Macular Pigment Optical Density in Healthy Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00993330
First received: October 9, 2009
Last updated: November 18, 2009
Last verified: November 2009

October 9, 2009
November 18, 2009
May 2009
December 2009   (final data collection date for primary outcome measure)
MPOD as measured with optical reflectometry [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00993330 on ClinicalTrials.gov Archive Site
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Macular Pigment Optical Density in Healthy Subjects
Macular Pigment Optical Density in Healthy Subjects

The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. 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 these absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.

Measurement of macular pigment is difficult and the investigators have recently proposed a way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There is increased interest in these measurements in the recent years, because a number of studies has provided evidence that low fruit and vegetable consumption increases the risk of age related macular degeneration (AMD). The present study investigates MP optical density (OD) in healthy volunteers and is used to form a database.

Furthermore the nutritional habits and the influence on MP density will be evaluated.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Healthy subjects

Age Related Macular Degeneration
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  • 1
    20 healthy subjects between 18 and 40 years
  • 2
    20 healthy subjects between 41 and 50 years
  • 3
    20 healthy subjects between 51 and 60 years
  • 4
    20 healthy subjects between 61 and 70 years
  • 5
    20 healthy subjects between 71 and 80 years
  • 6
    20 healthy subjects between 81 and 90 years
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
March 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects without any signs of AMD
  • Age between 18 and 90 years, (20 subjects aged between 18 and 40, 20 subjects aged between 41 and 50, 20 subjects aged between 51 and 60, 20 subjects aged between 61 and 70, 20 subjects aged between 71 and 80, 20 subjects aged between 81 and 90)
  • Clear non-lenticular ocular media
  • Visual acuity > 0.6

Exclusion Criteria:

  • Any sign of AMD, or another retinal or optic nerve head disease
  • Ocular surgery within the last 6 months
  • Treatment with photosensitizing drugs
Both
18 Years to 90 Years
Yes
Contact: Gerhard Garhofer, MD 0043 1 40400 2981 ext 2981 gerhard.garhoefer@meduniwien.ac.at
Austria
 
NCT00993330
OPHT-310109
Yes
Gerhard Garhofer, MD, Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
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Principal Investigator: Gerhard Garhofer, MD Medical University of Vienna
Medical University of Vienna
November 2009

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