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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00879671
First received: April 9, 2009
Last updated: October 9, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention
Age-Related Macular Degeneration
 Dietary Supplement: lutamax (leutein)
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration

Resource links provided by NLM:

Drug Information available for: Lutein
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Macular pigment optical density (MPOD) as measured with optical reflectometry [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity using ETDRS charts [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Central visual field defects assessed with scanning laser scotometry [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Changes in fundus appearance as documented with fundus photos [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: November 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Lutamax
 Dietary Supplement: lutamax (leutein)
leutein 20 mg for 3 months, then lutein 10 mg
Placebo Comparator: 2
Placebo
 Dietary Supplement: placebo
Placebo capsules identical in taste and appearance

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879671

Contacts
Contact: Gerhard Garhöfer, MD +431404002981

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria
Sub-Investigator: Leopold Schmetterer, Prof. Dr.            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ursula Schmidt-Erfurth, Prof. Dr. Department of Opthalmology, Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Leopold Schmetterer, PhD, Prof., Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00879671     History of Changes
Other Study ID Numbers: OPHT-100205
Study First Received: April 9, 2009
Last Updated: October 9, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
lutein
nonexudative AMD
MPOD
Supplementary Concepts

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013