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Analyses of Existing Framingham Data

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier:
NCT00342810
First received: June 19, 2006
Last updated: November 11, 2014
Last verified: May 2014
  Purpose

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
Eye Diseases

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Continued Analyses of Epidemiologic Risk Factors Using Existing Framingham Eye and Heart Study Data

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Explore associations using study data

Estimated Enrollment: 6061
Study Start Date: June 2003
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342810

Locations
United States, Maryland
National Eye Institute (NEI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Susan Vitale, Ph.D. National Eye Institute (NEI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT00342810     History of Changes
Other Study ID Numbers: 999903232, 03-EI-N232
Study First Received: June 19, 2006
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Eye Diseases

Additional relevant MeSH terms:
Eye Diseases

ClinicalTrials.gov processed this record on November 27, 2014