"Night Vision and Carotenoids"

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Dietary supplement: EyePromise Visual Edge

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • The Captain James A. Lovell Federal Health Care Center (FHCC)
    • Oak Lawn, Illinois, United States, 60453
      • Davis EyeCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Robert Davis
• Collaborators: Davis EyeCare
• Investigators: Study Director: Steven Novil, PhD, ND, Optometry Research Lab manager, Optometry Clinic- Captain James A Lovell FHCC

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2020

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Macular Disease
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 1052607-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No