Flare Photometry in Uveitis Patients

Uveitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897935
• Other study ID #: OFAM_PRO_120417
• Status: Completed
• Phase: N/A
• First received: July 8, 2013
• Last updated: April 30, 2014
• Start date: June 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: ChromoLogic, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical 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. In addition to the standard eye examination, subjects will receive flare measurements using the OFAM device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Uveitis

Locations

Country	Name	City	State
United States	UW Medicine Eye Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
ChromoLogic, LLC	UW Medicine Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No