NCT00342342

Brief Summary

This study will examine blood specimens from patients with various eye disorders who previously participated in the Beaver Dam Eye Study to try to identify genes responsible for these disorders. The Beaver Dam study was designed to determine the incidence and causes of age-related eye conditions, including cataract (changes in the lens of the eye that can impair vision); retinopathy (diseases of the retina - the thin layer of tissue that lines the back of the eye); age-related maculopathy (degeneration or atrophy of the macula - the center part of the retina responsible for fine vision); and impaired vision. Findings from this study and others have shown that age-related eye disorders often run in families, indicating a genetic component in their development. All participants in the Beaver Dam study who had family members in the study may be included in the current NHGRI study. The Beaver Dam study included residents of the township of Beaver Dam, Wisconsin, who were between 45 and 84 years of age at enrollment. Participants had thorough eye examinations and blood samples drawn at baseline and 5 and 10 years after the baseline evaluation. Fifteen-year follow-ups will start in 2003. This study will analyze data and blood samples previously collected from Beaver Dam study participants to identify genes related to numerous age-related visual traits. No new participants will be recruited.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2002

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

17.4 years

First QC Date

June 19, 2006

Last Update Submit

April 20, 2020

Conditions

CataractsGlaucomaMyopia

Keywords

AssociationLinkage StudyFamilial AggregationLinkage Disequilibrium

Outcome Measures

Primary Outcomes (1)

  • Refractive error

    ocular refractive error was measured on both eyes at enrollment in both the BDES and FES

    At study enrollment

Study Arms (2)

Beaver Dam Eye Study

Individuals over 45 years of age enrolled in Beaver Dam Wisconsin

Framingham Eye Study

Subset of individuals from the Framingham Heart Study who received eye examinations

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Beaver Dam Eye study used a community sample.@@@Framingham Eye study used a subset of a community sample.

You may qualify if:

  • All individuals aged 45-84 years of age living in the township of Beaver Dam Wisconsin were invited to participate.

You may not qualify if:

  • In the Framingham Eye Study, enrollees from the FHS who were deceased at the time of the FES exams (1970's) would not be able to enroll.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Boston University

Boston, Massachusetts, 02118-2354, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106-2602, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (3)

  • Tielsch JM, Sommer A, Witt K, Katz J, Royall RM. Blindness and visual impairment in an American urban population. The Baltimore Eye Survey. Arch Ophthalmol. 1990 Feb;108(2):286-90. doi: 10.1001/archopht.1990.01070040138048.

    PMID: 2271016BACKGROUND

  • Klein R, Wang Q, Klein BE, Moss SE, Meuer SM. The relationship of age-related maculopathy, cataract, and glaucoma to visual acuity. Invest Ophthalmol Vis Sci. 1995 Jan;36(1):182-91.

    PMID: 7822146BACKGROUND

  • Hiller R, Sperduto RD, Ederer F. Epidemiologic associations with nuclear, cortical, and posterior subcapsular cataracts. Am J Epidemiol. 1986 Dec;124(6):916-25. doi: 10.1093/oxfordjournals.aje.a114481.

    PMID: 3776974BACKGROUND

MeSH Terms

Conditions

CataractGlaucomaMyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesOcular HypertensionRefractive Errors

Study Officials

  • Joan Bailey-Wilson, Ph.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

December 4, 2002

Primary Completion

April 17, 2020

Study Completion

April 17, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations

US(5)