Epidemiology Study of Non-arteritic Anterior Ischemic Opt... | NCT01260324

Label	Type	Description	Intervention Names
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.	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)	Other: No intervention given in this observational study

Name	Type	Description	Arm Group Labels	Other Names
No intervention given in this observational study	Other	No intervention given in this observational study	NAION cases

Measure	Description	Time Frame
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
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
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
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
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.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	NAION Cases	Nonarteritic anterior ischemic optic neuropathy (NAION). 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.

ID	Title	Description
BG000	NAION Cases	Nonarteritic anterior ischemic optic neuropathy (NAION). 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.
BG001	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)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0001283 BG00120000 BG00221283

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years [(NAION cases n, Controls n) / person-years].

Posted

Number

95% Confidence Interval

incidence rate per 1000 person-years

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	Combined NAION Cases and Controls	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. 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).

Units	Counts
Participants	OG00021283

Title

Denominators

Categories

Age 18 to 34 (n=43, 5,954) / 8,042,997

Title	Measurements
	OG0000.01(0.00 to 0.01)

Age 35 to 44 (n=59, 4,937) / 6,669,176

Title	Measurements
	OG0000.01(0.01 to 0.01)

Age 45 to 54 (n=208, 4,655) / 6,288,235

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Incidence rate Age 18 to 34					Incidence rate per 1000 person-years	0.01			2-Sided	95	0.01	0.01			Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.		Superiority or Other (legacy)
OG000

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.

Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Posted

Number

95% Confidence Interval

incidence rate per 1000 person-years

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	Combined NAION Cases and Controls	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. 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).

Units	Counts
Participants

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.

Posted

Number

95% Confidence Interval

incidence rate per 1000 person-years

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	Combined NAION Cases and Controls	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. 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).

Units	Counts
Participants

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.

Posted

Number

95% Confidence Interval

incidence rate per 1000 person-years

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	Combined NAION Cases and Controls	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. 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).

Units	Counts
Participants

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.

Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years]. Only the covariates selected by the step wise regression procedure were summarized.

Posted

Number

95% Confidence Interval

incidence rate per 1000 person-years

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	Combined NAION Cases and Controls	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. 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).

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).

Posted

Number

95% Confidence Interval

incidence rate per 1000 person-years

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	Combined NAION Cases and Controls	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. 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).

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.

Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years [(n=NAION cases, Controls) / person-years].

Posted

Number

95% Confidence Interval

incidence rate per 1000 person-years

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	Combined NAION Cases and Controls	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. 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).

Primary

Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)

Participants from the NAION cases population adjudicated by medical record review.

Posted

Number

participants

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	NAION Cases	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. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.

Units	Counts
Participants	OG000

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.

Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].

Posted

Number

95% Confidence Interval

incidence rate ratio

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	NAION Cases	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. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.

Units	Counts
Participants

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.

Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].

Posted

Number

95% Confidence Interval

incidence rate ratio

01-January-2003 up to 31-December-2007

ID	Title	Description
OG000	NAION Cases	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. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.

Units	Counts
Participants	OG000

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000	Incidence rate Other retinal disorders	Incidence rate per 1000 person-years	0.33	2-Sided	95	0.28	0.39	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Glaucoma	Incidence rate per 1000 person-years	0.13	2-Sided	95	0.11	0.16	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Cataract	Incidence rate per 1000 person-years	0.20	2-Sided	95	0.08	0.41	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Visual disturbances	Incidence rate per 1000 person-years	0.99	2-Sided	95	0.83	1.17	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Blindness and low vision	Incidence rate per 1000 person-years	2.00	2-Sided	95	1.60	2.46	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Other disorders of eye	Incidence rate per 1000 person-years	0.19	2-Sided	95	0.16	0.23	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Occlusion and stenosis of precerebral arteries	Incidence rate per 1000 person-years	0.22	2-Sided	95	0.18	0.27	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Acute sinusitis	Incidence rate per 1000 person-years	0.07	2-Sided	95	0.05	0.08	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Other dermatoses	Incidence rate per 1000 person-years	0.06	2-Sided	95	0.05	0.08	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Other disorders of bone and cartilage	Incidence rate per 1000 person-years	0.08	2-Sided	95	0.06	0.10	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Symptoms involving head and neck	Incidence rate per 1000 person-years	0.12	2-Sided	95	0.10	0.14	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Incidence rate Other ill defined and unknown causes of morbidity and mortality	Incidence rate per 1000 person-years	0.14	2-Sided	95	0.10	0.18	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.	Superiority or Other (legacy)
OG000	Odds ratio Other retinal disorders	Odds Ratio (OR)	6.65	2-Sided	95	4.72	9.38	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Glaucoma	Odds Ratio (OR)	2.60	2-Sided	95	1.77	3.81	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Cataract	Odds Ratio (OR)	1.31	2-Sided	95	1.02	1.68	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Visual disturbances	Odds Ratio (OR)	14.20	2-Sided	95	10.40	19.30	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Blindness and low vision	Odds Ratio (OR)	15.10	2-Sided	95	6.60	34.50	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Other disorders of eye	Odds Ratio (OR)	2.02	2-Sided	95	1.44	2.82	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Occlusion and stenosis of precerebral arteries	Odds Ratio (OR)	1.22	2-Sided	95	0.64	2.31	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Acute sinusitis	Odds Ratio (OR)	1.29	2-Sided	95	0.96	1.74	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Other dermatoses	Odds Ratio (OR)	1.34	2-Sided	95	1.02	1.77	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Other disorders of bone and cartilage	Odds Ratio (OR)	1.32	2-Sided	95	0.98	1.77	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Symptoms involving head and neck	Odds Ratio (OR)	1.37	2-Sided	95	1.02	1.84	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)
OG000	Odds ratio Ill defined and unknown causes of morbidity and mortality	Odds Ratio (OR)	1.64	2-Sided	95	1.08	2.49	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.	Superiority or Other (legacy)

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NAION Cases	Nonarteritic anterior ischemic optic neuropathy (NAION). 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.			0	1,283	0	1,283
EG001	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)			0	20,000	0	20,000