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

November 3, 1999
January 28, 2010
August 1992
March 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00001312 on ClinicalTrials.gov Archive Site
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Age-Related Macular Degeneration and Cataract
Age-Related Eye Disease Study - Follow-Up

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.

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.

Interventional
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Primary Purpose: Treatment
  • Cataract
  • Macular Degeneration
  • Drug: Vitamin and/or Mineral Supplement
  • Drug: Vitamins and Minerals
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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March 2008   (final data collection date for primary outcome measure)
  • 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.

Both
55 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001312
920250, 92-EI-0250
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National Eye Institute (NEI)
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National Institutes of Health Clinical Center (CC)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP