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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00594672 |
This study is a 5-year extension of the AREDS protocol, in which investigators followed the natural course of age-related macular degeneration (AMD) and cataracts. Participants in the former AREDS protocol are eligible for this study.
Participants have a complete eye examination once a year and are contacted at least once a year between visits to check on their status. The eye examination includes measurement of visual acuity (vision chart test) and examination of the inside of the eye after the pupils have been dilated with eye drops. Photographs of the inside of the eye may be taken using a special camera that flashes a bright light in the eye. A blood sample may be obtained to test for cholesterol level and genes related to inflammation.
Condition |
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Age-Related Macular Degeneration Cataract |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Age-Related Eye Disease Study (AREDS) Follow-Up |
Estimated Enrollment: | 105 |
Study Start Date: | January 2008 |
The Age-Related Eye Disease Study (AREDS) Follow-Up protocol allows us to continue with the follow-up of participants who were enrolled in the clinical trial of antioxidant vitamins and zinc. AREDS study was designed in the beginning to determine the clinical course and prognosis of age-related macular degeneration (AMD) and cataracts. In addition, AREDS evaluated the possible risk factors associated with the development of AMD and cataracts; the nutritional risk factors were evaluated and published in October, 2001.
Study results showed that antioxidant vitamins and zinc therapy reduced the risk of developing advanced AMD in participants with intermediate and greater risk of developing AMD (categories 3 and 4) by 25%. The risk of vision loss of three lines or more on the logarithmic visual acuity charts was also reduced by 19% for these participants. For those who developed AMD, their risk of vision loss was reduced by 25%. Antioxidants and zinc are now recommended for participants who have an intermediate risk of developing advanced AMD.
Upon completion of the clinical trial in September, 2001, participants were invited for follow-up for an additional five years to collect further data on the natural course of both AMD and cataracts. Although the multi-center trial was complete in December, 2005, we wish to continue to follow these participants for an additional five years to collect additional data. Of the 125 former participants that attended the close-out meeting for AREDS, 105 agreed to participate in a further extension of follow-up.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Participants will be eligible if they:
EXCLUSION CRITERIA:
Participants will not be eligible if they:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 080043, 08-EI-0043 |
Study First Received: | January 4, 2008 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00594672 |
Health Authority: | United States: Federal Government |
Age-Related Macular Degeneration (AMD) Cataracts Age Related Macular Degeneration AMD Cataract |
Eye Diseases Cataract Retinal Degeneration Macular Degeneration |
Lens Diseases Retinal Diseases Retinal degeneration |