N/A
N=21,283
Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Anterior Ischemic Optic Neuropathy · Ischemic Optic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT01260324 ↗Enrolled (actual)
21,283
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age — 0.01; 0.01; 0.03; 0.12 incidence rate per 1000 person-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention given in this observational study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age |
0.01; 0.01; 0.03; 0.12; 0.20; 0.35 | — |
| PRIMARY Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex |
0.04; 0.05 | — |
| PRIMARY Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year |
0.05; 0.04; 0.05; 0.04; 0.05 | — |
| PRIMARY Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region |
0.03; 0.05; 0.05; 0.04 | — |
| PRIMARY Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors |
0.23; 0.15; 0.07; 0.31; 0.52; 0.34 | — |
| PRIMARY Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses |
1.04; 0.34; 0.45; 1.66; 6.93; 0.53 | — |
| PRIMARY Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use |
0.05; 0.06; 0.06; 0.07; 0.09 | — |
| PRIMARY Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) |
35; 3; 1; 35 | — |
| PRIMARY Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) |
1.00; 0.56; 1.00; 1.22 | — |
| PRIMARY Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) |
1.00; 0.62; 1.00; 2.03 | — |
Summary
The objectives of this study were to: (1) evaluate the natural history of non-arteritic anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION; and (3) identify potential risk factors for NAION.
Eligibility Criteria
Inclusion Criteria
- Member of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007
- 18 years of age or older
- Had at least 183 days of continuous enrollment in the database
- No doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry
Exclusion Criteria
- Less than 18 years of age
- Less than 183 days of continuous enrollment in the database
- At least one doctor visit associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry
Data sourced from ClinicalTrials.gov (NCT01260324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.