Analyses of Existing Framingham Data

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00342810
Collaborator
(none)
6,061
1
178
34

Study Details

Study Description

Brief Summary

Since 1948, the Framingham Study has examined a group of men and women every two years for the primary purpose of studying the incidence and prevalence of cardiovascular disease and its risk factors. In 1971 the Framingham Study began a study of the offspring of the original group, including data collection on blood pressure, cigarette smoking, weight, and other factors that are of interest to studies of eye disease. Researchers gave eye exams to some of the original group and to the offspring group. Data from these eye exams have been used to examine risk factors for cataracts, diabetic retinopathy, myopia, and glaucoma.

The purpose of this study is to use the previously collected data for continued research on eye-related disorders. No new eye examinations will be conducted.

...

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We propose to continue to analyze existing Framingham Eye and Heart Study data to identify possible risk factors for various eye diseases. Originally begun in 1948 by the National Heart, Lung and Blood Institute (NHLBI), the Framingham Heart Study has been examining a population-based cohort of men and women biennially since 1948 for the primary purpose of studying the incidence and prevalence of cardiovascular disease and its risk factors. In 1971 the Heart Study began a prospective study of the offspring of the original cohort. The Heart Study has collected data on blood pressure, cigarette smoking, weight and many other factors of interest for epidemiologic studies of eye disease. Eye examinations were conducted on the survivors of the original cohort in a collaborative effort between the NEI and the NHLBI between 1973 and 1975 (Framingham Eye Study I; FES I) and then again between 1986 and 1989 (Framingham Eye Study II; FES II). Eye examinations were conducted on the Offspring Cohort from 1989 to 1991 (Framingham Offspring Eye Study; FOES). The Framingham data are unique in allowing epidemiologic studies with both cross sectional and longitudinal designs. Over the years, data from the Heart Study and the various eye studies have been used to examine demographic and risk factor characteristics for cataract, diabetic retinopathy, myopia, and glaucoma. To date this collaborative effort has yielded 31 publications by the National Eye Institute's Division of Epidemiology and Clinical Research; Rita Hiller is an author of 11. This proposal is for the continued use of the previously collected Framingham data. All studies will be done in collaboration with Heart Study investigators from Boston University which manages the study and conducts annual IRB reviews. No new eye examinations will be done.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    6061 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Continued Analyses of Epidemiologic Risk Factors Using Existing Framingham Eye and Heart Study Data
    Study Start Date :
    Jun 25, 2003
    Study Completion Date :
    Apr 25, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Explore associations using study data [Continuous]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • This study is of existing ocular data from the Framingham Eye Study. Since the participants have already been recruited, there are no further exclusions from the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Eye Institute (NEI), 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Susan Vitale, Ph.D., National Eye Institute (NEI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Eye Institute (NEI)
    ClinicalTrials.gov Identifier:
    NCT00342810
    Other Study ID Numbers:
    • 999903232
    • 03-EI-N232
    First Posted:
    Jun 21, 2006
    Last Update Posted:
    Dec 17, 2019
    Last Verified:
    Apr 25, 2018
    Keywords provided by National Eye Institute (NEI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 17, 2019