Optical Coherence Tomography (OCT) in Retinal Vasculitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01998464
First received: November 18, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the retina, the tissue that lines the inside of the eye. This inflammation may occur on its own or as a result of an infectious, cancerous, or inflammatory disorder.

Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves.

The purpose of this study is to see if non-invasive OCT technology can diagnose retinal vasculitis as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. The study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT.


Condition
Retinal Vasculitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Retinal Vasculitis

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Blood flow patterns in retinal vasculitis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To determine if identifying early changes in blood vessel patterns will aid in early diagnosis and treatment of retinal vasculitis.


Secondary Outcome Measures:
  • Ischemia in retinal vasculitis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To determine if identifying lost or reduced blood flow will aid in early diagnosis and treatment of retinal vasculitis


Estimated Enrollment: 35
Study Start Date: January 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Retinal Vasculitis Group
Up to 35 patients diagnosed with retinal vasculitis will be considered and evaluated for enrollment in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study will measure blood vessel pattern/flow changes in up to 35 patients with retinal vasculitis.

Criteria

Inclusion Criteria:

  • Diagnosis of retinal vasculitis

Exclusion Criteria:

  • Inability to give informed consent.
  • Inability to complete the qualifying study tests within a 30 day period from date of enrollment
  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • A prior history of reaction to fluorescein or other dyes.
  • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
  • Systemic anti-vascular endothelial growth factor (VEGF) or pro-VEGF treatment within 4 months prior to treatment.
  • Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography.
  • Prior panretinal photocoagulation (PRP) or focal laser that would alter the macular perfusion and retinovascular features.
  • Inability to maintain stable fixation for OCT imaging.
  • Other ocular condition is present such that, in the opinion of the investigator, may alter the retinal perfusion.
  • An ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (i.e. cataract)
  • Substantial cataract that, in the opinion of the investigator, is likely to decrease visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 20/40 or worse if the eye was otherwise normal).
  • Media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner.
  • History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc) within prior 4 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998464

Contacts
Contact: Denny Romfh 503-494-4351 romfhd@ohsu.edu
Contact: Janice Ladwig 503-494-8024 ladwig@ohsu.edu

Locations
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Denny Romfh    503-494-4351    romfhd@ohsu.edu   
Contact: Janice Ladwig    503-494-8024    ladwig@ohsu.edu   
Sub-Investigator: Neal Palejwala, MD         
Sub-Investigator: Justin Baynham, MD         
Sub-Investigator: John Campbell, MD, MPH         
Sub-Investigator: Andreas Lauer, MD         
Sub-Investigator: Christina Flaxel, MD         
Sub-Investigator: Thomas Hwang, MD         
Sub-Investigator: Michael Klein, MD         
Sub-Investigator: Steven Bailey, MD         
Sub-Investigator: David Huang, MD, PhD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Phoebe Lin, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: David Huang, Phoebe Lin, MD, PhD, Assistant Professor of Ophthalmology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01998464     History of Changes
Other Study ID Numbers: OHSU IRB#00010137
Study First Received: November 18, 2013
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Retinal Vasculitis
Optical coherence tomography
OCT
Imaging

Additional relevant MeSH terms:
Vasculitis
Retinal Vasculitis
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014