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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Detection and Epidemiology of NAION in a Commercially Insured Population in the United States.

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 Summary:

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)


Sponsor: Pfizer

Current Primary Outcome:

  • 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 ]
    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 ]
    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 ]
    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 ]
    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-arter

    Original Primary Outcome:

    • Incidence of non-arteritic anterior ischemic optic neuropathy (NAION) [ Time Frame: 01/01/2003 - 12/31/2007 ]
    • Frequency of phosphodiesterase type 5 (PDE-5) inhibitor use [ Time Frame: 01/01/2003 - 12/31/2007 ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    • Frequency of clinical characteristics [ Time Frame: 01/01/2003 - 12/31/2007 ]

      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 ]
      Demographic characteristics include age, gender, calendar year of NAION diagnosis, and geographic region.


    Information By: Pfizer

    Dates:
    Date Received: November 5, 2010
    Date Started: August 2008
    Date Completion:
    Last Updated: August 17, 2011
    Last Verified: August 2011