Analyses of Existing Framingham Data

Eye Diseases Clinical Trial

Official title:

Continued Analyses of Epidemiologic Risk Factors Using Existing Framingham Eye and Heart Study Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00342810
• Other study ID #: 999903232
• Secondary ID: 03-EI-N232
• Status: Completed
• Start date: June 25, 2003
• Est. completion date: April 25, 2018

Study information

• Verified date: April 25, 2018
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6061
• Est. completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Eye Diseases

Locations

Country	Name	City	State
United States	National Eye Institute (NEI), 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ederer F, Hiller R, Taylor HR. Senile lens changes and diabetes in two population studies. Am J Ophthalmol. 1981 Mar;91(3):381-95. — View Citation

Hiller R, Sperduto RD, Podgor MJ, Ferris FL 3rd, Wilson PW. Diabetic retinopathy and cardiovascular disease in type II diabetics. The Framingham Heart Study and the Framingham Eye Study. Am J Epidemiol. 1988 Aug;128(2):402-9. — View Citation

Sperduto RD, Hiller R. The prevalence of nuclear, cortical, and posterior subcapsular lens opacities in a general population sample. Ophthalmology. 1984 Jul;91(7):815-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explore associations using study data		Continuous