Age-Related Eye Disease Study 2 (AREDS2) 10-year Follow-On

NCT03367767 | Completed

• 2 other identifiers: 18002318-EI-0023
• Study Type: observational
• Target: 709
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Age-related macular degeneration (AMD) and cataracts are two eye diseases. They were studied in the Age-Related Eye Disease Study (AREDS2) and the AREDS2 Follow-On study. These studies followed the natural course of the diseases. They also provided data on the long-term effects of certain oral supplements on AMD. Objective: To study the long-term effects of oral supplements on several things. These include incidences of lung cancer, development of late AMD, cataract surgery, cognitive function, and cardiovascular events. Eligibility: Former AREDS2 and AREDS2 Follow-On participants Design: Participants will have 1 visit. It will include: An eye exam that tests how well participants can see, measures eye pressure, and checks eye movements. The pupil will be dilated with eye drops. Pictures will be taken of the retina and the inside of the eye. Participants will grip a device in their hand to measure their grip strength. A blood sample will be taken. This will be stored for future genetic research. Cells may be created from the sample. A small sample of skin will be taken. Sponsoring Institution: National Eye Institute

Conditions

AMD; Cancer; Cataract

Keywords

Blood Sample; Medical History; Optical Imaging

Outcome Measures

Primary Outcomes (1)

• The incidence of advanced AMD, cataract surgery and lung cancer will be the primary outcomes of the study.

  Study Completion

Secondary Outcomes (1)

• Participant reports of incident cardiovascular events will be collected as secondary outcomes.

  Study Completion

Study Arms (1)

1

Former AREDS2 and AREDS2 Follow-On participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Former AREDS2 and AREDS2 Follow-On participants

You may qualify if:

• To participate in this study, the potential participant must meet all of the following criteria:
• Previously enrolled in the AREDS2 and AREDS2 Follow-on protocols.
• Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form s contents and provide written informed consent.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Neoplasms; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Emily Y Chew, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 11, 2017
• Study Start: May 23, 2018
• Primary Completion: March 21, 2019
• Study Completion: March 21, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

US (1)