Macular Pigment and Glare Disability

Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study

The purpose of this study is:

I. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.

II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions.

III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.

IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.

The following measurements will be taken, before and after supplementation with lutein and zeaxanthin:

Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.

Inclusion Criteria:

• Gender: male or female
• Age: 18 - 40 years
• BMI: 20-30
• No anticipated changes in dieting habits (as relevant to xanthophyll intake).
• No anticipated surgical procedures.
• Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.
• Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
• Corrected visual acuity (ETDRS): better than 20/60

Exclusion Criteria:

• BMI <20 or >30
• Age <18 or >40 years
• Smokers
• Current or history of relevant diseases (such as AMD)
• Corrected visual acuity worse than 20/60
• Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
• Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
• Current use of xanthophyll containing supplements
• Use of xanthophyll containing supplements in the past 6 months
• Participation in any other study during last 1 month.
• Blood donation during the last 3 months.
• Known hypersensitivity or allergy to xanthophylls.
• Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
• Suspected lack of compliance with any requirements of the study.
• Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).
• Current pregnancy or breast feeding
• Any relevant abnormalities in the routine laboratory tests