Study of the Effects of Supplements on Eye Disease in Participants From the Age-Related Eye Disease Study

NCT01915238 | Completed

• 2 other identifiers: 13017913-EI-0179
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

Background: \- The Age-Related Eye Disease 2 Study (AREDS2) looked at two eye diseases. These were age-related macular degeneration (AMD) and cataracts. Participants in that study took supplement pills and some participants had additional pictures taken of their eyes. That study is now over. Researchers want to do a follow-up study after participants finish taking the pills, to see if they cause long-term effects on AMD. This study will be combined with follow-up visits of the AREDS2 study if possible. Objectives: \- To learn more about the effect of oral supplements on AMD. Eligibility: \- People who completed the AREDS2 study. Design:

• Participants will have up to 2 study visits over 6 18 months.
• Each visit will last up to 5 hours. The visits will be combined with annual follow-up visits in the AREDS2 study if possible.
• At each visit, participants will undergo an eye exam and photography.
• The eye exam includes testing sight, measuring eye pressure, and checking eye movements. To examine the inside of the eye, the pupil will be dilated with eye drops.
• Photographs of the inside of the eye may be taken during the eye exam and while the eyes are dilated.
• A contact lens may be placed on the eye briefly to look at the retina at the back of the eye.

Conditions

AMD; Age- Related Macular Degeneration

Keywords

Age-Related Macular Degeneration (AMD); AMD

Outcome Measures

Primary Outcomes (1)

• Vision loss outcome measure is mean change in visual acuity by Early Treatment Diabetic Retinopathy (ETDRS) score.

  1 year

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be eligible if they:
• Were enrolled in the AREDS2 protocol and successfully completed the final AREDS2 follow-up visit.
• Can understand and provide informed consent.

You may not qualify if:

• Participants will not be eligible if they:
• \. Are not able to return to NIH for examination for follow up visits.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Duke Univiversity Eye Center

Durham, North Carolina, United States

Location

Related Publications (2)

• AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.

  PMID: 22840421 BACKGROUND

• Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013 May 15;309(19):2005-15. doi: 10.1001/jama.2013.4997.

  PMID: 23644932 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Wai T Wong, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: July 16, 2013
• Primary Completion: June 20, 2014
• Study Completion: June 20, 2014
• Last Updated: August 30, 2017

Record last verified: 2014-06-20

Locations

US (2)