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

Completed

• Conditions: Anterior Ischemic Optic Neuropathy; Ischemic Optic Neuropathy
• Interventions: Other: No intervention given in this observational study

• Registration Number: NCT01260324
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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)

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Results First Submitted: 2011-03-16
• Results First Submitted QC: 2011-03-16
• Results First Posted: 2011-04-25
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21283

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	No intervention given in this observational study	From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
NAION cases	No intervention given in this observational study	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.

Primary Outcome Measures

Name	Time	Method
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region	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.
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
Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)	01-January-2003 up to 31-December-2007	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.
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use	01-January-2003 up to 31-December-2007	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.
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age	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	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	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 Baseline Risk Factors	01-January-2003 up to 31-December-2007	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	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). 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).
Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)	01-January-2003 up to 31-December-2007	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.