N/A
N=109
Macular Pigment and Glare Disability
Vision, Entoptic
Bottom Line
View on ClinicalTrials.gov: NCT00909090 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Macular Pigment Optical Density — 0.54; 0.42 optical density — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 12 mg Lutein + Zeaxanthin (Dietary_supplement); Visually identical placebo (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Georgia
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Macular Pigment Optical Density |
0.54; 0.42 | 0.01 sig |
| SECONDARY Glare Disability |
1.81; 1.83 | 0.21 |
| SECONDARY Photostress Recovery Time |
10.5; 4.5 | 0.01 sig |
| SECONDARY Heterochromatic Contrast Sensitivity |
1.21; 1.16 | 0.02 sig |
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.
Eligibility 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 30
- Age 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
Data sourced from ClinicalTrials.gov (NCT00909090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.