Age-Related Macular Degeneration
Conditions
Keywords
macular pigment, lutein, age-related macular degeneration, AMD
Brief summary
Rationale: Age-related macular degeneration is the most common cause of blindness in the industrialized world. Macular pigment is hypothesized to protect against the vision loss in this disease. Objective: 1. To study if the macular pigment optical density can be raised by lutein supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in visual functions. Study design: Randomized, double blind, placebo controlled intervention study. Study population: Eighty patients with early signs of age-related macular degeneration Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the control group (40 subjects) gets a placebo.
Interventions
DIETARY_SUPPLEMENTLutein
Lutein supplement, 10 mg daily
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Cognis Deutschland GmbH & Co. KG
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* AMD grade 2 or 3 * visual acuity \> 0.5 * BMI \< 30
Exclusion criteria
* using lutein supplements * smoking * diabetes * diseases that interfere with lipid absorption * other eye diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular Pigment Optical Density | Baseline, 4 months, 8 months, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Visual Acuity | Baseline, 4 months, 8 months, 12 months |
Countries
Netherlands, United Kingdom
Outcome results
None listed