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Macular Pigment Optical Density in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00993330
Recruitment Status : Terminated
First Posted : October 12, 2009
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief Summary:

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.


Condition or disease
Age Related Macular Degeneration

Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Macular Pigment Optical Density in Healthy Subjects
Study Start Date : May 2009
Primary Completion Date : September 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. MPOD as measured with optical reflectometry [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy subjects
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993330


Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhofer, MD Medical University of Vienna

Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. - Doz. Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00993330     History of Changes
Other Study ID Numbers: OPHT-310109
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Gerhard Garhofer, Medical University of Vienna:
macular pigment
to measure macular pigment in the retina

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