A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
- Conditions
- Nonarteritic Anterior Ischemic Optic Neuropathy
- Interventions
- Drug: PDE5 Inhibitors
- Registration Number
- NCT01131104
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 345
- Adult male subjects, at least 18 years of age, who are willing to participate in the study
- 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
- Previous history of NAION
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 PDE5 Inhibitors Participants with NAION who have used PDE5 inhibitors
- Primary Outcome Measures
Name Time Method 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use 30 days prior to NAION onset Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Neuro-Ophthalmic Services
🇺🇸Royal Oak, Michigan, United States
Precision Eye Care
🇺🇸National City, California, United States
Henry Ford Health System
🇺🇸Dearborn, Michigan, United States
JFK Medical Center, NJ Neuroscience Institute
🇺🇸Edison, New Jersey, United States
Atlantic Clinical Trials, LLC
🇺🇸Watertown, Massachusetts, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Stony Brook University Medical Center
🇺🇸East Setauket, New York, United States
Ohio State Univ College Of Medicine
🇺🇸Columbus, Ohio, United States
Neuro-Opthalmology of Texas
🇺🇸Houston, Texas, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
University of Minnesota Medical School
🇺🇸Minneapolis, Minnesota, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Cockerham Eye Consultant
🇺🇸Los Altos, California, United States
USF Eye Institute
🇺🇸Tampa, Florida, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Russell P Edwards M.D.
🇺🇸San Diego, California, United States
Eye Surgical & Medical Associates, Inc.
🇺🇸Visalia, California, United States
Pacific Eye Associates
🇺🇸San Francisco, California, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
University of Illinois At Chicago Med Center
🇺🇸Chicago, Illinois, United States
Northshore Eye and Vision Center
🇺🇸Glenview, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
Univ KY Clinical Resch Org- KY Clinic
🇺🇸Lexington, Kentucky, United States
Bethesda Neurology, LLC
🇺🇸Bethesda, Maryland, United States
Longwood Medical Eye Center
🇺🇸Boston, Massachusetts, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
E.S. Harkness Eye Institute
🇺🇸New York, New York, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
Allegheny Ophthalmic & Orbital Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Dr. Daniel Lin
🇺🇸Oregon, Ohio, United States
Family Eye Care
🇺🇸Lancaster, Pennsylvania, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Swedish Neuroscience Institute
🇺🇸Seattle, Washington, United States
University of Florida - Gainesville
🇺🇸Gainesville, Florida, United States
North Bay Eye Associates, Inc.
🇺🇸Petaluma, California, United States
Avail Clinical Research LLC
🇺🇸DeLand, Florida, United States
The Eye Care Group
🇺🇸New Haven, Connecticut, United States
Retina Consultants of Charleston
🇺🇸Charleston, South Carolina, United States
Montefiore Medical Center
🇺🇸The Bronx, New York, United States