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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT01260324

First received: November 5, 2010

Last updated: August 17, 2011

Last verified: August 2011

History of Changes

Results First Received: March 16, 2011

Study Type:	Observational
Study Design:	Observational Model: Case Control; Time Perspective: Retrospective
Conditions:	Anterior Ischemic Optic Neuropathy Ischemic Optic Neuropathy
Intervention:	Other: No intervention given in this observational study

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

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.

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)

Participant Flow: Overall Study

	NAION Cases	Controls
STARTED	1283	20000
COMPLETED	1283	20000
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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.
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)
Total	Total of all reporting groups

Baseline Measures

	NAION Cases	Controls	Total
Number of Participants [units: participants]	1283	20000	21283
Age, Customized [units: participants]
18 to 34 years	43	5954	5997
35 to 44 years	59	4937	4996
45 to 54 years	208	4655	4863
55 to 64 years	481	3041	3522
65 to 74 years	247	902	1149
≥75 years	245	511	756
Gender [units: participants]
Female	595	10669	11264
Male	688	9331	10019
Number of participants with NAION diagnosis per calendar year ^[1] [units: participants]
Year 2003	285	3953	4238
Year 2004	236	3990	4226
Year 2005	284	4137	4421
Year 2006	231	4081	4312
Year 2007	247	3839	4086
Number of participants with NAION diagnosis per region of United States ^[1] [units: participants]
Northeast	100	2456	2556
Midwest	362	5345	5707
South	656	9158	9814
West	165	3041	3206

[1]	Medical record-adjudicated definite and possible cases and claims algorithm-derived definite and possible cases.

Outcome Measures

Show All Outcome Measures

1. Primary:

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 ]

Show Outcome Measure 1

2. Primary:

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 ]

Show Outcome Measure 2

3. Primary:

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 ]

Show Outcome Measure 3

4. Primary:

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 ]

Show Outcome Measure 4

5. Primary:

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 ]

Hide Outcome Measure 5

Measure Type	Primary
Measure Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Measure Description	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.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Description

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).

Measured Values

	Combined NAION Cases and Controls
Number of Participants Analyzed [units: participants]	21283
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors [units: incidence rate per 1000 person-years] Number ( 95% Confidence Interval )
Diabetes (n=349, 1,131) / 1,527,818	0.23 ( 0.21 to 0.25 )
Smoking (n=48, 232) / 313,399	0.15 ( 0.11 to 0.20 )
Obesity (n=25, 273) / 368,784	0.07 ( 0.04 to 0.10 )
Nitrates (n=71, 171) / 230,996	0.31 ( 0.24 to 0.39 )
Anti-platelet agents (n=127, 182) / 245,856	0.52 ( 0.43 to 0.61 )
Diuretics (n=134, 296) / 399,853	0.34 ( 0.28 to 0.40 )
Recent PDE-5 inhibitors use (n=17, 202) / 272,873	0.06 ( 0.04 to 0.10 )

Statistical Analysis 1 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.09
95% Confidence Interval	( 0.08 to 0.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Diabetes
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.11
95% Confidence Interval	( 0.08 to 0.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Smoking
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.04
95% Confidence Interval	( 0.03 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Obesity
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.07
95% Confidence Interval	( 0.06 to 0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Nitrates
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.15
95% Confidence Interval	( 0.12 to 0.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Anti-platelet agents
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.13
95% Confidence Interval	( 0.09 to 0.17 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Diuretics
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 7 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.03
95% Confidence Interval	( 0.01 to 0.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Recent PDE-5 inhibitors use
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 8 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.82
95% Confidence Interval	( 1.47 to 2.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Diabetes
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 9 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.34
95% Confidence Interval	( 0.63 to 2.85 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Smoking
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 10 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.43
95% Confidence Interval	( 0.23 to 0.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Obesity
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 11 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.63
95% Confidence Interval	( 0.42 to 0.94 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Nitrates
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 12 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	2.12
95% Confidence Interval	( 1.53 to 2.94 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Anti-platelet agents
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 13 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	2.24
95% Confidence Interval	( 1.46 to 3.43 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Diuretics
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 14 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.57
95% Confidence Interval	( 0.31 to 1.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Recent PDE-5 inhibitors use
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

6. Primary:

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 ]

Show Outcome Measure 6

7. Primary:

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 ]

Show Outcome Measure 7

8. Primary:

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 ]

Show Outcome Measure 8

9. Primary:

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 ]

Show Outcome Measure 9

10. Primary:

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 ]

Show Outcome Measure 10

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01260324 History of Changes
Other Study ID Numbers:	A1481282
Study First Received:	November 5, 2010
Results First Received:	March 16, 2011
Last Updated:	August 17, 2011
Health Authority:	United States: Institutional Review Board

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