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OCT in Rare Chorioretinal Diseases

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ClinicalTrials.gov Identifier: NCT02141308
Recruitment Status : Recruiting
First Posted : May 19, 2014
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Brief Summary:

This study will evaluate the total blood flow in the retina and choroid (structures in the back of the eye) by Doppler optical coherence tomography (OCT) and OCT angiography. Angiography is mapping of the blood vessels.

The purpose of measuring blood flow in the retina and choroid is to 1.) determine if rare diseases in these structures causes a change in blood flow compared to healthy eyes and 2.) find out if areas of changed blood flow line up with areas of damage that appear on conventional testing.


Condition or disease
Retinal Artery Occlusions Polypoidal Choroidal Vasculopathy Retinal Arterial Macroaneurysm Juxtafoveal Telangiecasia Central Serous Chorioretinopathy

Detailed Description:

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 by measuring the intensity of reflected light. Tomographic images are generated by scanning the optical probe beam across the tissue structure of interest. OCT has become one of the most widely used imaging technologies by ophthalmologists. Its advantages include being a non-contact imaging modality, having micron-level resolution, producing a digital image that can be viewed electronically, and providing a reproducible quantitative measurement. New functional OCT including Doppler OCT and OCT angiography may allow an assessment of retinal blood flow and do away with the need for the more invasive fluorescein angiography (FA) test.

Thus, if the diagnostic data provided by functional OCT are at least equivalent or superior to those achieved by FA, patients and healthcare providers could realize a substantial benefit in utilizing this technology in the evaluation of retinal vascular disease. Even in the scenario in which an FA is not usually clinically indicated, OCT angiography may provide information over that of standard OCT and clinical examination and history, that might help clinicians better understand the etiology of the disease, and may even help inform treatment response.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Rare Retinal and Choroidal Diseases
Actual Study Start Date : May 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Rare Chorioretinal Disease
Up to 150 patients diagnosed with a rare retinal or choroidal disease will be considered and evaluated for enrollment in this study.



Primary Outcome Measures :
  1. Total Retinal and Choroidal Blood Flow [ Time Frame: One year ]
    Determination whether disease affecting the retina and/or choroid shows a change in blood flow that differs from healthy eyes.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals 18 years of age and older presenting to the Retina Service within the Department of Ophthalmology at the Casey Eye Institute of Oregon Health & Science University with signs and symptoms of rare choroidal or retinal diseases will be evaluated for enrollment into this study.
Criteria

Subject-Level Criteria:

Inclusion a. Diagnosis of retinal or choroidal disease

Exclusion

  1. Inability to give informed consent.
  2. Inability to complete study tests within a 30 day period
  3. Significant renal disease, defined as a history of chornic renal failure requiring dialysis or kidney transplant.
  4. 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).
  5. 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.
  6. 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.

Study-Eye Criteria:

Inclusion

a. Diagnosis of retinal or choroidal disease

Exclusion

  1. Inability to maintain stable fixation for OCT imaging.
  2. 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)
  3. 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).
  4. Media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner.

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): NCT02141308


Contacts
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Contact: Denny Romfh 503-494-4351 romfhd@ohsu.edu
Contact: David Poole 503-494-8024 pooleb@ohsu.edu

Locations
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United States, Oregon
Casey Eye Institute, Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Denny Romfh    503-494-4351    romfhd@ohsu.edu   
Contact: David Poole    503-494-8024    pooleb@ohsu.edu   
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: James Rosenbaum, MD         
Sub-Investigator: Eric Suhler, MD         
Sub-Investigator: David Huang, MD, PhD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Phoebe Lin, MD, PhD Oregon Health & Science Univeristy

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Responsible Party: David Huang, Assistant Professor of Ophthalmology, Retina & Vitreous Diseases, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02141308    
Other Study ID Numbers: IRB00010511
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Keywords provided by David Huang, Oregon Health and Science University:
Retina
Optical coherence tomography
Imaging
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Artery Occlusion
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases
Arterial Occlusive Diseases