NCT02026128

Brief Summary

Optical Coherence Tomography (OCT) machines are non-contact instruments that can provide micrometer (one one-thousandths) scale imaging of biological tissue. This allows excellent assessment of the white blood and inflammatory cells seen in uveitis, an inflammation of any or all parts of the uvea (iris, ciliary body, choroid).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

13.8 years

First QC Date

December 30, 2013

Last Update Submit

February 8, 2024

Conditions

Keywords

UveitisInflammationOCTGrading

Outcome Measures

Primary Outcomes (4)

  • Number of anterior chamber cells

    Anterior chamber cells will be identified from OCT images by computer algorithms. Anterior chamber cells will be measured in particles.

    1 month

  • Number of keratic precipitates (KP)

    KPs will be identified from OCT images by computer algorithms. KPs will be measured in particles.

    1 month

  • Number of vitreous cells

    Vitreous cells will be identified from OCT images by computer algorithms. Vitreous cells will be measured in particles.

    1 month

  • Degree of anterior chamber flare

    OCT signal of the aqueous humor will be analyzed and correlated with slit lamp grades on AC flare. AC flare will be measured in a.u.

    1 month

Study Arms (1)

Active Uveitis

Physician-confirmed diagnosis of uveitis of any origin.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will enroll both males and females and include all ethnic and racial groups through clinical practices. The study will enroll subjects 18 years of age or older with physician-confirmed, active uveitis. A total of thirty subjects will be recruited.

You may qualify if:

  • years of age and older
  • With one or more of the following clinical features:
  • \>1+ AC cells;
  • \>1+ vitreous haze;
  • presence of vitreous cells;
  • presence of blood in anterior chamber;
  • presence of blood in vitreous;
  • presence of aqueous or vitreous pigment.
  • In one of the following diagnostic categories as determined by a uveitis specialists:
  • uveitis due to ankylosing spondylitis (positive HLA B27 genotype);
  • uveitis due to sarcoidosis;
  • uveitis of any additional type;
  • uveitis masquerade such as pigment dispersion syndrome or Schaffer's sign;
  • hyphema due to trauma or other causes;
  • vitreous hemorrhage;
  • +1 more criteria

You may not qualify if:

  • Inability to give informed consent;
  • Inability to maintain stable fixation for OCT imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

UveitisInflammation

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Huang, MD, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denny Romfh, OD

CONTACT

Humberto Martinez, COT

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David Huang, MD, PhD, Professor of Ophthalmology & Director of Research, Casey Eye Institute OHSU

Study Record Dates

First Submitted

December 30, 2013

First Posted

January 1, 2014

Study Start

March 1, 2012

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations