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Completed

NCT Number: NCT04741763

"Night Vision and Carotenoids"

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Captain James A. Lovell Federal Health Care Center (FHCC), North Chicago, Illinois, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

EyePromise Visual Edge

Dietary Supplement

A dietary eye supplement containing 8 mg zeaxanthin and 4 mg lutein and additional proprietary nutrients

Primary outcomes

  1. MPOD

    Time frame: 24 weeks

    1 degree macular pigment optic density

Secondary outcomes

  1. Vimetrics Central Vision Analyzer (CVA)

    Time frame: 24 weeks

    measure of contrast & glare

  2. LuxIQ- preferred luminance

    Time frame: 24 weeks

    preferred luminance

  3. Useful Field of Vision (UFOV) Brain HQ

    Time frame: 24 weeks

    eye-brain test of functional vision and vision attention

Sponsors and collaborators

Lead sponsor

Robert Davis

Other

Collaborators

  • Davis EyeCare

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 5, 2021
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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