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 |
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.
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
44
sites
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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