View Clinical Trial (Medical Research Study)
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)
| City: |
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Visalia |
| State: |
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California |
| Zip Code: |
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93277 |
| Conditions: |
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Nonarteritic Anterior Ischemic Optic Neuropathy |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Adult male subjects, at least 18 years of age, who are willing to participate in the
study
- Patients 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
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| NCT ID: |
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NCT01131104 |
| Primary Contact: |
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Study Director
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)
Eli Lilly and Company
There may be multiple sites in this observational study 1-877-CTLILLY (1-877-285-4559)
Phone: 317-615-4559
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| Backup Contact: |
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N/A |
| Location Contact: |
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Visalia, California 93277
United States
Eli Lilly
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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