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

Ischemic Optic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260324
• Other study ID #: A1481282
• Status: Completed
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21283
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Ischemic Optic Neuropathy
• Ischemia
• Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic
• Peripheral Nervous System Diseases

Intervention

Other:
• No intervention given in this observational study
No intervention given in this observational study
• No intervention given in this observational study
No intervention given in this observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age	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.	01-January-2003 up to 31-December-2007
Primary	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex	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.	01-January-2003 up to 31-December-2007
Primary	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year	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.	01-January-2003 up to 31-December-2007
Primary	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region	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.	01-January-2003 up to 31-December-2007
Primary	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors	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.	01-January-2003 up to 31-December-2007
Primary	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses	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).	01-January-2003 up to 31-December-2007
Primary	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use	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.	01-January-2003 up to 31-December-2007
Primary	Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)		01-January-2003 up to 31-December-2007
Primary	Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)	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.	01-January-2003 up to 31-December-2007
Primary	Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)	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.	01-January-2003 up to 31-December-2007

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