UveitisNCT01897935
Flare Photometry in Uveitis Patients
An observational study of Uveitis, run by ChromoLogic, LLC at 1 site in United States.
Trial summary
This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM). Patients meeting the inclusion/exclusion criteria will receive a standard eye examination including a slit lamp examination to collect ocular flare data. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Apr 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with uveitis seen in the uveitis clinic at the UW Medicine Eye Institute would be eligible for participation in the uveitis arm of the study (n ≤ 50). Patients with other, non-inflammatory forms of eye disease will be eligible for the non-inflammatory arm of the study (n ≤ 50).
Who may be able to join
- Age greater than 18 years
- Ability to understand and willingness to sign a written informed consent document.
- To be eligible for the uveitis arm of the study subjects must have active anterior chamber uveitis in one or both eyes as determined by a physician
- To be eligible for the non-inflammatory arm of the study the study subjects must have no ocular inflammation in either eye as determined by a physician.
Who cannot join
- Inability to give informed consent
- Exclusion criteria for the non-inflammatory arm: Signs of uveitis
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Medicine Eye Institute
Seattle, Washington, 98195
About this study
This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM). Patients meeting the inclusion/exclusion criteria will receive a standard eye examination including a slit lamp examination to collect ocular flare data. In addition to the standard eye examination, subjects will receive flare measurements using the OFAM device.
- Conditions
- Uveitis
- Keywords
- Uveitis
- Medical subject headings
- Uveitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish OFAM algorithms for quantitation of ocular flare
OFAM algorithms for quantitation of ocular flare will be established by comparing the output of the OFAM device to the flare measurements obtained during the standard slit lamp examination.
Measured: 3 months
Secondary outcomes (1)
Determine the impact that various potential confounders such as age and sex have on OFAM Measurements
OFAM data for various sub-groups (age and sex) will be compared in order to evaluate the degree to which each sub-group acts as a confounder for OFAM measurements.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionApr 2014
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.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChromoLogic, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UW Medicine Eye Institute
- Responsible party
- Sponsor
- Investigators
- Deborah Lam, MD, Principal investigator, UW Medicine Eye InstituteRussell Van Gelder, MD, Principal investigator, UW Medicine Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897935
- Sponsor's protocol ID
- OFAM_PRO_120417
- Status last verified
- Apr 2014
- First submitted
- 8 Jul 2013
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flare Photometry in Uveitis Patients
- ClinicalTrials.gov ID
- NCT01897935
- Acronym / sponsor ID
- OFAM_PRO_120417
- Conditions
- Uveitis
- Keywords
- Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ChromoLogic, LLCIndustry (pharma, biotech, devices)
- Collaborators
- UW Medicine Eye Institute
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Jul 2013 (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.
This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM). Patients meeting the inclusion/exclusion criteria will receive a standard eye examination including a slit lamp examination to collect ocular flare data. In addition to the standard eye examination, subjects will receive flare measurements using the OFAM device.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with uveitis seen in the uveitis clinic at the UW Medicine Eye Institute would be eligible for participation in the uveitis arm of the study (n ≤ 50). Patients with other, non-inflammatory forms of eye disease will be eligible for the non-inflammatory arm of the study (n ≤ 50).
Key inclusion criteria (4 listed)
- Age greater than 18 years
- Ability to understand and willingness to sign a written informed consent document.
- To be eligible for the uveitis arm of the study subjects must have active anterior chamber uveitis in one or both eyes as determined by a physician
- To be eligible for the non-inflammatory arm of the study the study subjects must have no ocular inflammation in either eye as determined by a physician.
Key exclusion criteria (2 listed)
- Inability to give informed consent
- Exclusion criteria for the non-inflammatory arm: Signs of uveitis
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
Establish OFAM algorithms for quantitation of ocular flare
Time frame: 3 months
OFAM algorithms for quantitation of ocular flare will be established by comparing the output of the OFAM device to the flare measurements obtained during the standard slit lamp examination.
1 secondary outcome
Determine the impact that various potential confounders such as age and sex have on OFAM Measurements
Time frame: 3 months
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 1 May 2014.
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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.
Deborah Lam, MD principal investigator
UW Medicine Eye Institute
Russell Van Gelder, MD principal investigator
UW Medicine Eye Institute
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 ChromoLogic, LLC 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 4 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: finished, as of the sponsor's last update on 1 May 2014. 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?
Establish OFAM algorithms for quantitation of ocular flare (time frame: 3 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 1 May 2014.