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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
History of Changes
  Purpose

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
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Macular Pigment Optical Density in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • MPOD as measured with optical reflectometry [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993330

Contacts
Contact: Gerhard Garhofer, MD 0043 1 40400 2981 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhofer, MD     00431 40400 ext 2981     gerhard.garhoefer@meduniwien.ac.at    
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhofer, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, MD, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00993330     History of Changes
Other Study ID Numbers: OPHT-310109
Study First Received: October 9, 2009
Last Updated: November 18, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013