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OCT in Retinal Vein Occlusions

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.
 
ClinicalTrials.gov Identifier: NCT01992575
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Brief Summary:

Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of these conditions, retinal vein occlusions are the most common. Vision loss can occur as a result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid build-up at the macula).

OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structures 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 changes due to retinal vein occlusions 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. These studies will be evaluated to see how they relate to vision loss.


Condition or disease
Retinal Vein Occlusions

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Retinal Vein Occlusions
Study Start Date : January 2014
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort
Retinal Vein Occlusion Group
Up to 35 patients diagnosed with retinal vein occlusions will be considered and evaluated for enrollment in this study.



Primary Outcome Measures :
  1. Blood flow patterns and ischemia in retinal vein occlusions [ Time Frame: 24 months ]
    To determine if identifying early changes in blood vessel patterns and ischemia will aid in early diagnosis and treatment of retinal vein occlusions



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 vein occlusions.
Criteria

Inclusion Criteria:

  • Diagnosis of branch or central retinal vein occlusion

Exclusion Criteria:

  • Inability to give informed consent
  • Inability to complete 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-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 PRP or focal laser that would alter the macular perfusion and retino-vascular features.
  • Inability to maintain 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 (e.g., 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 surgeries (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within 4 months prior to enrollment.

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 ClinicalTrials.gov identifier (NCT number): NCT01992575


Locations
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United States, Oregon
OHSU
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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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
ClinicalTrials.gov Identifier: NCT01992575    
Other Study ID Numbers: OHSU IRB#00010138
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Keywords provided by David Huang, Oregon Health and Science University:
Retinal vein occlusion
OCT
Optical coherence tomography
Imaging
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases