NCT01897935

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

10 months

First QC Date

July 8, 2013

Last Update Submit

April 30, 2014

Conditions

Uveitis

Keywords

Uveitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Determine the impact that various potential confounders such as age and sex have on OFAM Measurements

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Medicine Eye Institute

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Deborah Lam, MD

    UW Medicine Eye Institute

    PRINCIPAL INVESTIGATOR

  • Russell Van Gelder, MD

    UW Medicine Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 12, 2013

Study Start

June 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

US(1)