Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000157
Status:
TERMINATED
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Randomized Trial of Aspirin and Cataracts in US Physicians
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of developing cataract among male US physicians who were aged 40 to 84 in 1982
To identify potential risk factors for cataract development such as age blood pressure blood cholesterol height diabetes medication use and history of previous eye trauma or surgery
To identify potential risk factors for cataract development such as age blood pressure blood cholesterol height diabetes medication use and history of previous eye trauma or surgery
Detailed Description:
Cataract is one of the most common causes of impaired vision as well as the third leading cause of blindness in the United States Cataract surgery is one of the safest and most successful of all operations The National Eye Institute has estimated that if the progression of cataract could be slowed enough to delay the need for surgery by even 10 years the current annual number could be reduced by 45 percent
Little is known about the relative importance of various potential risk factors in the development of cataract Most current information on risk factors has come from anecdotal reports or from relatively small case-control studies One major project the Framingham Eye Study has identified several factors that were significantly associated with subsequent cataract formation including diabetes and dietary factors Diabetes has long been thought to increase the risk of developing cataract
Recently aspirin has been proposed as a drug that can prevent cataract formation or slow its progression Aspirin may affect tryptophan levels in patients with cataract or it may inhibit aldose reductase an enzyme associated with the development of diabetic cataract Thus data from this study sought to determine whether one 325-mg aspirin tablet taken on alternate days protects against cataract formation The data also sought to reveal other additional cataract risk factors that emerge after simultaneous controlling for other variables
The other primary objective of this trial was to assess the antioxidant effects of beta-carotene 50 mg on alternate days on cataract development In addition factors that have been suggested to be cataractogenic were assessed in prospective cohort studies These factors included age blood pressure blood cholesterol height diabetes medication use cigarette smoking and history of previous eye trauma or surgery In addition the possible associations between history of vitamin E and selenium intake and cataract were explored
This trial was part of the Physicians Health Study an ongoing randomized placebo-controlled clinical trial of aspirin in the prevention of cardiovascular mortality and of beta-carotene in the prevention of cancer Following randomization each of the 22071 physicians enrolled was assigned to one of four groups to take either aspirin or its placebo and beta-carotene or its placebo Follow-up questionnaires were sent 6 and 12 months after randomization and every 12 months thereafter The randomized aspirin component of the trial was terminated early January 1988 after an average followup of approximately 5 years because of a statistically extreme 44 percent reduced risk of a first myocardial infarction in the aspirin group
Since this study is conducted by mail among physicians nationwide examinations cannot be performed on all patients to determine when they have reached an end point Reported diagnoses of cataract are confirmed by medical record review The primary analysis will be of incidence of cataract in the aspirin and placebo groups In addition the Cox proportional hazards model will be used to determine whether there is a difference in time to cataract diagnosis between the two groups It has been postulated that the potent antioxidant properties of beta-carotene might make it effective in preventing cataract development The investigators will thus determine whether there is a difference in the numbers of cataracts between the beta-caroteneplacebo groups and the aspirinplacebo groups
Little is known about the relative importance of various potential risk factors in the development of cataract Most current information on risk factors has come from anecdotal reports or from relatively small case-control studies One major project the Framingham Eye Study has identified several factors that were significantly associated with subsequent cataract formation including diabetes and dietary factors Diabetes has long been thought to increase the risk of developing cataract
Recently aspirin has been proposed as a drug that can prevent cataract formation or slow its progression Aspirin may affect tryptophan levels in patients with cataract or it may inhibit aldose reductase an enzyme associated with the development of diabetic cataract Thus data from this study sought to determine whether one 325-mg aspirin tablet taken on alternate days protects against cataract formation The data also sought to reveal other additional cataract risk factors that emerge after simultaneous controlling for other variables
The other primary objective of this trial was to assess the antioxidant effects of beta-carotene 50 mg on alternate days on cataract development In addition factors that have been suggested to be cataractogenic were assessed in prospective cohort studies These factors included age blood pressure blood cholesterol height diabetes medication use cigarette smoking and history of previous eye trauma or surgery In addition the possible associations between history of vitamin E and selenium intake and cataract were explored
This trial was part of the Physicians Health Study an ongoing randomized placebo-controlled clinical trial of aspirin in the prevention of cardiovascular mortality and of beta-carotene in the prevention of cancer Following randomization each of the 22071 physicians enrolled was assigned to one of four groups to take either aspirin or its placebo and beta-carotene or its placebo Follow-up questionnaires were sent 6 and 12 months after randomization and every 12 months thereafter The randomized aspirin component of the trial was terminated early January 1988 after an average followup of approximately 5 years because of a statistically extreme 44 percent reduced risk of a first myocardial infarction in the aspirin group
Since this study is conducted by mail among physicians nationwide examinations cannot be performed on all patients to determine when they have reached an end point Reported diagnoses of cataract are confirmed by medical record review The primary analysis will be of incidence of cataract in the aspirin and placebo groups In addition the Cox proportional hazards model will be used to determine whether there is a difference in time to cataract diagnosis between the two groups It has been postulated that the potent antioxidant properties of beta-carotene might make it effective in preventing cataract development The investigators will thus determine whether there is a difference in the numbers of cataracts between the beta-caroteneplacebo groups and the aspirinplacebo groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None