Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Macular Pigment Optical Density in Healthy Subjects

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00993330
First received: October 9, 2009
Last updated: November 13, 2014
Last verified: November 2014

October 9, 2009
November 13, 2014
May 2009
September 2010   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Healthy subjects

Age Related Macular Degeneration
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
96
December 2010
September 2010   (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 information is only displayed when the study is recruiting subjects
Austria
 
NCT00993330
OPHT-310109
Yes
Gerhard Garhofer, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Gerhard Garhofer, MD Medical University of Vienna
Medical University of Vienna
November 2014

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