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Age-Related Eye Disease Study (AREDS) Follow-Up
This study is currently recruiting participants.
Verified December 2011 by National Institutes of Health Clinical Center (CC)

First Received on January 4, 2008.   Last Updated on December 21, 2011   History of Changes
Sponsor: National Eye Institute (NEI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00594672
  Purpose

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
Age-Related Macular Degeneration
Cataract

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Age-Related Eye Disease Study (AREDS) Follow-Up

Resource links provided by NLM:


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

Estimated Enrollment: 105
Study Start Date: January 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Participants will be eligible if they:

  • Were enrolled in the AREDS protocol and successfully completed the final AREDS follow-up visit.
  • Can understand and provide informed consent.

EXCLUSION CRITERIA:

Participants will not be eligible if they:

  • Are under the age of 50.
  • Are not able to return to NIH for examination for the duration of the trial.
  • Have any systemic diseases that compromise the ability to provide adequate ophthalmologic examination.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594672

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact            
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00594672     History of Changes
Other Study ID Numbers: 080043, 08-EI-0043
Study First Received: January 4, 2008
Last Updated: December 21, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Age-Related Macular Degeneration (AMD)
Cataracts
Age Related Macular Degeneration
AMD
Cataract

Additional relevant MeSH terms:
Eye Diseases
Macular Degeneration
Cataract
Retinal Degeneration
Retinal Diseases
Lens Diseases

ClinicalTrials.gov processed this record on February 09, 2012