Trial Outcomes & Findings for Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) (NCT NCT01260324)
NCT ID: NCT01260324
Last Updated: 2021-02-01
Results Overview
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.
Recruitment status
COMPLETED
Target enrollment
21283 participants
Primary outcome timeframe
01-January-2003 up to 31-December-2007
Results posted on
2021-02-01
Participant Flow
Participant milestones
| Measure |
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)
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|---|---|---|
|
Overall Study
STARTED
|
1283
|
20000
|
|
Overall Study
COMPLETED
|
1283
|
20000
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Baseline characteristics by cohort
| Measure |
NAION Cases
n=1283 Participants
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
n=20000 Participants
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
n=21283 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
18 to 34 years
|
43 participants
n=5 Participants
|
5954 participants
n=7 Participants
|
5997 participants
n=5 Participants
|
|
Age, Customized
35 to 44 years
|
59 participants
n=5 Participants
|
4937 participants
n=7 Participants
|
4996 participants
n=5 Participants
|
|
Age, Customized
45 to 54 years
|
208 participants
n=5 Participants
|
4655 participants
n=7 Participants
|
4863 participants
n=5 Participants
|
|
Age, Customized
55 to 64 years
|
481 participants
n=5 Participants
|
3041 participants
n=7 Participants
|
3522 participants
n=5 Participants
|
|
Age, Customized
65 to 74 years
|
247 participants
n=5 Participants
|
902 participants
n=7 Participants
|
1149 participants
n=5 Participants
|
|
Age, Customized
≥75 years
|
245 participants
n=5 Participants
|
511 participants
n=7 Participants
|
756 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
595 Participants
n=5 Participants
|
10669 Participants
n=7 Participants
|
11264 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
688 Participants
n=5 Participants
|
9331 Participants
n=7 Participants
|
10019 Participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per calendar year
Year 2003
|
285 participants
n=5 Participants
|
3953 participants
n=7 Participants
|
4238 participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per calendar year
Year 2004
|
236 participants
n=5 Participants
|
3990 participants
n=7 Participants
|
4226 participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per calendar year
Year 2005
|
284 participants
n=5 Participants
|
4137 participants
n=7 Participants
|
4421 participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per calendar year
Year 2006
|
231 participants
n=5 Participants
|
4081 participants
n=7 Participants
|
4312 participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per calendar year
Year 2007
|
247 participants
n=5 Participants
|
3839 participants
n=7 Participants
|
4086 participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per region of United States
Northeast
|
100 participants
n=5 Participants
|
2456 participants
n=7 Participants
|
2556 participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per region of United States
Midwest
|
362 participants
n=5 Participants
|
5345 participants
n=7 Participants
|
5707 participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per region of United States
South
|
656 participants
n=5 Participants
|
9158 participants
n=7 Participants
|
9814 participants
n=5 Participants
|
|
Number of participants with NAION diagnosis per region of United States
West
|
165 participants
n=5 Participants
|
3041 participants
n=7 Participants
|
3206 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years \[(NAION cases n, Controls n) / person-years\].
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=21283 Participants
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.
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).
|
|---|---|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Age 18 to 34 (n=43, 5,954) / 8,042,997
|
0.01 incidence rate per 1000 person-years
Interval 0.0 to 0.01
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Age 35 to 44 (n=59, 4,937) / 6,669,176
|
0.01 incidence rate per 1000 person-years
Interval 0.01 to 0.01
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Age 45 to 54 (n=208, 4,655) / 6,288,235
|
0.03 incidence rate per 1000 person-years
Interval 0.03 to 0.04
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Age 55 to 64 (n=481, 3,041) / 4,107,953
|
0.12 incidence rate per 1000 person-years
Interval 0.11 to 0.13
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Age 65 to 74 (n=247, 902) / 1,218,472
|
0.20 incidence rate per 1000 person-years
Interval 0.18 to 0.23
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Age ≥75 (n=245, 511) / 690,287
|
0.35 incidence rate per 1000 person-years
Interval 0.31 to 0.4
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\].
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=21283 Participants
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.
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).
|
|---|---|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex
Female (n=595, 10,669) / 14,412,283
|
0.04 incidence rate per 1000 person-years
Interval 0.04 to 0.04
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex
Male (n=688, 9,331) / 12,604,837
|
0.05 incidence rate per 1000 person-years
Interval 0.05 to 0.06
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\].
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=21283 Participants
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.
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).
|
|---|---|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
Year 2003 (n=285, 3953) / 5,339,934
|
0.05 incidence rate per 1000 person-years
Interval 0.05 to 0.06
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
Year 2004 (n=236, 3,990) / 5,389,915
|
0.04 incidence rate per 1000 person-years
Interval 0.04 to 0.05
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
Year 2005 (n=284, 4,137) / 5,588,491
|
0.05 incidence rate per 1000 person-years
Interval 0.05 to 0.06
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
Year 2006 (n=231, 4,081) / 5,512,843
|
0.04 incidence rate per 1000 person-years
Interval 0.04 to 0.05
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
Year 2007 (n=247, 3,839) / 5,185,936
|
0.05 incidence rate per 1000 person-years
Interval 0.04 to 0.05
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\].
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=21283 Participants
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.
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).
|
|---|---|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region
Northeast (n=100, 2,456) / 3,317,702
|
0.03 incidence rate per 1000 person-years
Interval 0.02 to 0.04
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region
Midwest (n=362, 5,345) / 7,220,325
|
0.05 incidence rate per 1000 person-years
Interval 0.05 to 0.06
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region
South (n=656, 9,158) / 12,371,139
|
0.05 incidence rate per 1000 person-years
Interval 0.05 to 0.06
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region
West (n=165, 3,041) / 4,107,953
|
0.04 incidence rate per 1000 person-years
Interval 0.03 to 0.05
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\]. Only the covariates selected by the step wise regression procedure were summarized.
Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=21283 Participants
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.
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).
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|---|---|
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Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Diabetes (n=349, 1,131) / 1,527,818
|
0.23 incidence rate per 1000 person-years
Interval 0.21 to 0.25
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Smoking (n=48, 232) / 313,399
|
0.15 incidence rate per 1000 person-years
Interval 0.11 to 0.2
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Obesity (n=25, 273) / 368,784
|
0.07 incidence rate per 1000 person-years
Interval 0.04 to 0.1
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Nitrates (n=71, 171) / 230,996
|
0.31 incidence rate per 1000 person-years
Interval 0.24 to 0.39
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Anti-platelet agents (n=127, 182) / 245,856
|
0.52 incidence rate per 1000 person-years
Interval 0.43 to 0.61
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Diuretics (n=134, 296) / 399,853
|
0.34 incidence rate per 1000 person-years
Interval 0.28 to 0.4
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Recent PDE-5 inhibitors use (n=17, 202) / 272,873
|
0.06 incidence rate per 1000 person-years
Interval 0.04 to 0.1
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\].
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=21283 Participants
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.
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).
|
|---|---|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Other retinal disorders (n=337, 240) / 324,205
|
1.04 incidence rate per 1000 person-years
Interval 0.93 to 1.16
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Glaucoma (n=161, 353) / 476,852
|
0.34 incidence rate per 1000 person-years
Interval 0.29 to 0.39
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Cataract (n=245, 405) / 547,097
|
0.45 incidence rate per 1000 person-years
Interval 0.39 to 0.51
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Visual disturbances (n=291, 130) / 175,611
|
1.66 incidence rate per 1000 person-years
Interval 1.47 to 1.86
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Blindness and low vision (n=103, 11) / 14,859
|
6.93 incidence rate per 1000 person-years
Interval 5.66 to 8.41
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Other disorders of eye (n=143, 201) / 271,522
|
0.53 incidence rate per 1000 person-years
Interval 0.44 to 0.62
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Occlusion / Stenosis (n=98, 75) / 101,314
|
0.97 incidence rate per 1000 person-years
Interval 0.79 to 1.18
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Acute sinusitis (n=92, 1,123) / 1,517,011
|
0.06 incidence rate per 1000 person-years
Interval 0.05 to 0.07
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Other dermatoses (n=114, 536) / 724,059
|
0.16 incidence rate per 1000 person-years
Interval 0.13 to 0.19
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Bone and cartilage (n=114, 504) / 680,831
|
0.17 incidence rate per 1000 person-years
Interval 0.14 to 0.2
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Head and neck (n=181, 771) / 1,041,510
|
0.17 incidence rate per 1000 person-years
Interval 0.15 to 0.2
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Ill defined / Unknown causes (n=71, 183) / 247,207
|
0.29 incidence rate per 1000 person-years
Interval 0.22 to 0.36
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years \[(n=NAION cases, Controls) / person-years\].
Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=6219 Participants
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.
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).
|
|---|---|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
Recent use (n=17, 187) / 254,239
|
0.05 incidence rate per 1000 person-years
Interval 0.03 to 0.09
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
Any use (n=32, 322) / 437,780
|
0.06 incidence rate per 1000 person-years
Interval 0.04 to 0.09
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
Chronic use (n=16, 162) / 220,249
|
0.06 incidence rate per 1000 person-years
Interval 0.03 to 0.1
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
Non-chronic use (n=16, 160) / 217,530
|
0.07 incidence rate per 1000 person-years
Interval 0.04 to 0.11
|
|
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
Never use (n=631, 5,234) / 7,115,962
|
0.09 incidence rate per 1000 person-years
Interval 0.08 to 0.1
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Participants from the NAION cases population adjudicated by medical record review.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=74 Participants
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.
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).
|
|---|---|
|
Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)
Acute
|
35 participants
|
|
Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)
Unknown
|
35 participants
|
|
Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)
Intermittent
|
3 participants
|
|
Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)
Chronic
|
1 participants
|
PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years \[(n=NAION cases) / person-years\].
Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=57 Participants
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.
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).
|
|---|---|
|
Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Age 18 to 64 years (n=18) / 25.53
|
1.00 incidence rate ratio
Result value is the reference category for calculation of the rate ratio; CI not applicable.
|
|
Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Age ≥65 years (n=9) / 29.94
|
0.56 incidence rate ratio
Interval 0.25 to 1.25
|
|
Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Female (n=14) / 31.69
|
1.00 incidence rate ratio
Result value is the reference category for calculation of the rate ratio; CI not applicable.
|
|
Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Male (n=13) / 23.77
|
1.22 incidence rate ratio
Interval 0.57 to 2.62
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PRIMARY outcome
Timeframe: 01-January-2003 up to 31-December-2007Population: Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years \[(n=NAION cases) / person-years\].
Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
Outcome measures
| Measure |
Combined NAION Cases and Controls
n=74 Participants
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.
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).
|
|---|---|
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Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Age 18 to 64 years (n=2) / 66.63
|
1.00 incidence rate ratio
Result value is the reference category for calculation of the rate ratio; CI not applicable.
|
|
Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Age ≥65 years (n=1) / 57.39
|
0.62 incidence rate ratio
Interval 0.06 to 6.96
|
|
Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Female (n=1) / 66.05
|
1.00 incidence rate ratio
Result value is the reference category for calculation of the rate ratio; CI not applicable.
|
|
Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Male (n=2) / 57.97
|
2.03 incidence rate ratio
Interval 0.18 to 22.7
|
Adverse Events
NAION Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER