Flare Photometry in Uveitis Patients

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 Overview

• Status: Completed
• Conditions: Uveitis

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • UW Medicine Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Inability to give informed consent
• Exclusion criteria for the uveitis arm: no active disease
• Exclusion criteria for the non-inflammatory arm: Signs of uveitis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: ChromoLogic, LLC
• Collaborators: UW Medicine Eye Institute
• Investigators: Principal Investigator: Deborah Lam, MD, UW Medicine Eye Institute; Principal Investigator: Russell Van Gelder, MD, UW Medicine Eye Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: April 30, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Uveitis
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: OFAM_PRO_120417