UveitisIQINCT04704609
Imaging Quantification of Inflammation (IQI)
An observational study of Uveitis, run by The Cleveland Clinic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uveitis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2019to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ocular inflammation.
Who may be able to join
- Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Foundation Cole Eye Institute
Cleveland, Ohio, 44195
About this study
- 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
- 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.
- 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.
- Conditions
- Uveitis
- Being tested
- Standard of Care Imaging
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care ImagingOther
We are collecting imaging that is standard of care for uveitis patients
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Standard of Care Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start22 Sep 2019
- Primary completion20 Apr 2027 (estimated)
- Study completion30 Sep 2027 (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 The Cleveland ClinicThe 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Inc.
- Responsible party
- Principal investigator, Sunil Srivastava, The Cleveland Clinic
- Investigators
- Sunil K Srivastava, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704609
- Sponsor's protocol ID
- 17-1258
- Acronym
- IQI
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Quantification of Inflammation (IQI)
- ClinicalTrials.gov ID
- NCT04704609
- Acronym / sponsor ID
- IQI / 17-1258
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Santen Inc.
- Study start
- 22 Sep 2019 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Jan 2021 (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.
- 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.
Detailed description
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging Analysis of patients with uveitis | – | Other: Standard of Care ImagingAny patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ocular inflammation.
Key inclusion criteria (1 listed)
- Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Standard of Care ImagingWe are collecting imaging that is standard of care for uveitis patients | Other | Imaging Analysis of patients with uveitis |
Primary outcome
Real Time Quantification of Ocular inflammation
Time frame: 6 months
Perform observational study utilizing real-time quantification of ocular inflammation to determine minimal important change using FA viewer software.
1 secondary outcome
Scoring ocular inflammation for clinical use
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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.
Sunil K Srivastava, MD principal investigator
The Cleveland Clinic
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 The Cleveland Clinic 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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Real Time Quantification of Ocular inflammation (time frame: 6 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 4 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.