A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors



Status:Completed
Conditions:Peripheral Vascular Disease, Neurology, Neurology, Neurology, Neurology, Neurology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:May 2010
End Date:December 2015

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A Prospective Case-crossover Study to Evaluate the Possible Association Between the Use of PDE5 Inhibitors and the Risk of Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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Indianapolis, Indiana 46290
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Gainesville, Florida 32611
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Bethesda, Maryland 20814
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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