li Y, Lowder C, Zhang X, Huang D. Anterior chamber cell grading by optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Jan 9;54(1):258-65. doi: 10.1167/iovs.12-10477.
PubMed 23249705Igbre AO, Rico MC, Garg SJ. High-speed optical coherence tomography as a reliable adjuvant tool to grade ocular anterior chamber inflammation. Retina. 2014 Mar;34(3):504-8. doi: 10.1097/IAE.0b013e31829f73bd.
PubMed 23945636Sharma S, Lowder CY, Vasanji A, Baynes K, Kaiser PK, Srivastava SK. Automated Analysis of Anterior Chamber Inflammation by Spectral-Domain Optical Coherence Tomography. Ophthalmology. 2015 Jul;122(7):1464-70. doi: 10.1016/j.ophtha.2015.02.032. Epub 2015 Apr 4.
PubMed 25846846
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective, Prospective Measurement of Anterior Chamber Cell Grading Using Anterior Chamber Ocular Coherence Tomography
- ClinicalTrials.gov ID
- NCT02907814
- Acronym / sponsor ID
- Pro20160000585
- Conditions
- Uveitis
- Keywords
- Uveitis, Optical Coherence Tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of administrative support
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 6 May 2019
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) is routinely used in ophthalmic clinical practice. It uses infrared light to image patient's eyes. Some patients, such as those with an inflammatory disease called uveitis or those who have just undergone cataract surgery, have intraocular inflammation. This intraocular inflammation commonly manifests as cells that can be seen on routine microscopic clinical examination. However, the only currently available method to quantify this intraocular inflammation is by manually counting on the microscopic clinical examination. The investigators plan to use the OCT machine to image patient's eyes. The investigators will then use the images obtained from the OCT to objectively quantify the degree of intraocular inflammation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uveitis and Cataract Imaging Group | Experimental | Device: Optical Coherence Tomography (OCT)Subjects will undergo up to three optical coherence tomography scans. |
| Control | Experimental | Device: Optical Coherence Tomography (OCT), Other: Eye ExamControl subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years old
- Intervention Arm:
- Control Arm:
Key exclusion criteria (2 listed)
- Corneal opacities in the affected eye
- Anyone judged unable to understand or consent to study participation
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 |
|---|---|---|
| Optical Coherence Tomography (OCT)The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. | Device | Control, Uveitis and Cataract Imaging Group |
| Eye ExamThis is a brief, non-contact ocular exam. | Other | Control |
Primary outcome
Number of Participants With Identified Inflammatory Cells on OCT Scan
Time frame: Through study completion, up to 1 year.
This measure pertains to the identification of cells in OCT scan of the participants. The inflammatory cells to be identified refer to white blood cells. The anterior segment OCT scan was used to attempt to identify these cells in the anterior chamber of the eyes of the participants.
1 secondary outcome
Change in Cell Density Identified by OCT Scans Over Time
Time frame: Baseline and up to 8 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18687418Kempen JH, Ganesh SK, Sangwan VS, Rathinam SR. Interobserver agreement in grading activity and site of inflammation in eyes of patients with uveitis. Am J Ophthalmol. 2008 Dec;146(6):813-8.e1. doi: 10.1016/j.ajo.2008.06.004. Epub 2008 Aug 8.
- Background: PubMed 16196117Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
- BackgroundUser Manual: SPECTRALIS HRA+OCT. Heidelberg Engineering GmbH;2012.
- Background: PubMed 19054493Agarwal A, Ashokkumar D, Jacob S, Agarwal A, Saravanan Y. High-speed optical coherence tomography for imaging anterior chamber inflammatory reaction in uveitis: clinical correlation and grading. Am J Ophthalmol. 2009 Mar;147(3):413-416.e3. doi: 10.1016/j.ajo.2008.09.024. Epub 2008 Dec 3.
- Background: PubMed 23249705Li Y, Lowder C, Zhang X, Huang D. Anterior chamber cell grading by optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Jan 9;54(1):258-65. doi: 10.1167/iovs.12-10477.
- Background: PubMed 23945636Igbre AO, Rico MC, Garg SJ. High-speed optical coherence tomography as a reliable adjuvant tool to grade ocular anterior chamber inflammation. Retina. 2014 Mar;34(3):504-8. doi: 10.1097/IAE.0b013e31829f73bd.
- Background: PubMed 25846846Sharma S, Lowder CY, Vasanji A, Baynes K, Kaiser PK, Srivastava SK. Automated Analysis of Anterior Chamber Inflammation by Spectral-Domain Optical Coherence Tomography. Ophthalmology. 2015 Jul;122(7):1464-70. doi: 10.1016/j.ophtha.2015.02.032. Epub 2015 Apr 4.
- Individual participant dataSharing planned: No
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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 S Chu, MD principal investigator
Rutgers 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 Optical Coherence Tomography (OCT) and Eye Exam in people with Uveitis, run by Rutgers, The State University of New Jersey 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 6 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: stopped early, as of the sponsor's last update on 6 May 2019. 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?
Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Identified Inflammatory Cells on OCT Scan (time frame: Through study completion, up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02907814, which also lists 7 linked publications.
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 6 May 2019.