Clinical trial NCT04741763: "Night Vision and Carotenoids"
Official title: "Night Vision and Carotenoids" A 2 Center Study of the Physiological Function of the Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Keywords: Macular Disease
Lead sponsor: Davis EyeCare
Sponsor class: OTHER
Collaborators: name: Davis EyeCare
First posted: 2021-02-05
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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).

Primary outcomes:
measure: MPOD
timeFrame: 24 weeks
Secondary outcomes:
measure: Vimetrics Central Vision Analyzer (CVA)
timeFrame: 24 weeks
measure: LuxIQ- preferred luminance
timeFrame: 24 weeks
measure: Useful Field of Vision (UFOV) Brain HQ
timeFrame: 24 weeks
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: The Captain James A. Lovell Federal Health Care Center (FHCC)
state: Illinois
city: Oak Lawn
country: United States
facility: Davis EyeCare
state: Illinois
Study officials:
affiliation: Optometry Research Lab manager, Optometry Clinic- Captain James A Lovell FHCC
name: Steven Novil, PhD, ND
role: STUDY_DIRECTOR
References: