Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
NCT01260324
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Adult Trials: 18+ Years
- 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
- 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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| 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 |
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| Intervention | Other: No intervention given in this observational study
No intervention given in this observational study | |||
| Study Groups/Cohorts |
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| 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 | 21283 | |||
| Original Actual Enrollment | 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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| PRS Account | Pfizer | |||
| Verification Date | August 2011 | |||