A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
NCT ID: NCT01131104
Last Updated: 2018-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
345 participants
OBSERVATIONAL
2010-05-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Cohort 1
Participants with NAION who have used PDE5 inhibitors
PDE5 Inhibitors
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
Interventions
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PDE5 Inhibitors
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of NAION symptoms to an ophthalmologist that resulted in a diagnosis of Suspected NAION by the investigator
Exclusion Criteria
* Previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis
* History of glaucoma in either one or both eyes
* History of multiple sclerosis or diagnostic testing evidence of optic neuritis
* Have dementia or other reasons for memory impairment in the opinion of the investigator
* Have participated in other non-observational studies within 3 months of NAION onset
18 Years
MALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fr- 9 AM-5 PM Eastern time (UTC?GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Cockerham Eye Consultant
Los Altos, California, United States
Precision Eye Care
National City, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Russell P Edwards M.D.
San Diego, California, United States
Pacific Eye Associates
San Francisco, California, United States
Eye Surgical & Medical Associates, Inc.
Visalia, California, United States
The Eye Care Group
New Haven, Connecticut, United States
Avail Clinical Research LLC
DeLand, Florida, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
USF Eye Institute
Tampa, Florida, United States
University of Illinois At Chicago Med Center
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Northshore Eye and Vision Center
Glenview, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Univ KY Clinical Resch Org- KY Clinic
Lexington, Kentucky, United States
Paducah Retinal Center
Paducah, Kentucky, United States
Bethesda Neurology, LLC
Bethesda, Maryland, United States
Longwood Medical Eye Center
Boston, Massachusetts, United States
Atlantic Clinical Trials, LLC
Watertown, Massachusetts, United States
Henry Ford Health System
Dearborn, Michigan, United States
Neuro-Ophthalmic Services
Royal Oak, Michigan, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
JFK Medical Center, NJ Neuroscience Institute
Edison, New Jersey, United States
Stony Brook University Medical Center
East Setauket, New York, United States
E.S. Harkness Eye Institute
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Ohio State Univ College Of Medicine
Columbus, Ohio, United States
Dr. Daniel Lin
Oregon, Ohio, United States
Family Eye Care
Lancaster, Pennsylvania, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Allegheny Ophthalmic & Orbital Associates
Pittsburgh, Pennsylvania, United States
Retina Consultants of Charleston
Charleston, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Neuro-Opthalmology of Texas
Houston, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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H6D-MC-LVHQ
Identifier Type: OTHER
Identifier Source: secondary_id
11638
Identifier Type: -
Identifier Source: org_study_id
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