Macular DegenerationNCT04741763
"Night Vision and Carotenoids"
A study testing EyePromise Visual Edge in people with Macular Degeneration, run by Robert Davis at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- EyePromise Visual Edge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Feb 2018to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Captain James A. Lovell Federal Health Care Center (FHCC)
North Chicago, Illinois, 60064
Davis EyeCare
Oak Lawn, Illinois, 60453
About this study
Official title: "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.
Read the 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).
- Conditions
- Macular Degeneration
- Being tested
- EyePromise Visual Edge
- Keywords
- Macular Disease
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyePromise Visual EdgeDietary supplement
A dietary eye supplement containing 8 mg zeaxanthin and 4 mg lutein and additional proprietary nutrients
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin Placebo: Experimental is 1:2 Receives: Dietary Supplement: EyePromise Visual Edge |
| Active | Experimental | Eye Promise Visual Edge containing 8 mg zeaxanthin \& 4 mg lutein Placebo: Experimental is 1:2 Receives: Dietary Supplement: EyePromise Visual Edge |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPOD
1 degree macular pigment optic density
Measured: 24 weeks
Secondary outcomes (3)
Vimetrics Central Vision Analyzer (CVA)
measure of contrast \& glare
Measured: 24 weeks
LuxIQ- preferred luminance
preferred luminance
Measured: 24 weeks
Useful Field of Vision (UFOV) Brain HQ
eye-brain test of functional vision and vision attention
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start13 Feb 2018
- Primary completion20 Aug 2019
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Davis EyeCare
- Responsible party
- Sponsor-investigator, Robert Davis, Davis EyeCare
- Investigators
- Steven Novil, PhD, ND, Study director, Optometry Research Lab manager, Optometry Clinic- Captain James A Lovell FHCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741763
- Sponsor's protocol ID
- 1052607-1
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Night Vision and Carotenoids" A 2 Center Study of the Physiological Function of the Eyes
- ClinicalTrials.gov ID
- NCT04741763
- Acronym / sponsor ID
- 1052607-1
- Conditions
- Macular Degeneration
- Keywords
- Macular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Robert DavisUniversity, hospital or other
- Collaborators
- Davis EyeCare
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: EyePromise Visual EdgeMaltodextrin Placebo: Experimental is 1:2 |
| Active | Experimental | Dietary Supplement: EyePromise Visual EdgeEye Promise Visual Edge containing 8 mg zeaxanthin \& 4 mg lutein Placebo: Experimental is 1:2 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyePromise Visual EdgeA dietary eye supplement containing 8 mg zeaxanthin and 4 mg lutein and additional proprietary nutrients | Dietary supplement | Active, Placebo |
Primary outcome
MPOD
Time frame: 24 weeks
1 degree macular pigment optic density
3 secondary outcomes
Vimetrics Central Vision Analyzer (CVA)
Time frame: 24 weeks
LuxIQ- preferred luminance
Time frame: 24 weeks
Useful Field of Vision (UFOV) Brain HQ
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Novil, PhD, ND study director
Optometry Research Lab manager, Optometry Clinic- Captain James A Lovell FHCC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EyePromise Visual Edge in people with Macular Degeneration, run by Robert Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPOD (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.