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
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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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.
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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
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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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


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