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The effect of lutein-enriched-egg beverage on progression of Age-related Macular Degeneration, a randomized trial

Completed
Conditions
age related macular degeneration
macula
10047060
Registration Number
NL-OMON33516
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
220
Inclusion Criteria

- Early signs of AMD on fundus photo (drusen, REP changes)
- 50 years and older
- visus > 0.5
- non-smoker (for at least 2 years)
- clear optical media
- no use of supplementation containing lutein or zeaxanthin
- BMI < 30
- No heart disease

Exclusion Criteria

- Diabetes
- Lipid metabolism disease
- Use of statins
- Egg allergie

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Measuring macular pigment optical density, the amount of measurable macular<br /><br>pigment in the macula region. Changes in amount of early macular degeneration<br /><br>signs on fundus photographs (drusen or retinal pigment epithelium changes).<br /><br>Contrast sensitivity.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Assessing morphological changes of the retina, visual acuity, plasma lutein and<br /><br>zeaxanthin levels, field of vision, and rod function. Vascular function by<br /><br>means of Intima media thickness, flow mediated vasodilatation, arterial<br /><br>distensibility, and lipid metabolism will also be measured in the course of<br /><br>this trial.</p><br>
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