"Night Vision and Carotenoids"

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741763
• Other study ID #: 1052607-1
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: August 20, 2020

Study information

• Verified date: February 2021
• Source: Davis EyeCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Dietary Supplement:
• EyePromise Visual Edge
A dietary eye supplement containing 8 mg zeaxanthin and 4 mg lutein and additional proprietary nutrients

Locations

Country	Name	City	State
United States	The Captain James A. Lovell Federal Health Care Center (FHCC)	North Chicago	Illinois
United States	Davis EyeCare	Oak Lawn	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Robert Davis	Davis EyeCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPOD	1 degree macular pigment optic density	24 weeks
Secondary	Vimetrics Central Vision Analyzer (CVA)	measure of contrast & glare	24 weeks
Secondary	LuxIQ- preferred luminance	preferred luminance	24 weeks
Secondary	Useful Field of Vision (UFOV) Brain HQ	eye-brain test of functional vision and vision attention	24 weeks