Macular Pigment Optical Density in Healthy Subjects

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00993330
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 5

Study Details

Study Description

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	Intervention/Treatment	Phase
Age Related Macular Degeneration

Study Design

• 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 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. MPOD as measured with optical reflectometry [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. - Doz. Dr, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT00993330
• Other Study ID Numbers: OPHT-310109
• First Posted: Oct 12, 2009
• Last Update Posted: Nov 14, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Gerhard Garhofer, Assoc. Prof. Priv. - Doz. Dr, Medical University of Vienna: macular pigment; to measure macular pigment in the retina
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Nov 14, 2014