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.

Study Overview

• Status: Terminated
• Conditions: Age Related Macular Degeneration

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy subjects

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MPOD as measured with optical reflectometry	1 year

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: October 9, 2009
• First Submitted That Met QC Criteria: October 9, 2009
• First Posted (Estimate): October 12, 2009

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: macular pigment; to measure macular pigment in the retina
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: OPHT-310109