"Night Vision and Carotenoids"

• Sponsor: Robert Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT04741763
• Collaborator: Davis EyeCare (Other)
• Enrollment: 27
• Locations: 2
• Arms: 2
• Actual Duration (Months): 30.2
• Patients Per Site: 13.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Dietary Supplement: EyePromise Visual Edge	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Care Provider, Investigator)
• Masking Description: Research coded bottles with code held by the sponsor. Gel caps will be supplied in a single 180 count bottle. 1 gel cap per day will be taken with a meal.
• Primary Purpose: Supportive Care
• Official Title: "Night Vision and Carotenoids" A 2 Center Study of the Physiological Function of the Eyes
• Actual Study Start Date: Feb 13, 2018
• Actual Primary Completion Date: Aug 20, 2019
• Actual Study Completion Date: Aug 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. MPOD [24 weeks]

   1 degree macular pigment optic density

Secondary Outcome Measures

1. Vimetrics Central Vision Analyzer (CVA) [24 weeks]

   measure of contrast & glare

2. LuxIQ- preferred luminance [24 weeks]

   preferred luminance

3. Useful Field of Vision (UFOV) Brain HQ [24 weeks]

   eye-brain test of functional vision and vision attention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Captain James A. Lovell Federal Health Care Center (FHCC)	North Chicago	Illinois	United States	60064
2	Davis EyeCare	Oak Lawn	Illinois	United States	60453

Sponsors and Collaborators

• Robert Davis
• Davis EyeCare

Investigators

• Study Director: Steven Novil, PhD, ND, Optometry Research Lab manager, Optometry Clinic- Captain James A Lovell FHCC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Davis, co-investigator, Davis EyeCare
• ClinicalTrials.gov Identifier: NCT04741763
• Other Study ID Numbers: 1052607-1
• First Posted: Feb 5, 2021
• Last Update Posted: Feb 5, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Robert Davis, co-investigator, Davis EyeCare: Macular Disease
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Feb 5, 2021