Macular Pigment and Glare Disability (MP-GD)

June 26, 2020 updated by: Billy R. Hammond, University of Georgia

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Athens, Georgia, United States, 30602
        • Vision Sciences Laboratory, UGA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention
10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin
10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year
Other Names:
  • FloraGlo lutein + OptiSharp zeaxanthin
PLACEBO_COMPARATOR: Placebo
visually identical placebo
Visually identical placebo, taken once daily for one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every three months for one year; 12-month measure reported.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-month data point only
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
improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)
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.
12-month data point only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (ESTIMATE)

May 27, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • UGA-2009-10141-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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