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



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