A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

Viatris

Status: Completed

Conditions: Optic Neuropathy, Ischemic

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00759174

A1481259

Details and patient eligibility

About

The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.

Full description

Sites will identify patients who meet the entry criteria during the conduct of their normal practice. Patients meeting these criteria will be offered participation in the study after reading and completing an informed consent document.

Enrollment: 673 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male aged ≥45 years;
• Experienced abrupt visual change in only 1 eye

Exclusion criteria

• Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
• History of NAION or optic neuritis.
• Participation in other studies within 60 days prior to entry in the study.

Trial design

673 participants in 1 patient group

Case Group

Treatment:

Drug: No intervention