Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01260324
First received: November 5, 2010
Last updated: August 17, 2011
Last verified: August 2011

November 5, 2010
August 17, 2011
August 2008
March 2010   (final data collection date for primary outcome measure)
  • Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.
  • Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.
  • Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.
  • Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.
  • Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.
  • Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).
  • Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.
  • Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
  • Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
  • Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [ Time Frame: 01-January-2003 up to 31-December-2007 ] [ Designated as safety issue: Yes ]
    Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
  • Incidence of non-arteritic anterior ischemic optic neuropathy (NAION) [ Time Frame: 01/01/2003 - 12/31/2007 ] [ Designated as safety issue: Yes ]
  • Frequency of phosphodiesterase type 5 (PDE-5) inhibitor use [ Time Frame: 01/01/2003 - 12/31/2007 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01260324 on ClinicalTrials.gov Archive Site
Not Provided
  • Frequency of clinical characteristics [ Time Frame: 01/01/2003 - 12/31/2007 ] [ Designated as safety issue: No ]

    Clinical characteristics reviewed include the following:

    Potential NAION risk factors such as Diabetes, Erectile dysfunction, Hyperlipidemia, Myocardial infarction, Other coronary artery disease, Congestive heart failure, Hypertension, Smoking status, Prescription of nitrates, beta blockers, calcium channel blockers, diuretics, ACE inhibitors, anti-platelet agents.

  • Frequency of Demographic Characteristics [ Time Frame: 01/01/2003 - 12/31/2007 ] [ Designated as safety issue: No ]
    Demographic characteristics include age, gender, calendar year of NAION diagnosis, and geographic region.
Not Provided
Not Provided
 
Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
The Detection and Epidemiology of NAION in a Commercially Insured Population in the United States.

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.

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)

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Anterior Ischemic Optic Neuropathy
  • Ischemic Optic Neuropathy
Other: No intervention given in this observational study
No intervention given in this observational study
  • NAION cases
    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). Data from definite and possible NAION cases contributed to the analysis.
    Intervention: Other: No intervention given in this observational study
  • Controls
    From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
    Intervention: Other: No intervention given in this observational study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21283
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01260324
A1481282
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP