Macular Pigment and Glare Disability (MP-GD)

• ClinicalTrials.gov Identifier: NCT00909090
• Recruitment Status: Completed
• First Posted: May 27, 2009
• Results First Posted: July 13, 2020
• Last Update Posted: July 13, 2020
• Sponsor: University of Georgia
• Collaborator: DSM Nutritional Products, Inc.
• Information provided by (Responsible Party): Billy R. Hammond, University of Georgia

Study Description

Brief Summary:

The purpose of this study is:

I. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.

II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions.

III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.

IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.

Condition or disease	Intervention/treatment	Phase
Vision, Entoptic	Dietary Supplement: 12 mg Lutein + Zeaxanthin; Dietary Supplement: Visually identical placebo	Not Applicable

Detailed Description:

The following measurements will be taken, before and after supplementation with lutein and zeaxanthin:

Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two arms: nutritional supplement vs. placebo.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study
• Study Start Date: May 2009
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Intervention; 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin	Dietary Supplement: 12 mg Lutein + Zeaxanthin; 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year; Other Name: FloraGlo lutein + OptiSharp zeaxanthin
Placebo Comparator: Placebo; visually identical placebo	Dietary Supplement: Visually identical placebo; Visually identical placebo, taken once daily for one year

Outcome Measures

Primary Outcome Measures :

1. Macular Pigment Optical Density [ Time Frame: every three months for one year; 12-month measure reported. ]
   optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity

Secondary Outcome Measures :

1. Glare Disability [ Time Frame: 12-month data point only ]
   light energy needed to obscure or veil a visual target; calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.
2. Photostress Recovery Time [ Time Frame: improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec) ]
   amount of time needed to recover from exposure to a bright light, and to regain sight of a visual target
3. Heterochromatic Contrast Sensitivity [ Time Frame: 12-month data point only ]
   amount of short-wave light energy necessary to obscure of veil a visual target, calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: male, female, other, non-conforming
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Gender: male or female
• Age: 18 - 40 years
• BMI: 20-30
• No anticipated changes in dieting habits (as relevant to xanthophyll intake).
• No anticipated surgical procedures.
• Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.
• Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
• Corrected visual acuity (ETDRS): better than 20/60

Exclusion Criteria:

• BMI <20 or >30
• Age <18 or >40 years
• Smokers
• Current or history of relevant diseases (such as AMD)
• Corrected visual acuity worse than 20/60
• Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
• Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
• Current use of xanthophyll containing supplements
• Use of xanthophyll containing supplements in the past 6 months
• Participation in any other study during last 1 month.
• Blood donation during the last 3 months.
• Known hypersensitivity or allergy to xanthophylls.
• Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
• Suspected lack of compliance with any requirements of the study.
• Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).
• Current pregnancy or breast feeding
• Any relevant abnormalities in the routine laboratory tests

Contacts and Locations

Locations

United States, Georgia

Vision Sciences Laboratory, UGA

Athens, Georgia, United States, 30602

Sponsors and Collaborators

University of Georgia

DSM Nutritional Products, Inc.

Investigators

• Principal Investigator: Billy R Hammond, Ph.D.; University of Georgia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hammond BR, Fletcher LM, Roos F, Wittwer J, Schalch W. A double-blind, placebo-controlled study on the effects of lutein and zeaxanthin on photostress recovery, glare disability, and chromatic contrast. Invest Ophthalmol Vis Sci. 2014 Dec 2;55(12):8583-9. doi: 10.1167/iovs.14-15573.

Hammond BR Jr, Fletcher LM, Elliott JG. Glare disability, photostress recovery, and chromatic contrast: relation to macular pigment and serum lutein and zeaxanthin. Invest Ophthalmol Vis Sci. 2013 Jan 17;54(1):476-81. doi: 10.1167/iovs.12-10411.

• Responsible Party: Billy R. Hammond, Professor, University of Georgia
• ClinicalTrials.gov Identifier: NCT00909090
• Other Study ID Numbers: UGA-2009-10141-1
• First Posted: May 27, 2009
• Results First Posted: July 13, 2020
• Last Update Posted: July 13, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Billy R. Hammond, University of Georgia:

macular pigment; glare disability; lutein; photostress; chromatic contrast sensitivity