Macular Pigment and Glare Disability

NCT00909090 | Completed Results DMC

• 1 other identifier: UGA-2009-10141-1
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Vision, Entoptic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Macular Pigment Optical Density

  optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity

  every three months for one year; 12-month measure reported.

Secondary Outcomes (3)

• Glare Disability

  12-month data point only

• Photostress Recovery Time

  improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)

• Heterochromatic Contrast Sensitivity

  12-month data point only

Study Arms (2)

Intervention

ACTIVE COMPARATOR

10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin

Dietary Supplement: 12 mg Lutein + Zeaxanthin

Placebo

PLACEBO COMPARATOR

visually identical placebo

Dietary Supplement: Visually identical placebo

Interventions

12 mg Lutein + Zeaxanthin DIETARY_SUPPLEMENT

10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year

Also known as: FloraGlo lutein + OptiSharp zeaxanthin

Intervention

Visually identical placebo DIETARY_SUPPLEMENT

Visually identical placebo, taken once daily for one year

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: male, female, other, non-conforming
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Georgia: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Vision Sciences Laboratory, UGA

Athens, Georgia, 30602, United States

Location

Related Publications (2)

• 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.

  PMID: 25468896 DERIVED

• 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.

  PMID: 23211814 DERIVED

MeSH Terms

Interventions

Lutein; Zeaxanthins

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Limitations and Caveats

Sample included only young, healthy adults with acute vision. Because the sample was recruited from the local college student population, there were high rates of attrition (students moving away, forgetting appointments, discontinuing contact)

Results Point of Contact

• Title: Dr. Billy Hammond, Principal Investigator
• Organization: University of Georgia

bhammond@uga.edu

(706) 54204812

Study Officials

• Billy R Hammond, Ph.D.

  University of Georgia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two arms: nutritional supplement vs. placebo.

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 27, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 13, 2020
• Results First Posted: July 13, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)