ClinicalTrials.gg
Sign In
Active, not recruitingNCT04704609IQIUpdated Mar 4, 2026

Imaging Quantification of Inflammation (IQI)

An observational study in Uveitis, sponsored by The Cleveland Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
01

Study summary

1. Perform observational study utilizing real-time quantification of ocular inflammation to determine minimal important change.

Prospective use of changes in imaging quantification of inflammation (IQI) scores in determining treatment decisions both utilizing novel FA viewer software.

Read the detailed description

  1. Perform observational study utilizing real-time quantification of ocular inflammation to determine minimal important change.

    In our current experiments, we have calculated reliability measurements including the standard error of measurement (SEM) for our software tools. Our hypothesis is that the minimal important change seen clinically will be at least equal to the standard error of measurement. This is based on previous work observing the use of SEM as the minimal important change on outcome scales.56-58 We hypothesize that changes in the imaging quantification of inflammation scores (IQI) of greater than SEM, will lead to observed changes in visual function.

    To test our hypothesis we will prospectively observe 25 patients with uveitis who are either active or were recently active in the previous 6 months. All of the patients will have standard clinical exams at baseline and image quantification of their inflammation using OCT, OCTA and UWFFA (if needed). At baseline, ETDRS vision, contrast sensitivity, hand held electroretinography and a visual function questionnaire (NEI-VFQ 25) will be administered. Patients will be followed for 6 months. During follow-up repeat imaging quantification of inflammation will be performed along with standard examinations, visual acuity and contrast sensitivity measurements and hand held ERG. At the final visit, all tests will be repeated. Data collected will be analyzed using statistical software package. Correlations between changes in imaging quantification of inflammation scores and changes in visual acuity, clinical grades of inflammation, visual function scores and contract sensitivity will be calculated. Expected outcomes include confirmation that a change in IQI scores greater than standard error of measurement will result in a clinically meaningful change. We now would have a definition of improvement and worsening based on changes in IQI scores.

    Image acquisition protocols will depend on subtype of uveitis. In those with anterior uveitis, only OCT, OCTA and anterior segment OCT will be obtained by study staff. In those with posterior segment uveitis, UWFFA will be obtained as part of standard of care.

  2. Prospective use of changes in imaging quantification of inflammation (IQI) scores in determining treatment decisions As the above experiment will have defined the scores required for improvement and worsening, we will assess the use of these tools in making clinical treatment decisions. We hypothesize that clinician use of imaging based quantification of inflammation (IQI) scores will impact clinical decision making. We intend to test our hypothesis with the following experiment. 25 patients with active or recently active (within 6 months) uveitis will be enrolled in a prospective study. At baseline patients will have standard of care examinations performed and IQI scores will be acquired using OCT, OCTA and UWFFA. Patients will be followed over a period of 1 year. At subsequent follow-up visits, IQI scores will be obtained. Prior to the clinician examining the patient, the IQI scores will be reviewed and compared to the previous visit(s). The clinician will then fill out a survey form indicating if (s)he would treat based on IQI scores, observe based on IQI scores, or can't decide by IQI alone. At this point the clinician would then examine the patient and fill out a second questionnaire evaluating whether (a) clinical exam agreed with IQI, (b) clinical exam did not agree with IQI (c) clinical exam did not pick up changes that IQI found. The patient will then be treated by clinical judgment with clinical exam and IQI scores available to the physician. The data collected will be analyzed using a statistical software package. (SAS) Percentage agreement, correlation between exam results and IQI scores will be assessed.
02

Conditions studied

  • Uveitis

Browse trials for

03

In context

Uveitis

299 studies on the registry are indexed under Uveitis; 32 are open to participants now.

This study's enrollment of 50 is below the median of 107 across 104 observational studies indexed under Uveitis.

Browse Uveitis studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Browse The Cleveland Clinic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with ocular inflammation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist

Exclusion criteria

Exclusion Criteria:

  • Poor view in fundus in both eyes which precludes image acquisition in those with posterior uveitis
  • Those with posterior uveitis, any allergy to fluorescein
  • Corneal opacities which prevent image acquisition
  • Inability to sign consent
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Imaging Analysis of patients with uveitis

    Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist

    Other: Standard of Care Imaging

Interventions

  • OtherStandard of Care Imaging

    We are collecting imaging that is standard of care for uveitis patients

06

What researchers measure

Primary outcomes

  1. Real Time Quantification of Ocular inflammation

    Perform observational study utilizing real-time quantification of ocular inflammation to determine minimal important change using FA viewer software.

    Time frame: 6 months

Secondary outcomes

  1. Scoring ocular inflammation for clinical use

    Prospective use of changes in imaging quantification of inflammation (IQI) scores in determining treatment decisions

    Time frame: 6 months

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2019 (actual). Primary completion is estimated for Apr 2027, 90 months after the start.

Of 32 observational studies under Uveitis, half reached primary completion within 77 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 143. This study's planned 90 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2020
First posted
Jan 11, 2021
StartActual
Sep 22, 2019
Primary completionEst.
Apr 20, 2027
CompletionEst.
Sep 30, 2027
Last update
Mar 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04704609
Lead sponsor
The Cleveland Clinic
Collaborators
Santen Inc.
Responsible party
Sunil Srivastava (Principle Investigator, The Cleveland Clinic) — Principal investigator
First posted
Jan 11, 2021
Start date
Sep 22, 2019
Primary completion
Apr 20, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Mar 4, 2026

Study contacts

Sunil K Srivastava, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Uveitis →

Other studies from this sponsor

The Cleveland Clinic →

Start the discussion