Macular Pigment and Glare Disability (MP-GD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00909090|
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : July 13, 2020
Last Update Posted : July 13, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|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|
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
- 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
- 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909090
|United States, Georgia|
|Vision Sciences Laboratory, UGA|
|Athens, Georgia, United States, 30602|
|Principal Investigator:||Billy R Hammond, Ph.D.||University of Georgia|