Imaging Quantification of Inflammation (IQI) (IQI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Uveitis
• Intervention / Treatment: Other: Standard of Care Imaging

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation Cole Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ocular inflammation.

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; We are collecting imaging that is standard of care for uveitis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scoring ocular inflammation for clinical use	Prospective use of changes in imaging quantification of inflammation (IQI) scores in determining treatment decisions	6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Santen Inc.
• Investigators: Principal Investigator: Sunil K Srivastava, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2019
• Primary Completion (Estimated): April 20, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Inflammation; Uveitis
• Other Study ID Numbers: 17-1258

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No