Clinical trial NCT01260324: Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Official title: The Detection and Epidemiology of NAION in a Commercially Insured Population in the United States.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Ischemic Optic Neuropathy
Ischemic Optic Neuropathy
Keywords: Phosphodiesterase type 5 inhibitors
non-arteritic anterior ischemic optic neuropathy
descriptive epidemiology study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 21283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of members of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007, who were 18 years of age or older with at least 183 days of continuous enrollment in the database and without any doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry.

Brief 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.

Detailed description: The study population consisted of members of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007, who were 18 years of age or older with at least 183 days of continuous enrollment in the database and without any doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry.

From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283).

From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)

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

Primary outcomes:
measure: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
timeFrame: 01-January-2003 up to 31-December-2007
measure: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex
timeFrame: 01-January-2003 up to 31-December-2007
measure: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
timeFrame: 01-January-2003 up to 31-December-2007
measure: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region
timeFrame: 01-January-2003 up to 31-December-2007
measure: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
timeFrame: 01-January-2003 up to 31-December-2007
measure: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
timeFrame: 01-January-2003 up to 31-December-2007
measure: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
timeFrame: 01-January-2003 up to 31-December-2007
measure: Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)
timeFrame: 01-January-2003 up to 31-December-2007
measure: Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
timeFrame: 01-January-2003 up to 31-December-2007
measure: Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
timeFrame: 01-January-2003 up to 31-December-2007
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: