Macular Pigment Optical Density in Healthy Subjects

NCT00993330 | Terminated DMC

• 1 other identifier: OPHT-310109
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

macular pigment; to measure macular pigment in the retina

Outcome Measures

Primary Outcomes (1)

• MPOD as measured with optical reflectometry

  1 year

Study Arms (6)

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 Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy subjects

You may qualify if:

• 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

You may not qualify if:

• Any sign of AMD, or another retinal or optic nerve head disease
• Ocular surgery within the last 6 months
• Treatment with photosensitizing drugs

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Gerhard Garhofer, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. - Doz. Dr

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 12, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

AU (1)