Status:
COMPLETED
Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
Lead Sponsor:
Medical University of Vienna
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light ent...
Eligibility Criteria
Inclusion
- Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included, Age-Related Eye Disease Study Research Group 2001)
- Age between 50 and 90 years
- Clear non-lenticular ocular media
- Visual acuity \> 0.4
Exclusion
- Primary retinal pigment epithelium atrophy \> 125 µm
- Moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy
- Participation in a clinical trial in the 3 weeks preceding the study
- Previous treatment with lutein within 3 month of study initiation
- History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
- Ocular surgery within the last 6 months
- Treatment with photosensitizing drugs
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00879671
Start Date
November 1 2006
End Date
May 1 2011
Last Update
November 14 2014
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria