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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00879671
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE April 9, 2009
First Posted Date  ICMJE April 10, 2009
Last Update Posted Date November 14, 2014
Study Start Date  ICMJE November 2006
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
Macular pigment optical density (MPOD) as measured with optical reflectometry [ Time Frame: 5 minutes ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2009)
MPOD as measured with optical reflectometry [ Time Frame: 5 minutes ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2009)
  • Visual acuity using ETDRS charts [ Time Frame: 15 minutes ]
  • Central visual field defects assessed with scanning laser scotometry [ Time Frame: 30 minutes ]
  • Changes in fundus appearance as documented with fundus photos [ Time Frame: 5 minutes ]
  • Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations [ Time Frame: 5 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
Official Title  ICMJE Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • Dietary Supplement: lutamax (leutein)
    leutein 20 mg for 3 months, then lutein 10 mg
  • Dietary Supplement: placebo
    Placebo capsules identical in taste and appearance
Study Arms  ICMJE
  • Active Comparator: 1
    Lutamax
    Intervention: Dietary Supplement: lutamax (leutein)
  • Placebo Comparator: 2
    Placebo
    Intervention: Dietary Supplement: placebo
Publications * Weigert G, Kaya S, Pemp B, Sacu S, Lasta M, Werkmeister RM, Dragostinoff N, Simader C, Garhöfer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2009)
126
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00879671
Other Study ID Numbers  ICMJE OPHT-100205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Garhofer, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ursula Schmidt-Erfurth, Prof. Dr. Department of Opthalmology, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP