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Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration

NCT ID: NCT00879671

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Lutamax

Group Type ACTIVE_COMPARATOR

lutamax (leutein)

Intervention Type DIETARY_SUPPLEMENT

leutein 20 mg for 3 months, then lutein 10 mg

2

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules identical in taste and appearance

Interventions

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lutamax (leutein)

leutein 20 mg for 3 months, then lutein 10 mg

Intervention Type DIETARY_SUPPLEMENT

placebo

Placebo capsules identical in taste and appearance

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. Priv.-Doz.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ursula Schmidt-Erfurth, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Opthalmology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

Reference Type DERIVED
PMID: 37702300 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21873668 (View on PubMed)

Other Identifiers

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OPHT-100205

Identifier Type: -

Identifier Source: org_study_id