Age-Related Macular Degeneration and Cataract

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001312
First received: November 3, 1999
Last updated: January 28, 2010
Last verified: March 2008
  Purpose

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.


Condition Intervention
Cataract
Macular Degeneration
Drug: Vitamin and/or Mineral Supplement
Drug: Vitamins and Minerals

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Age-Related Eye Disease Study - Follow-Up

Resource links provided by NLM:


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

Estimated Enrollment: 200
Study Start Date: August 1992
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  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: NCT00001312

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322-1102
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426-3591
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201-1595
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114-3096
United States, Michigan
Associated Retinal Consultants, PC
Royal Oak, Michigan, United States, 48073
United States, New York
Albany Medical College
Albany, New York, United States, 12208
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oregon
Deavers Eye Institute
Portland, Oregon, United States, 97210-3065
United States, Pennsylvania
Eye and Ear Institute of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2582
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00001312     History of Changes
Obsolete Identifiers: NCT00000145
Other Study ID Numbers: 920250, 92-EI-0250
Study First Received: November 3, 1999
Last Updated: January 28, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Age-Related Macular Degeneration
Cataracts
Natural History Study
Clinical Trial
Randomized
Vitamins
Minerals
Serum Zinc Levels
Oxidative Stress Defense

Additional relevant MeSH terms:
Macular Degeneration
Cataract
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014