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Optical Coherence Tomography (OCT) in Retinal Vasculitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01998464
Recruitment Status : Active, not recruiting
First Posted : November 29, 2013
Last Update Posted : April 9, 2020
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Brief Summary:

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 or disease
Retinal Vasculitis

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Retinal Vasculitis
Study Start Date : January 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis

Retinal Vasculitis Group
Up to 35 patients diagnosed with retinal vasculitis will be considered and evaluated for enrollment in this study.

Primary Outcome Measures :
  1. Blood flow patterns in retinal vasculitis [ Time Frame: 24 months ]
    To determine if identifying early changes in blood vessel patterns will aid in early diagnosis and treatment of retinal vasculitis. Total retinal blood flow will be measured in uL/min.

Secondary Outcome Measures :
  1. Ischemia in retinal vasculitis [ Time Frame: 24 months ]
    To determine if identifying lost or reduced blood flow will aid in early diagnosis and treatment of retinal vasculitis. Non-perfusion area will be measured in mm2.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01998464

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United States, Oregon
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: Phoebe Lin, MD, PhD Oregon Health and Science University
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Responsible Party: David Huang, Phoebe Lin, MD, PhD, Assistant Professor of Ophthalmology, Oregon Health and Science University Identifier: NCT01998464    
Other Study ID Numbers: OHSU IRB#00010137
First Posted: November 29, 2013    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Keywords provided by David Huang, Oregon Health and Science University:
Retinal Vasculitis
Optical coherence tomography
Additional relevant MeSH terms:
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Retinal Vasculitis
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases