Age-Related Macular Degeneration and Cataract

Cataract Clinical Trial

Official title:

Age-Related Eye Disease Study - Follow-Up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001312
• Other study ID #: 920250
• Secondary ID: 92-EI-0250
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: January 28, 2010
• Start date: August 1992

Study information

• Verified date: March 2008
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Clouding of the lens, or cataract formation, accounts for vision loss in about 45 percent of the U.S. population aged 75 to 85 years. Macular degeneration-destruction of the part of the retina responsible for central vision used in reading-is the leading cause of legal blindness in people over 60 years of age.

This 10-year study on age-related macular degeneration and cataract will investigate:

1. The natural course and prognosis of these diseases;

2. The effects of vitamin and mineral supplements on their development and progression; and

3. Risk factors associated with their development.

Patients with age-related macular degeneration or cataract will be evaluated for their eligibility in this study with a medical history, vision test and thorough eye examination, including photographs of the lens and back of the eye. Those accepted to the study will be randomly assigned to take one of the following 4 times a day: 1) a vitamin only; 2) a mineral only; 3) both a vitamin and a mineral; or 4) a placebo (a tablet with no active ingredient). A blood sample will be drawn at the beginning of the study and once a year until its end to measure vitamin and mineral blood levels and to study their effects on cholesterol. Participants will be asked to complete a voluntary questionnaire about their visual function and how it affects their daily lives.

Some patients may be asked to participate in two interviews about 6 months apart, in which they will provide information on their food intake over a 24-hour period. This information will be used to explore possible dietary risk factors for macular degeneration and cataract. Participants may also be asked to provide a small blood sample for use in studying possible hereditary factors associated with age-related macular degeneration. This research may lead to a better understanding of why the condition develops, who is likely to be affected and to what degree, and how to improve treatment.

Description:

The purpose of this ancillary study is to evaluate the feasibility of studying zinc metabolism in Age-Related Eye Disease Study (AREDS) participants. All 127 AREDS participants currently followed by the National Eye Institute Clinical Center will be approached for consent. In addition to the assessment of zinc functional status, parameters of antioxidant defense and immune function capacities will be measured in consenting participants to describe the effects of zinc supplementation on these measures in this population. Results from this pilot study will be used to evaluate the feasibility of expanding enrollment to participants from other AREDS clinical centers.

Other known NCT identifiers

• NCT00000145

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

• INCLUSION CRITERIA:

To be eligible for enrollment, potential participants must meet all of the following criteria:

Enrolled in AREDS

Followed by the NEI Clinical Center

Signed the informed consent statement for this Ancillary study.

EXCLUSION CRITERIA:

Demonstrated inability to comply with blood drawing procedures.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Macular Degeneration

Intervention

Drug:
• Vitamin and/or Mineral Supplement

• Vitamins and Minerals

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	University of Wisconsin	Madison	Wisconsin
United States	Eye and Ear Institute of Pittsburgh	Pittsburgh	Pennsylvania
United States	Deavers Eye Institute	Portland	Oregon
United States	Associated Retinal Consultants, PC	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Leibowitz HM, Krueger DE, Maunder LR, Milton RC, Kini MM, Kahn HA, Nickerson RJ, Pool J, Colton TL, Ganley JP, Loewenstein JI, Dawber TR. The Framingham Eye Study monograph: An ophthalmological and epidemiological study of cataract, glaucoma, diabetic retinopathy, macular degeneration, and visual acuity in a general population of 2631 adults, 1973-1975. Surv Ophthalmol. 1980 May-Jun;24(Suppl):335-610. — View Citation