CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 345 enrolled
Drug / intervention
PDE5 Inhibitorsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01131104
NCT01131104N/ACompleted
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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)

Eli Lilly and Company·observational·Posted May 26, 2010·Updated Apr 5, 2018

In Brief

An observational study evaluating PDE5 Inhibitors for Nonarteritic Anterior Ischemic Optic Neuropathy. Completed, enrolled 345 participants across 44 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNonarteritic Anterior Ischemic Optic Neuropathy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 26, 2010
Enrollment StartMay 1, 2010
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 16.1 years ago

Interventions

PDE5 Inhibitorsdrug

Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.