Clinical trial NCT00879671: Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
Official title: Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: lutein
nonexudative AMD
MPOD
Supplementary Concepts
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-04-10
Enrollment: 126
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that this absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.

Age-related macular degeneration is the leading cause of blindness among developed countries. The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD). Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD. The present study investigates whether 6 months lutein supplementation increases MP optical density (OD), influences visual acuity, depth and dimension of central scotoma and alters symptoms in patients with AMD.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Macular pigment optical density (MPOD) as measured with optical reflectometry
timeFrame: 5 minutes
Secondary outcomes:
measure: Visual acuity using ETDRS charts
timeFrame: 15 minutes
measure: Central visual field defects assessed with scanning laser scotometry
timeFrame: 30 minutes
measure: Changes in fundus appearance as documented with fundus photos
timeFrame: 5 minutes
measure: Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Opthalmology, Medical University of Vienna
name: Ursula Schmidt-Erfurth, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weigert G, Kaya S, Pemp B, Sacu S, Lasta M, Werkmeister RM, Dragostinoff N, Simader C, Garhofer G, Schmidt-Erfurth U, Schmetterer L. Effects of lutein supplementation on macular pigment optical density and visual acuity in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8174-8. doi: 10.1167/iovs.11-7522.