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

NCT01260324

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anterior Ischemic Optic Neuropathy, Ischemic Optic Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Anterior Ischemic Optic Neuropathy, Ischemic Optic NeuropathyEpidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
NCT01260324
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Official Title The Detection and Epidemiology of NAION in a Commercially Insured Population in the United States.
Brief Summary The objectives of this study were to: (1) evaluate the natural history of non-arteritic anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION; and (3) identify potential risk factors for NAION.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Anterior Ischemic Optic Neuropathy
  • Ischemic Optic Neuropathy
Intervention Other: No intervention given in this observational study
No intervention given in this observational study
Study Groups/Cohorts
  • 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.
    Intervention: 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)
    Intervention: Other: No intervention given in this observational study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 9, 2011)
21283
Original Actual Enrollment
 (submitted: December 13, 2010)
1283
Actual Study Completion Date March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01260324
Other Study ID Numbers A1481282
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2011