- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01260324
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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)
|
No intervention given in this observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
01-January-2003 up to 31-December-2007
|
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.
|
01-January-2003 up to 31-December-2007
|
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.
|
01-January-2003 up to 31-December-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.
|
01-January-2003 up to 31-December-2007
|
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
|
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
|
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
|
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).
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01-January-2003 up to 31-December-2007
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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
|
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
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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
|
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)
Time Frame: 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.
|
01-January-2003 up to 31-December-2007
|
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
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A1481282
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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