Night Vision and Carotenoids

Study Overview
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Brief Summary
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Vision at twilight and night is more difficult and dangerous for the entire population, even more so for the elderly and especially for the elderly with degenerative disease. Multiple worldwide laboratories have demonstrated the ability to raise macular pigment optical density with dietary carotenoids. This proposal further evaluates the relationship between macular re- pigmentation and vision under stressed conditions simulating twilight and night driving.

Detailed Description
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This is a study of the physiological function of the eyes at night. However, the risk of automobile injury or fatality (driver, passenger or pedestrian) associated with motor vehicle accidents has been determined to increase with age, as a result of the complex interplay of age-related declines in vision, motor and cognitive functioning. However, basic visual function is the foundation for higher order processing whether it is visual spatial or cognitive. Four recent studies reflect the cost of poor vision on driving. (www.visionimpactinstitute.org). For example, visual impairment among European drivers was examined in 2422 drivers from 5 European countries. Visual acuity, visual field, contrast sensitivity, glare sensitivity, and useful field of view were tested. Visual functions not included in the current licensing standards were found to be more impaired among drivers (compared to those functions legally required). Elderly drivers are particularly vulnerable to sensory visual impairment when driving at night, as they suffer declines in both Contrast sensitivity (CS), Glare Disability (GD) and Glare Recovery (GR).6 Justification for study involving humans Carotenoid science is well developed with respect to the safe utilization of dietary lutein (L) /zeaxanthin (Zx) as studied by the National Institute of Health (NEI). The recently published NEI AREDS2 study- May 2013, further substantiated the safety and usefulness of prescribing the carotenoids (10 mg L / 2 mg Zx) in patients at high risk of AMD. 7 Significantly, the average American and veteran population are typically low dose consumer of these carotenoids (1 to 2 mg/day for the average American).

Official Title
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Night Vision and Carotenoids A 2 Center Study of the Physiological Function of the Eyes

Conditions
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Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: EyePromise Visual Edge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No significant supplementary carotenoids within last 10 weeks. Without significant media opacity, cataract or congenital / acquired retinal disease other than atrophic AMD or diabetic retinopathy. Minimum 20/25 to enroll. Exclusion Criteria: Unwilling or medically / psychiatrically unable to take part in a 6 month study. Recent ophthalmologic surgery or treatment. Tricare, Retirees & Enlisted Navy Personnel excluded. Already taking an OTC product to improve their night vision (containing carotenoids, polyphenols like bilberry).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Capsule type that results in null or increased MPOD (macular pigment optical density in du -density units) - either Maltodextrin Placebo or OTC commercial Night Vision Formulation consisting of 21 mg carotenoid capsule (14 mg zeaxanthin and 7mg lutein) supplied by www.zeavision.com (Chesterfield, MO) in research coded bottles with code held by the company. Gel caps will be supplied in a single 180 count bottle. 1 gel cap per day will be taken with a meal. Subjects will be called by telephone to improve compliance. Supplement compliance will ultimately be gauged by the number of tablets returned.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Maltodextrin Placebo: Experimental is 1:2 | Dietary Supplement: EyePromise Visual Edge<br>* A dietary eye supplement containing 8 mg zeaxanthin and 4 mg lutein and additional proprietary nutrients<br>|
| Experimental: Active<br>Eye Promise Visual Edge containing 8 mg zeaxanthin & 4 mg lutein Placebo: Experimental is 1:2 | Dietary Supplement: EyePromise Visual Edge<br>* A dietary eye supplement containing 8 mg zeaxanthin and 4 mg lutein and additional proprietary nutrients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPOD | 1 degree macular pigment optic density | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vimetrics Central Vision Analyzer (CVA) | measure of contrast & glare | 24 weeks | 
| LuxIQ- preferred luminance | preferred luminance | 24 weeks | 
| Useful Field of Vision (UFOV) Brain HQ | eye-brain test of functional vision and vision attention | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Disease