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

NCT ID: NCT01260324

Last Updated: 2021-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21283 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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)

Conditions

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Anterior Ischemic Optic Neuropathy Ischemic Optic Neuropathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No intervention given in this observational study

Intervention Type 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)

No intervention given in this observational study

Intervention Type OTHER

No intervention given in this observational study

Interventions

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No intervention given in this observational study

No intervention given in this observational study

Intervention Type OTHER

No intervention given in this observational study

No intervention given in this observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A1481282

Identifier Type: -

Identifier Source: org_study_id

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